SOP for Internal Quality Audit (Self Inspection)
1.0 OBJECTIVE:
To lay down the procedure for self inspection (internal quality audit) at [Company] in various department of organisation.
2.0 SCOPE:
This Standard Operating Procedure (SOP) is for inter department quality audits as per the planned schedule. The various departments covered are Production, Quality Assurance (QA) / In process quality Assurance (IPQA), Quality Control (QC)/microbiology, Engineering/utility, HR department/Administration & warehouse/store.
3.0 RESPONSIBILITY:
Head QA / Designee
Ensure the compliance of this SOP
Preparation of self audit schedule
Annual review of the self audit report
Review of self audit report before any regulatory audits
Ensure that self audit schedule is followed
Individual Department HOD’s /Designee
To prepare the compliance report
To coordinate internal auditors during audits
Self Inspection Team
To carry out the self inspection audits at the plan schedule
To check the adherence to cGMP compliance
To prepare non conformance report
4.0 PROCEDURE:
Internal quality audit conducted in plant in following ways:
A Scheduled self-inspection governed through checklist.
B Focussing audit by QA department (Random / unplanned)
C Audit by outside agencies or corporate QA.
A Scheduled self-inspection governed through checklist.
4.1 Preparation of self inspection schedule
4.1.1 Head QA / Designee shall prepare the self inspection schedule
4.1.2 Schedule shall be prepared for the calendar year (i.e. from January to December)
4.1.3 The schedule for self-inspection shall be prepared & approved for the forthcoming year at the end of the current year i.e. in the month of December.
4.1.4 Schedule shall be prepared as per the Annexure-I
4.2 Systems to be Audited:
4.2.1 FACILITY AND EQUIPMENT:
4.2.1.1 Canteen
4.2.1.2 List of Equipment /Instruments
4.2.1.3 Qualification of Equipment/ Instruments
4.2.1.4 Design Qualification
4.2.1.5 Installation Qualification
4.2.1.6 Operational Qualification
4.2.1.7 Performance Qualification
4.2.1.8 Sewage and rejects
4.2.1.9 Equipment design, size, and location.
4.2.1.10 Equipment construction
4.2.1.11 Automatic, mechanical, and electronic equipment.
4.2.1.12 Change rooms
4.2.1.13 Wash rooms
4.2.1.14 Preventive maintenance
4.2.1.15 Cleaning and operation procedure
4.2.2 MATERIAL MANAGEMENT:
4.2.2.1 Raw Material Store
4.2.2.2 Packing Material Store
4.2.2.3 Finished Goods store
4.2.2.4 Toxic /Hazardous material storage
4.2.2.5 Cold Storage (if applicable)
4.2.2.6 Scrap Yard Management
4.2.3 PRODUCTION AND PROCESS CONTROL:
4.2.3.1 Change rooms
4.2.3.2 Gowning procedure
4.2.3.3 In process checks
4.2.3.4 Written Procedures (SOP’s)
4.2.3.5 Deviations
4.2.3.6 Charge – in of components
4.2.3.7 Calculation of yield
4.2.3.8 Equipment identification
4.2.3.9 Sampling and testing of in process materials and drug products
4.2.3.10 Time limitation on production
4.2.3.11 Reprocessing (if any)
4.2.3.12 Control of microbiological contamination
4.2.4 PACKAGING AND LABELLING CONTROL:
4.2.4.1 Material examination and labelling control
4.2.4.2 Labelling issuance
4.2.4.3 Packaging and labelling operations
4.2.4.4 Tamper – resistant packaging requirement human drug products.
4.2.4.5 Drug product inspection
4.2.4.6 Expiration date
4.2.5 QUALITY ASSURANCE:
4.2.5.1 Site Master File
4.2.5.2 Validation Master File
4.2.5.3 Master SOPs, Protocol, Master List
4.2.5.4 Change Control Programme
4.2.5.5 Deviation
4.2.5.6 Incidents
4.2.5.7 Out of specification
4.2.5.8 Rejection/ Approval
4.2.5.9 CAPA
4.2.5.10 Document and Data control
4.2.5.11 Quality Manual
4.2.5.12 Annual product quality review
4.2.5.13 Market complaint, Market Return, Product Recall
4.2.5.14 Validation (Qualification) Documents
4.2.5.15 Processes Validation
4.2.5.16 Cleaning Validation
4.2.5.17 Analytical Method Validation
4.2.5.18 Specification of RM, PM, and Finished Goods and it’s Updation
4.2.5.19 General Test Procedure
4.2.5.20 Batch Manufacturing/ Packing Record (BMR/BPR)
4.2.5.21 Stability Study
4.2.5.22 Drawings
4.2.5.23 Product License
4.2.5.24 Dossier
4.2.5.25 Organogram
4.2.5.26 Job responsibility
4.2.5.27 Signature log
4.2.5.28 Induction programme
4.2.5.29 Training
4.2.5.30 Self inspection
4.2.5.31 Vendor details
4.2.5.32 Control sample
4.2.5.33 In process checks and line clearance
4.2.6 Quality Control Laboratory
4.2.6.1 General requirement
4.2.6.2 Testing and release for distribution
4.2.6.3 Analytical records
4.2.6.4 Calibrations
4.2.6.5 External agency testing
4.2.6.6 Equipment Cleaning And Use Records
4.2.6.7 Laboratory records
4.2.6.8 Certificates of analysis
4.2.6.9 Analyst certification
4.2.7 SAFETY SYSTEMS
4.2.7.1 Security
4.2.7.2 Pollution control
4.2.7.3 Fire extinguisher
4.2.7.4 Fire hydrant
4.2.7.5 Smoke detector
4.2.7.6 Emergency alarm
4.2.8 UTILITY SYSTEM:
4.2.8.1 Calibration of Measuring Instruments
4.2.8.2 Equipment cleaning and maintenance
4.2.8.3 HVAC system and Drawings
4.2.8.4 Water
4.2.8.5 Compressed air
4.2.8.6 ETP & disposable waste
4.2.8.7 Environmental Monitoring
4.2.8.8 Temperature
4.2.8.9 Relative Humidity
4.2.8.10 Pressure Differential
4.2.9 HEALTH AND HYGIENE SYSTEM:
4.2.9.1 Medical Check up
4.2.9.2 Pest / rodent control
4.2.9.3 First Aid
4.2.9.4 Sanitization
4.3 Self inspection team
4.3.1 The team shall consist of at least 2 cross-functional department /section heads or his designee based on Internal Customer Concept along with department head /designee.
4.3.2 The Auditor shall have the education, training, experience or any combination there of to perform the assign function.
4.4 Correspondence
4.4.1 Head QA/ Designee shall circulate the yearly self-inspection schedule in the month of December for the next year.
4.4.2 Scheduled inspection may be reminded 3 – 7 days in advance.
4.5 Procedure for self-inspection.
4.5.1 Need based reshuffling of department in the Schedule shall be through planned deviation only.
4.5.2 The self-inspection shall be carried out as per the schedule +7 days.
4.5.3 The audit can be of facility as a whole or departmental.
4.5.4 From here onwards the team performing the inspection shall read as Auditor(s) and the person(s) facing the inspection as Auditee(s). The self-inspection procedure as Audit.
4.5.5 Department wise checklist based on cGMP may be prepared to facilitate the inspection.
4.5.6 The auditor may procure the checklist from QA department before self-inspection. Auditors may use this checklist or appropriate.
4.5.7 The audit shall be carried for systems as per point no 4.2 (4.2.1 to 4.2.9) as applicable.
4.5.8 Compliance status for previous audit findings /NCR shall be checked before the next audit. During self-inspection also check the compliance level of audit observation made by external agency or any regulatory body. Also access the compliance level of audit carried out by customer.
4.5.9 Each of the areas shall be inspected and audited as per annual calendar schedule.
4.5.10 Each of the areas shall be inspected on half yearly basis. The parameters to be covered shall include compliance with cGMP (current Good Manufacturing Practices), cGLP (current Good Laboratory Practices), cGWP (current Good Warehouse Practices), GEP (Good Engineering Practices) and safety etc.
4.5.11 The audit scope may be narrowed down to cover only particular segment activity.
4.5.12 Team of Auditor shall prepare a full report of the audit findings in Annexure – II
4.5.13 The audit findings/ NCR shall be briefed to Auditee on the spot or in closing meet. One copy of this shall be submitted to Head QA.
4.5.14 The NCR/findings shall be categorized as Critical /Major /Minor.
4.5.15 Criteria for categorization shall be
4.5.15.1 CRITICAL: Which immediate and directly affects the quality, safety, purity, identity, strength, stability, efficacy of product and which is not complying cGMP practices. Corrective action to be taken immediately.
4.5.15.2 MAJOR: Which indirectly affects the quality, safety, and purity, identity, strength, stability, efficacy of product and which is not complying cGMP practices. Corrective action to be taken immediately.
4.5.15.3 MINOR: Defects, which can be noted but not quality impacting and corrected at scheduled program.
4.5.16 The audit findings/NCR shall be recorded as per Annexure – II.
4.5.17 Completed audit report shall be submitted to Auditee within two (2) working days after the audit.
4.5.18 Compliance, proposed action plan, target date of completion shall be decided between Auditor & Auditee based on the severity of the matter.
4.5.19 Auditee shall submit the compliance, proposed action plan, target date of completion and responsibility of person as per Annexure II within three (3) working days.
4.5.20 Auditor shall review the compliance, proposed action plan, target date of completion within 3 working days.
4.5.21 Any non conformance observed during self inspection shall be handled by taking corrective action and preventive action and same shall be entered in CAPA register.
4.5.22 Auditor & Head QA shall send the audit findings along with compliance, proposed action plan, target date of completion to CQA annually (at the end of the year).
4.6 Closure of Audit observation / NCR
4.6.1 Closure shall be on the basis of data, document, physical verification or reinspection & the same shall be recorded in the column provided as per annexure II with closing status. The auditors report shall be agreed on findings based on factual evidence. It is necessary to record.
4.6.2 Closure shall include minimum one of the following as corrective action:
4.6.2.1 Training
4.6.2.2 SOP / Document preparation or upgradation.
4.6.2.3 Resource management
4.6.3 In case of NCR/findings, not complied & implemented by target date of completion, the compliance date can be revised in coordination with Auditor and QA – Head, by providing proper justification and requesting for extension of CAPA dates.
B Focussing audit by QA department (Random / unplanned)
4.7 QA head designate any person from QA department for Random / unplanned audit on any area in any department by focussing on single system. This shall be done as under:
4.7.1 Any person from QA department who is trained for this sop can take a round to any department for observing compliance of system.
4.7.2 He/ She can focus on specific area and check the working of system.
4.7.3 He/ She can ensure traceability on documents, training records, any technical aspects etc,
4.7.4 The responsible person for conducting the system /activities are to be with QA person while inspecting the compliance.
4.7.5 Any non-conformance (NCR) observed to be note down in annexure –XI. (Triplicate copy white / blue / pink)
4.7.6 QA person fill the NCR report and put the details of NCR observed and hand over the report to concern department Head, who will fill the reason for NCR, corrective action, preventive action and Target completion date (TCD) and return white and blue copy.
4.7.7 Blue copy forwarded to Unit Head for information.
4.7.8 On completion of target date QA person verify the non-conformance status and put the compliance status sign and date on NCR report.
4.7.9 White copy of NCR remain in QA department for reference and blue and pink copy torn off as soon as corrective action taken.
4.7.10 All non-conformances observed in different section will be reviewed once in three month and discussed in management meeting for further action.
4.7.11 Any supporting document generated for compliance of NCR will be attached to white copy and remain in QA department.
C Audit by outside agencies or corporate QA.
All audit conducted by external agency / party or corporate QA is as per their guideline and forever. Local QA department will keep records of compliance of those audits wherever applicable. This report will be filed in audit file.
4.8 Summarisation of findings/NCR
4.8.1 Trend charting of observation/ NCR shall be done once a year
4.8.2 Trend charting shall be done as per Annexure – III
4.8.3 Category wise (Critical / Major / Minor)
4.8.4 Department wise.
4.8.5 Critical and repeated findings shall be reviewed in Quality review meetings and shall be discussed with top management.
5.0 ANNEXURES
Annexure – I: Self Inspection Schedule Calendar
Annexure – II: Format for reporting NCR / Findings
Annexure – III: Trend Charting
Annexure – IV: Checklist for self inspection of Quality Assurance Department
Annexure – V: Checklist for self inspection of Quality Control Department
Annexure – VI: Checklist for self inspection of IPQA Department
Annexure – VII: Checklist for self inspection of Engineering Department
Annexure – VIII: Checklist for self inspection of Production Department
Annexure – IX: Checklist for self inspection of Packaging Department
Annexure – X: Checklist for self inspection of Warehouse Department
Annexure – XI: Non Conformance Report
Annexure – I: Internal Quality Audit Schedule
Department
Raw material Stores
Packing Material Stores
Finished goods Stores
Production
Engineering & Utility
Quality Control & Microbiology
Quality Assurance/IPQA
HR and Administration
Audit Team Member: Two cross-functional department Heads shall be finalized by Head QA before 10 days, information will be circulated.
Tolerance: Schedule date ± 7 days
Prepared by
Checked By
Annexure – II: Internal Quality Audit NCR / Findings
Audit Summary
Observation
Action Plan
Responsibility
TCD
Closure
Status
Auditor (Sign/Date)
Auditee (Sign/Date)
Internal Quality Audit NCR / Findings
Date of audit
Location
Time of Audit
Department
Auditor
Auditee
No of Observation/ NCR
Audit Observation/ NCR sent on
Response Received on
Concluding Remark
Annexure – III: Trend charting
Department
Findings/ NCR
Repeated
Annexure IV: Self Inspection Checklist for Quality Assurance
A. General
01. Check the availability of departmental Organogram
02. Job responsibility is assigned to the each and every personnel working the department
03. All the personnel working in the department were qualified and trained.
04. SOP’s for the related activities are made available at the site of actual operation.
05. Machine logbooks & cleaning record etc. are stored and maintained.
06. Calibration record for the measuring / monitoring devices are stored and maintained.
07. All the gauges, sensors, measuring devices are calibrated and its record is available.
08. Check the Updated & authorized site master file
09. List of Standard operating procedure of all departments
10. Standard Operating procedure on preparation, review, approval and control of SOP.
11. Signature log containing initial and full signature of all employee
12. Check the updated and authorized validation master plan (VMP).
13. Verify the Procedure of document and data control
14. Management & review of manufacturing licenses obtained from local FDA
15. Verify the procedure of handling of expired documents.
16. Review and approval of all the calibration certificates received from the external agencies.
17. Procedure for review of MMD, TMD, TAD, Specification and other controlled documents
18. Verify the procedure for issue, retrieval, preservation, destruction of MMD, TMD, TAD, Specification and other controlled documents
19. Verify the records for handling Deviation / Incidents.
20. Verify the records for Deviation / Incidents and review of CAPA if applicable.
21. Verify the records for Procedure for handling change control proposal.
22. Verify the records for Change control proposal log and its approval / closure records.
23. Verify Trending of change control proposal.
24. Authorized person for handling market complaints Records with sops
25. Check the Market Complaint log.
26. Verify the Procedure for handling market complaint and methodology used for investigation of the complaint
27. Procedure for product recall / mock recall.
28. Implementation of CAPA
29. Verify the Procedure of handling out of specification / failure investigation
30. Check the Closure of OOS and failure investigation
31. Verify Procedure for self-inspection.
32. Check the availability of authorized self-inspection schedule.
33. Check the records of self-inspection.
34. Verify the procedure for management review.
35. Check the records of training of QA personnel.
36. Check the Quality Manual.
37. Verify the availability of approved vendor list.
38. Verify the procedure for control sample management
39. Verify the Procedure for periodic observation of control sample.
40. Check the Procedure for handling non-conformities observed during periodic observation of control sample.
41. Check the Records for periodic observation of control sample.
42. Verify the environmental monitoring record for control sample storage area.
43. Verify the procedure for handling return goods.
44. Procedure for handling goods return from the market due to the quality reason.
45. Check the Annual Product review Reports
46. Review of annual product review data
47. Check the Implementation of recommendations made in the APR.
48. Check the Agreement with the contract analytical laboratory.
49. Procedure for handling out of specification occurred during analysis at contact analysis laboratory and its records.
50. Check the Contract analytical laboratory audit reports and its compliance report
51. Authority of release of the batch is assigned to Head QA or his designee.
52. Check the Procedure for review of BMR / BPR / Analytical data and release of the batch.
53. Check the List of personnel authorized to release the batch.
54. Check the Procedure for preservation of batch documents or its related documents
55. Check the Procedure for process validation.
56. Check the General criteria for preparation of validation protocol and validation report.
57. Check the Availability of validation policy
58. Check the Procedure for equipment qualification
59. Criteria for revalidation of the process / equipment / utility system.
60. Check the Availability of approved process validation protocol and reports for all the product manufactured.
61. Check the Availability of approved validation / qualification reports for all the equipment / instrument / system in use.
62. Check the Availability of approved cleaning validation protocol and report for chain of equipment used for manufacturing of the product
63. Check the Procedure for management of scrap.
64. Check the Procedure for stability study
65. Defined criteria for short term / long term stability studies.
66. Criteria for tolerance that is allowed in case of deviation from the stability study schedule.
67. Check the availability of approved stability study protocols and reports
68. Check the Environmental monitoring of stability study chambers.
69. Check the Environmental monitoring record for all the stability chambers
70. Check the Qualification reports for the stability chambers
71. Check the Procedure for handling excursion in the stability chambers
72. Check the Procedure for handling OOS test results observed during stability studies.
73. Verify the Criteria for stoppage of stability testing
74. Verify the Procedure for destruction of stability samples.
Any other observation:
Annexure V Self Inspection Checklist for Quality Control
A. Quality Control
01. Verify Updated SOP List
02. Verify List of Technical Persons
03. Verify List of Instruments
04. Check the Organogram
05. Job Responsibilities of Key Personnel (Check for one / two persons randomly)
06. SOP on Training of personnel, Check Training record of one analyst each in Chemical & Instrumental section with respect to training on GMP, Analytical techniques and SOPs.
07. Is the laboratory maintained in a good state of repair?
08. Is the laboratory neat and orderly with sufficient space for instruments & operation?
09. Is there an evidence of good housekeeping?
10. Are all reagents and solutions clearly labeled with name, date of receipt, date of opening, use before date?
11. Is issue record for reagents available?
12. Are prepared solution labeled with prepared by, date of preparation & use before date?
13. Is there an approved annual preventive maintenance (APM) program for all instruments available in the lab? Check compliance. Is the frequency adequate?
14. Is the person / agency carrying out APM qualified to do so?
15. Check for APM of major instruments in the laboratory e.g.
HPLC : ID No.
GC : ID No.
IR Spectrophotometer : ID No.
Dissolution Apparatus : ID No.
Any other :
16. Are calibration / Processes defined? Does it provide for external calibration?
17. Is there any approved calibration schedule for all instruments? Check compliance. Is the frequency adequate?
18. Is there a valid calibration sticker on each instrument?
19. Check SOP on operations, calibration and calibration record for major instruments in the lab e.g.
HPLC : ID No.
GC : ID No.
IR Spectrophotometer : ID No.
Dissolution Apparatus : ID No.
Any other :
20. If any instrument is required to be sent outside for calibration / APM is any established procedure followed?
21. Is history card maintained for each instrument?
22. Is any control form used to include equipment in to the calibration / APM system to change frequency and to remove instrument from calibration / APM system?
23. Cleaning verification of glassware
24. Check SOP on Glassware cleaning
25. Is there an SOP on sample management including receipt, recording, issuance for analysis, storage and destruction after analysis.
26. Is there an SOP on backup of electronic data acquisition e.g. HPLC etc. and its compliance
27. Check for 21 CFR Part II compliance for electronic data in case of HPLC etc. validation & security of computerized / automated processes
28. Whether instruments are in network & its security access
29. Check SOP on “Reference standard / working standard” management program
detailing sourcing, purity and assay, preparation of WS, qualification, storage and stability record for period of maximum storage. Check for current Lot No. of USP reference standard & storage condition.
30. Check analytical data for one RM & FP for the following:
31. Tractability of all instruments used, calibration status, weight details.
32. Adherence to written MOA
33. Reference for preparation of mobile phase ( for HPLC analysis)
34. Tractability of name of manufacturer, Lot No. & use before (if applicable) for all standards used in the analysis
35. Reporting of results upto significant figure.
36. System suitability checks on chromatographic system (e.g. GC / HPLC)
37. Audit Trail
38. Temperature mapping of refrigerator including open / close door recovery study.
39. Check SOP and record for internal audit
40. Check SOP on “Reporting of Analytical results” & its compliance. (e.g. Rounding off, reporting upto significant no. etc.)
41. SOP on deviation / incidents & its compliance & closing. Check for records for last 6 months.
42. Procedure on qualification of instruments. Check IQ / OQ / of two major instruments.
Instrument ID No.
43. Check availability and working of fume hoods.
44. Check storage condition for chemicals and its management.
45. Other observation if any:
B. Microbiology
01. Verify the training Record of Microbiologist?
02. Verify Microbiologist Qualification record?
03. Verify an entry exit procedure for the lab?
04. Verify separate apron for micro lab?
05. Verify hands spray solution to sanitize hand ?
06. Verify bottles properly labeled for prepared on and use before dates?
07. Verify the gowning procedure?
08. Verify the separate gown for MLT Room?
09. Do you have the authorized persons enter to micro lab. Verify the List
10. Verify preparation record of cleaning and disinfectant solution?
11. Verify destruction procedure of left over disinfectant solution and record?
12. Verify the efficacy test of Disinfectant solution.?
13. Verify cleaning and sanitization record of Micro Lab?
14. Verify the cleaning record of equipment.
15. Verify the record of relative humidity record of Micro lab?
16. Verify the pressure Differential record in Micro Lab?
17. Verify the SOP of environmental monitoring Micro Section?
18. Verify record of monitoring environmental by settle plate count?
19. Verify the trend of environmental monitoring?
20. Verify the environmental monitoring by air Sampling?
21. Verify calibration record of weighing balance?
22. Verify weights shall be calibrated by Govt. approved agency?
23. Verify the media management SOP?
24. Verify the media receipt record?
25. Verify the media preparation procedure?
26. Verify the purified water while preparing the media.
27. Verify the media uses and consumption record?
28. Verify the Media growth promotion test?
29. Verify the calibration record of pH meter.?
30. Verify the validation of autoclave periodically?
31. Check the autoclave logbook?
32. Verify the thermograph chart recorded?
33. Do you cover different load pattern in validation?
34. Verify the cleaning record of autoclave?
35. Check the calibration record of oven.?
36. Check the pass box for transferring Materials?
37. Verify the cleaning record of pass box?
38. Verify the records of burning hour of UV Light?
39. Check the cleaning record of Laminar AIR Flow?
40. Check the records of periodic validation of Laminar Air Flow?
41. Check the sampling procedure of sampling of water?
42. Check the log book of water analysis
43. Check the Logbook of Analysis of Finished Product?
44. Check the trend analysis of environmental monitoring?
45. Check the recorded the temperature of incubator?
46. Check the cleaning record of Incubator?
47. Check the media disposal record?
48. Check the validation record of media disposal autoclave?
49. Do you validate the media disposal check the records.
50. Verify the cleaning record of Autoclave?
51. Check the calibration record of Refrigerator?
52. Check the calibration record of Air sampling?
53. Check the Culture Transferring Record?
Any other observation:
Annexure VI: Self Inspection Checklist for Quality Assurance
A. IPQA Lab
01. Verify Procedure for calibration of laboratory instrument
02. Check availability of calibrated weight for calibration of weighing balances
03. Check the calibration status of equipment
04. Check Suitability of Procedure for line / area clearance
05. Check Suitability of Procedure of handling non-conformance observed during manufacturing during in-process checks
06. Check Suitability of Procedure for handling deviations in IPQA
07. Verify Qualification dockets for laboratory instruments
08. Conform Availability of Method of Analysis for performing In-process tests
09. Verify Procedure for review of in BMR/BPR.
10. Conform Availability of sampling devices
11. Check Suitability of Procedure on sampling & sample management
12. Check Suitability of Procedure for handling unforeseen incidents at shop floor
13. Verify Procedure on handling of mix-up and reporting of the same to Head QA
14. Verify Instrument usage logbooks for all laboratory instruments.
15. Verify availability of Calibration schedule for all laboratory instruments
16. Check the calibration record of instruments
17. Check the Procedure of release of intermediates
18. Check the availability of check list for line / area clearance and conform with practice
19. Review of frequency of in process checks and process monitoring
20. Trained and Qualified staff.
Any other observation:
Annexure VII: Self Inspection Checklist for Engineering Department
A. General
01. Is DG restore power supply within 3 minutes.
02. Is DG in Working condition?
03. Job responsibility available for key person.
04. Availability of departmental organogram.
05. All the personnel working in the department are qualified and trained.
06. Availability of the procedure and schedule for preventive maintenance of plant equipment.
07. Procedure on handling breakdown of equipment.
08. Policy on usage contract laboratory for calibration of gauges.
09. SOP’s for the related activities are made available at the site for actual operation.
10. Machine logbooks & cleaning records etc. are stored and maintained as defined in the SOP.
11. Calibration record for the measuring / monitoring devices are stored and maintained as defined in the SOP.
12. All the gauges, sensors, measuring devices are calibrated and its record is available.
13. Maintenance programme / procedure of extinguisher provided in the facility
14. Agreement with contract laboratory for calibration of critical gauges, measuring and monitoring devices available.
15. Procedure and record of calibration of Master equipment / instrument available.
16. Availability of Approved plant layouts, Drawings for Water System, HVAC system, Pressure Zoning, Man & Material movement etc.
B. HVAC System
01. List of Air Handling Units (AHU) with unique identification number and room description available.
02. List of AHU’s with corresponding filters, manufacturing area, return filters, ducts etc. available.
03. Availability of Air flow diagram for each air handling unit.
04. Availability of duct lay out
05. Availability of approved pressure zoning drawing
06. Availability of Area classification layout.
07. Identification & numbering of Supply air and return air grills.
08. Approved drawing for location of Supply air & return air.
09. Approved drawing indicating location for dust extraction system.
10. Availability of schedule of filter cleaning SOP.
11. Procedure of filter cleaning is as per SOP
12. Cleanliness & orderliness of filter cleaning area monitored.
13. Filter cleaning record.
14. Procedure on cleaning of primary & secondary filters.
15. Procedure on closed transportation of the filter to the filter cleaning area
16. Storage & transportation of the cleaned filter to the processing area
17. Procedure and defined criteria for replacement of primary & secondary filters
18. Procedure on handling rejected filters and filter destruction record available.
19. Availability of stand by primary & secondary filters
20. Procedure for installation of HEPA filters
21. Availability of list of HEPA filters installed and their effective area
22. Integrity test reports for HEPA filters as part of routine monitoring
23. Procedure and defined criteria for replacement of HEPA filters
24. Procedure for monitoring of Air velocity below the HEPA filter and at working height
25. Documents for air flow pattern in the area
26. Drawing & procedure for air sampling available.
27. Availability of preventive maintenance schedule.
28. Calibration record for all measuring and monitoring devices installed in the AHU available
29. Validation for establishment of recovery time & restoration time of the manufacturing area.
30. Procedure for particle count test and its records.
C. Purified Water System
01. Availability of testing procedure / specification of water
02. Availability of approved schematic diagram of water treatment plant.
03. Is source of water identified and labeled
04. All sampling locations are identified and numbered.
05. Procedure on water system sanitization records.
06. Water system sanitisation record available.
07. Procedure for cleaning of water system / water storage tank record
08. All valves, columns, pipelines identified and marked.
09. Marking of direction of water flow wherever applicable.
10. Cleanliness of the water system and its surroundings done, frequently.
11. Leakages, rusts, damages in the pipes, columns, tanks of purified water system how handled.
12. Slop of the horizontal pipelines. Determined procedure.
13. Procedure for regeneration of the Softner unit & its records.
14. Procedure for UV tubes intensity checks and its records.
15. Defined criteria for replacement of UV tubes.
16. UV burning hour records available.
17. Calibrated in line conductivity and flow meters available.
18. Procedure for cleaning of purified water storage tank. Records available.
19. Calibration record for UV hour meter available.
20. Integrity test report for vent filter and its porosity record available.
21. All user points of the purified water loop system identified and numbered.
22. Procedure for sanitizations of purified water loop system available.
23. Updated diagram of the purified water generation and distribution system including all system components, sampling points and user points available.
24. Diagram indication purified water re circulation available.
25. Material of construction used for build up of distribution line (loop system) with relevant certificates and records available procedure.
26. Results and record of all physical & chemical tests performed on water available.
27. Results and record of all microbial tests performed on water available.
28. In case of results out of established limit is an investigation performed to evaluate the cause.
29. Records of corrective and preventive action taken in relation to the causes identified for out of specification available (if any)
30. Records of preventive maintenance / any maintenance performed on the component of purified water system available.
31. Records on the changing of the filtrating means and its sanitization available.
32. Updated purified water system logbook with records of cleaning and sanitization available.
33. Resin replacement / addition record available.
34. Passivation record for purified water loop system available procedure.
35. Trend data of Physical, chemical & microbiological test results with defined alert & action limit available.
36. Procedure for sampling of purified water and validity of the procedure available.
Annexure VIII: Self Inspection Checklist for Production Department
A. General
01. Is there a production planning or production order for each product and batch size to be manufactured.
02. Production area consists of sufficient space to carryout the activity.
03. Dose design of the production area allows the effective cleaning and maintenance to avoid cross contamination and adverse effect on the quality of the product
04. Illumination level in the manufacturing area is appropriate to the activities performed.
05. Floor, wall, ceiling, joints coved with a easily washable material and free from cracks and peel off.
6. List of authorized personnel for each critical activity is available
07. Job responsibility is assigned to the personnel working the department
08. Departmental organogram is available.
09. The personnel engaged in the manufacturing activity are qualified, trained and experienced.
10. Maintenance and repair operation of the equipment in the production areas performed in a way to avoid any risk to the quality, safety, integrity of the product.
11. Entry in the production area is restricted to authorize personnel only. List of authorized persons available
12. SOP’s for the related activities are made available at the site of actual operation.
13. Machine log books, environmental control records, cleaning record etc. are stored and maintained as defined in the SOP.
14. FBD bags are inspected at regular intervals and the damaged bags are discarded. Records available
15. Inspection of the screen / sieves are carried out as per SOP and record are available.
16. Calibrated weights are available for verification of the weighing balances.
17. Calibrated measuring devices are available.
18. Drain is of adequate size and designed to prevent back-siphonage. Sanitization record available
19. All the gauges, sensors, measuring devices are calibrated.
20. Dies / punches are inspected routinely and record for rejection and destruction is available
21. Quality of the lubricants / cleaning agent used for cleaning / lubrication of the punches and its relevant record available.
22. Extinguisher provided in the area is within its validity period
23. Shoe / sleepers are cleaned and cleaning record is available
24. Dedicated & segregated area for storage of dispensed materials, intermediates, under test and approved material available
25. Cleaning and sanitization schedule followed.
26. Dispensed materials, intermediates, under test and approved products are stored off the floor on clean SS pallet and suitably spaced.
27. Access to Quarantine area is restricted to Authorise personnel only. List of authorized person available.
28. Yield of batch is monitored at each critical processing phases and deviations are investigated.
29. Availability of preparation / consumption / destruction record for cleaning & sanitizing agent solution available.
B. Entry To Manufacturing Area
01. Cleanliness of the change room is ok
02. Availability of secondary garments in the change room available.
03. Availability of disinfectant solution in the change room available
04. Disinfectant solution preparation record available
05. Cleanliness of the corridor leading to manufacturing area ok.
06. Personnel entering manufacturing area are follows the SOP on “________________”
07. Wall, floor, ceiling of the change room and the area leading to the manufacturing area is smooth, clean and free from cracks, leaks and peeling of paints and joints are coved.
08. Door interlocking system is working properly.
09. SOP’s displayed are of current version and is followed without any deviation.
C. Granulation Area
01. Status label of the area available.
02. Pressure differential and environmental condition monitored.
03. Identification tag on each equipment / instrument of the area available.
04. Equipment / instrument is duly labeled with status.
05. Cleaning record for the equipment / area available.
06. Equipment usage logbooks are maintained in accordance with the relevant SOP.
07. Raw material dispensed are duly labeled and dispensed in double poly bag and stored in a labeled container.
08. Poly bags used for the storage of materials are of food grade quality.
09. Calibration status of various monitoring and measuring devices used available.
10. Cleaning record for the equipment / instrument available.
11. Equipment preventive maintenance done according to the approved schedule.
12. Product dedicated FBD bags are used.
13. Integrity of the sieve / mesh used for sifting & sizing of the raw materials / granules are physically verified.
14. Duly approved batch manufacturing record for the manufacturing of the batch available.
15. Procedure given in the BMR is followed for the manufacturing of the product without any deviation.
16. Containers holding the intermediate product is duly labeled.
17. Removable parts / fixtures of the machines, terminal filters, return air risers are fitted properly.
18. Filter cleaning record of the area available.
19. Usage of weighing balances within its operating range. Balance verification done.
20. Equipment / instruments are operated in accordance with the relevant SOP.
21. Check the history card of the major equipment .
22. Door interlocking system is working properly.
23. Glass, glass like material, stapler pins and such type of materials are not available in the manufacturing area.
24. Personnel working in the manufacturing area follows the gowning procedure properly.
25. BMR is filled on line with all relevant details & signature of the authorized person with date.
26. Identity and weights of dispensed materials are counter checked prior to starting the manufacturing activity.
27. Deviation are noted down in BMR and approved by Head QA after investigation.
28. Area clearance has been obtained from QA prior to start manufacturing activity.
29. Area clearance record available.
30. Waste bins are covered with fresh poly bag and is free from any product residue.
31. Remnants of previous product / batch is removed from the area
32. Sanitisation of the area is carried out according to the schedule and the records are available.
33. Intermediate product containers, HDPE containers are cleaned and dried according to the SOP prior to use.
34. Waste material / reject generated during processing of the batch is handled according to the SOP.
35. Drain points are clean and sanitized according to the schedule.
36. In process tests are performed according to the frequencies mentioned in BMR.
37. Approved validation protocols are available for ongoing process validation activity. (If any)
D. Compression
01. Status label of the area available.
02. Pressure differential and environmental condition monitored.
03. Pressure differential and environmental condition record available.
04. Identification tag on each equipment / instrument available.
05. Equipment / instrument is duly labeled for particular activity.
06. Cleaning record for the equipment available.
07. Equipment usage logbooks are maintained in accordance with the relevant SOP.
08. Approved status of the granules ensured before use.
09. Calibration status of monitoring and measuring devices available.
10. Cleaning record for the equipment / instrument available.
11. Equipment preventive maintenance done according to the approved schedule.
12. Product dedicated punches are used. Records maintained.
13. Duly approved Batch Manufacturing Record is available for the manufacturing of the batch.
14. Procedure given in the BMR is followed for the manufacturing of the product without any deviation.
15. Containers holding the intermediate product is duly labeled.
16. Removable parts / fixtures of the machines, terminal filters, return air risers are fitted properly.
17. Filter cleaning record of the area available.
18. Usage of weighing balances within its operating range. Balance verification record available.
19. Equipment / instruments are operated in accordance with the relevant SOP.
20. Equipment / instruments are cleaned in accordance with the relevant SOP.
21. Door interlocking system is working properly.
22. Glass, glass like material, stapler pins and such type of materials are not available in the area.
23. Personnel working in the manufacturing area follows the gowning procedure properly.
24. Batch manufacturing record is filled on line with all relevant details & signature of the authorized person with date.
25. Deviations are noted down in BMR and approved by Head QA after investigation.
26. Area clearance has been obtained from QA prior to starting any manufacturing activity.
27. Area clearance record available.
28. Waste bins are covered with fresh poly bag and is free from any product residue.
29. Remnants of previous product / batch is removed from the area
30. Sanitization of the area is carried out according to the schedule and the records are available.
31. Intermediate product containers, HDPE containers are cleaned and dried according to the SOP prior to use.
32. Waste material / reject generated during processing of the batch Is handled according to the SOP.
33. In process tests are performed according to the frequencies mentioned in BMR.
34. Approved validation protocols are available for ongoing process validation activity (if any).
35. Metal detector efficacy performed and its record available
E. Coating Area
01. Status label of the area available.
02. Pressure differential and environmental condition monitored.
03. Pressure differential and environmental condition record available.
04. Identification tag on each equipment / instrument available.
05. Equipment / instrument of the area is duly labeled for particular activity.
06. Cleaning record for the equipment available.
07. Equipment usage logbooks are maintained in accordance with the relevant SOP.
08. Raw material dispensed for coating are duly labeled and dispensed in double poly bag and stored in a labeled container.
09. Poly bag used for the storage of materials is of food grade quality.
10. Calibration status of various monitoring and measuring devices used are available.
11. Cleaning record for the equipment / instrument are available.
12. Equipment preventive maintenance done according to the approved schedule.
13. Availability of duly approved batch manufacturing record for the manufacturing of the batch available
14. Procedure given in the BMR is followed for the manufacturing of the product without any deviation.
15. Containers holding the intermediate product is duly labeled.
16. Removable parts / fixtures of the machines, terminal filters return air risers are fitted properly.
17. Filter cleaning record of the area available.
18. Weighing balances are used within its operating range. Balance verification done
19. Equipment / instruments are operated in accordance with the relevant SOP.
20. Equipment / instruments are cleaned in accordance with the relevant SOP.
21. Door interlocking system is working properly.
22. Glass, glass like material, stapler pins and such type of materials are not available in the manufacturing area.
23. Check that personnel working in the manufacturing area are following the gowning procedure properly.
24. BMR is filled on line with all relevant details & signature of the authorized person with date.
25. Identity and weights of dispensed materials are counter checked.
26. Deviations are noted down in BMR and approved by Head QA after investigation.
27. Area clearance has been obtained from QA prior to starting manufacturing activity.
28. Area clearance record available.
29. Waste bins are covered with fresh poly bag and is free from any product residue.
30. Remnants of previous product/ batch is removed from the area
31. Sanitization of the area is carried out according to the schedule and the records are available.
32. Intermediate product containers, HDPE containers are cleaned & dried according to the SOP prior to use.
33. Waste material / reject generated during processing of the batch is handled according to the SOP.
34. Drain points are clean and sanitized according to the schedule.
35. In process tests are performed according to the frequencies mentioned in BMR.
36. Approved validation protocols are available for ongoing process validation activity (if any)
Any other observation:
Annexure IX: Self Inspection Checklist for Packing Department
A. General
01. Is There a production planning or production order for each product and batch size to be packed.
02. Procedure for effective cleaning and maintenance to avoid cross contamination.
03. Illumination level in the packing area is appropriate for the activities performed.
04. Floor, wall, ceiling, joints coved with a easily washable material and free from cracks and peel off.
05. List of authorized personnel for each critical activity is available
06. Job responsibility for personnel working in the department available.
07. Departmental organogram available.
08. Personnel engaged in the packing activity are qualified and trained.
09. Preventive maintenance for the equipment done as per schedule.
10. Entry in the packing area is restricted to authorized personnel only.
11. Machine logbooks, environmental control records, cleaning record etc. are stored and maintained as defined in the SOP.
12. Calibration record for the measuring devices are stored and maintained as defined in the SOP.
13. Machine change parts are stored properly
14. Calibrated weights are available for verification of the weighing balances. Records available.
15. Calibrated measuring devices are available.
16. All the gauges, sensors, measuring devices are calibrated and its record is available.
17. Verify of approved packing materials prior to starting packing activity.
18. Extinguisher provided in the area and is within its validity period
19. Availability & maintaining of cleaning sanitizing schedule followed.
20. Adequate system for handling mix-up of packing materials.
21. Packing material return record available.
22. Procedure on handling of online rejection of packing materials available.
B. Primary Packing Area
01. Status label of the area available.
02. Pressure differential and environmental condition monitored.
03. Pressure differential and environmental condition record.
04. Identification tag on each equipment / instrument of the area available.
05. Equipment / instrument is duly labeled.
06. Cleaning record for the equipment /area
07. Equipment usage logbooks are maintained in accordance with the relevant SOP.
08. Verification of Identity of packing materials with BPR and Product to be packed done.
09. Calibration status of various monitoring and measuring devices used available.
10. Cleaning record for the equipment / instrument available.
11. Equipment are maintained according to the approved schedule.
12. Duly approved Batch Packing Record for packaging activity available.
13. Procedure given in the BPR is followed for the packing of the product without any deviation.
14. Containers holding the product to be packed are approved and duly labeled.
15. Removable parts / fixtures of the machines, terminal filters, return air risers are fitted properly.
16. Filter cleaning record of the area available.
17. Usage of weighing balances within its operating range. Calibration tag available.
18. All the equipment / instruments are cleaned in accordance with the relevant SOP.
19. Glass, glass lime material, stapler pins and such type of material are not available in the primary packing area.
20. Personnel working in the area follows the gowning procedure properly.
21. Batch Packing Record Is filled on line with all relevant details & signature.
22. Area clearance has been obtained from QA prior to starting packing activity.
23. Area clearance record available.
24. Remnants of previous product / batch is removed from the area
25. Sanitization of the area is carried out according to the schedule and the records are available.
26. Waste material / reject generated during processing of the batch is handled according to the SOP.
27. In process tests are performed according to the frequencies mentioned in BPR.
28. Approval of overprinted / embossed batch coding details taken prior to start the packing activity.
29. Attachment of primary packing material specimen with the batch packing record done.
C. Labeling
01. Issued labels are stored under lock and key.
02. Access to the labels allowed only to the authorized personnel. List of authorized person available.
03. Label issue record for coding of batch details done.
04. Issue record for over coded labels to the packaging lines available.
05. Reconciliation of the labels and other packing material done.
06. Is excess coded labels being allowed to return back to stores or shredded.
D. Stereo Control
01. Stereo stored under lock and key.
02. Access to the stereo allowed only to the authorized personnel. List of authorize person available.
03. Verification of stereos for conformity with the EPO / specification at the time of receipt of the same done.
04. Stereo receipt & issue record for coding of batch details available.
05. Retrieval record for stereos issued for coding available.
06. Reconciliation of the stereos.
07. Destruction of used stereos available.
08. Usage of cut stereos done.
E. Issue and Return of Packing Materials
01. Storage of the issued primary secondary packing materials in accordance with the SOP.
F. Secondary Packing Area
01. Status label on packing lines available.
02. Physical segregation of the each packing lines done.
03. Environmental monitoring and its record available.
04. Identification tag on each equipment / instrument of the area available.
05. Equipment / instrument is duly labeled with its status label.
06. Cleaning record for the equipment / area available.
07. Equipment usage logbooks are maintained in accordance with the relevant SOP. Records available
08. Verification of identity of secondary packing materials with BPR and product to be packed done.
09. Calibration status of various monitoring and measuring devices used available. Calibration tag available.
10. Cleaning record for the equipment / instrument available.
11. Equipment preventive maintenance done as per approved schedule.
12. Duly approved batch packing record for packaging activity available.
13. Procedure given in the BPR is followed for the packing of the product without any deviation.
14. Availability of duly labeled rejection bins and waste bins.
15. Removable parts / fixtures of the machines, supply air grill are fitted properly.
16. Filter cleaning record of the area available.
17. Usage of weighing balances within its operating range. Balance verification record available.
18. All the equipment / instruments are operated in accordance with the relevant SOP.
19. All the equipment / instruments are cleaned in accordance with the relevant SOP.
20. Personnel working in the area follows the gowning procedure properly..
21. Batch packing record is filled on line with all relevant details & signature of the authorized person with date.
22. Deviations from the established system, procedure, BPR are identified, investigated, approved by Head QA and recorded in the BPR.
23. Area clearance has been obtained from QA prior to starting packing activity.
24. Area clearance record for each stage of packing done.
25. Remnants of previous product / batch is removed from the area
26. Cleaning & sanitization of the area is carried out according to the schedule and the records are available. (if any)
27. Storage of secondary packing material on packing lines
28. Waste material / reject generated during processing of the batch is handled according to the SOP.
29. In process tests are performed according to the frequencies mentioned in respective BPR.
30. Approval of overprinted / embossed batch coding details prior to start of the packing activity done.
31. Attachment of secondary packing material specimen & approved specimen with the batch packing record done.
32. On line reconciliation of printed packing materials done.
33. Material packed stored on the pallets.
Any other observation:
Annexure X: Self Inspection Checklist for Warehouse
A. General
01. Illumination level in the area is appropriate to the activities performed.
02. Floor, wall, ceiling, joints are free from cracks and peel off corners are caved for easy cleaning.
03. List of authorized personnel for each critical activity is available
04. Job responsibility is assigned to each and every personnel working in the department
05. Departmental organogram is available
06. Personnel working are qualified and trained.
07. Entry in the warehouse is restricted to authorize personnel only. List of the authorized persons available
08. SOP related to the activities performed are available . List of SOP available.
09. Machine logbooks, environmental control records, cleaning record etc. are stored and maintained as defined in the SOP.
10. Calibration record for measuring devices are stored and maintained as defined in the SOP.
11. Calibrated weights are available for verification of the weighing balances. Balance calibration and validation records available.
12. Calibrated measuring devices are available.
13. All the gauges & measuring devices are calibrated and its record are available.
14. Under test and approved materials are duly labeled and physically segregated.
15. Extinguisher provided in the area is within its validity period
16. Dedicated & segregated area for storage of quarantined, under test and approved material
17. Availability & maintaining of cleaning sanitizing schedule.
18. Material are stored off the floor on clean pallet and suitably spaced.
19. Availability of preparation / consumption / destruction record for cleaning & sanitizing agent solution.
20. Cleaning devices, brooms are kept in the dedicated area, off the floor and away from wall.
21. Temperature mapping reports for the area available.
22. Availability of separate area for storage of rejected materials
23. Availability of list of approved vendors
24. Availability of material location index
25. Procedure for status labeling of the materials
26. List for storage condition for all materials
27. Training record for personnel with assigned job responsibilities
28. Filter cleaning schedule and its report
29. Cleaning and sanitizing schedule and its records.
B. Unloading / Receiving Bay
01. Shutter working in proper condition to ensure proper opening and closing.
02. Closure and opening of the receiving bay
03. Vacuum cleaner for cleaning of containers received is in working condition.
04. Marked space for keeping vacuum cleaner with SOP for operation and cleaning
05. Vacuum cleaner cleaning record
06. Balance calibration and verification record available.
07. Calibrated weights are used for balance verification
08. Register for entry of incoming materials is updated.
09. Check list for documents to be received along with the consignment
10. Procedure for handling of damaged containers on receipt
C. Raw Material Storage Area
01. Calibrated Thermo hygrometer available. Calibration certificate available.
02. Cleaning & sanitization of warehouse area done and records maintained.
03. All the raw material labeled properly.
04. Physical segregation of the material with different status label and storage conditions
05. Storage of material off the floor on pallets away from wall.
06. Disinfectant solution preparation, consumption and destruction record available.
07. Availability of fire extinguisher within its validity period
08. Separate area for rejected and expired materials
09. Separate area for solvent storage available
10. Flame proof electric fixtures in solvent storage area
11. Dedicated solvent transfer pump for each solvent available.
12. Environmental condition of the area maintained record available.
13. Dispensing of materials in as per FIFO system done.
14. Proper sealing and labeling of sampled containers done.
15. Updated material location chart available.
16. Procedure for handling of incidents such as spillage, fire etc. available
17. Validation of software programme used for receipt, issue and control of materials done.
18. Separate marked area for storage of quarantined, under test, approved onder hold materials available.
D. sampling
01. Dedicated room for sampling of Raw materials available.
02. Gowning and degowning procedure for entry and exit in and from sampling area available.
03. Pressure differential and environmental condition record of the sampling area maintained.
04. RLAF Qualification as per schedule.
05. Cleaning and sanitizing of sampling area, sampling booth and its record maintained.
06. Calibrated weighing balances with its operating range available.
07. Sampling logbook available.
08. RLAF filter cleaning record available.
09. Dedicated vacuum cleaner for cleaning sampling booth available.
10. Calibrated magnehaulic gauges Available.
11. Availability of previously cleaned and numbered sampling tools available.
12. Sampling tools usage and cleaning record available and updated.
13. Marked working zone and working heights inside the sampling booth done.
14. Train person for dispensing of sample available. Training Record.
15. List of sample quantity and copy of sampling SOP available
16. Storage of sampling tolls done properly.
17. Cleaning and labeling of sample storage containers / poly bag done.
18. Procedure for preparation of composite sample and number of container to be sampled available.
19. Labelling of sampled containers and proper sealing of the containers done
20. Cleaning validation status of sampling tools available.
21. Dedicated sampling tools for sampling of solvents available.
22. Storage and preservation of the samples
23. Records for Air Flow visualization pattern available
24. Removable parts / fixtures of the sampling booth, filter grill, return sir risers are fitted properly.
25. Glass, glass like materials, stapler pins, knife (Grade _SS_) are not available in the sampling area.
E. Dispensing
01. Gowning and de gowning procedure for entry in to dispensing area available.
02. Pressure differential and environmental condition record of the dispensing area Maintained.
03. Qualification of dispensing booths done.
04. Cleaning and sanitizing of dispensing area, dispensing booth and its record Maintained.
05. Calibrated weighing balances with its operating range available.
06. Dispensing logbook updated.
07. RLAF filter cleaning record available.
08. Dedicated vacuum cleaner for cleaning dispensing booth
09. Calibrated magnehaulic gauges available.
10. Availability of previously cleaned and numbered dispensing tools available.
11. Dispensing tools usage and cleaning record available.
12. Marked working zone and working heights inside the dispensing booth done.
13. Train personnel for dispensing of materials available. Training record.
14. Material dispensed is counter check by the production personnel or qa person
15. Authorised BMR for individual product / batch available
16. Area clearance prior to starting dispensing activity.
17. Storage of tools used for dispensing done properly.
18. Cleaning and labeling of containers / poly bag done. SOP available.
19. Labelling of dispensed containers and proper closure of the containers
20. Dispensing of the material on FIFO basis done..
21. Cleaning validation status of dispensing tools available / tools dedicated.
22. Cleaning of dispensing tools and containers.
23. Dedicated solvent transfer pumps for dispensing of solvents available.
24. Approved status of the materials checked prior to dispensing
25. Waste bins are covered with the fresh poly bag and is free from residue of materials
26. During Dispensing, opening and closing of containers done in side the working zone of dispensing booth
27. Verification of the Item code and quantity of the material with BMR at the time of dispensing done.
28. Pattern of dispensing API at the end of the dispensing operation is followed
29. Procedure for transportation of the containers with dispensed materials to the manufacturing area
30. Cross contamination prevention measures during dispensing operation. SOP available
31. Cleaning of containers prior to transfer to the dispensing area done
32. Counter verification of dispensing operation done.
33. Removable parts / fixtures of the dispensing booth, filter grill, return air risers are fitted properly.
34. Glass, glass like materials, stapler pins, knife (grade__SS__) are not available in the dispensing area
35. Dedicated material transfer trolley for dispensing area available
36. Man and material movement flow diagram available.
37. Man entry segregated from material entry.
Any other observation:
Annexure-XI: Non-Conformance Report
Department Audited:
Date
Section Name
Targeted Area
Name of auditor
Person responsible for job:
Details of Non conformance observed
Sr. No.
Details of Non Conformance observed
Reason for NCR
Corrective Action
TCD
Compliance Status
Verified By / Date
Reviewed by QA Head:
Date
Non-Conformance Report
Department Audited:
Date:
Details of Non Conformance Observed:
Auditor (Sign / Date)
Reason for NCR:
Corrective Action Taken:
Target Completion Date (if Any):
Preventive Action:
Compliance Status:
Verified By (Sign / Date)
Closure:
Head QA (Sign / Date)