SOP for Documentation and Data Control in the pharmaceutical manufacturing facility
1.0 OBJECTIVE:
To lay down the procedure for Documentation and Data Control procedure for Preparation of documents, issuance, receipt, retrieval, storage, retention and destruction of documents.
2.0 SCOPE:
The Standard Operating Procedure (SOP) is applicable for Documentation and Data control for Preparation of Masters, receipt, issuance, retrieval, storage, retention and destruction of documents in Quality Assurance (QA) department at [Company name].
3.0 RESPONSIBILITY:
3.1 All department personnel
3.1.1 Submitting the completed documents related to their functional area in QA department.
3.1.2 To handle the respective issued documents under their custody.
3.2 Documentation management personnel (QA department): To ensure proper Receipt, Issuance, storage, retrieval, retention and destruction of all documents & Management of Documentation Cell.
3.3 Head QA: To ensure compliance of this SOP.
4.0 PROCEDURE:
4.1 Master Documents:
4.1.1 The documents received from Corporate Quality Assurance (CQA), R & D, Regulatory or other manufacturing locations. i.e. Master Manufacturing Document/ Master Formula Record, Technical Manufacturing Document/ Development Report, Bill of Material, Technical Analytical Document/ Analytical Methods, General Test Procedures (GTPs) etc. shall be made master by stamping “MASTER COPY” in Green Color on Top Center on each page of the document along with sign and date in black color pen only.
4.1.2 The documents generated at the manufacturing location [Company Name and Location] like Batch Manufacturing Record (BMR), Batch Packing record (BPR), Standard Operating Procedure (SOP), SOP Master List, Standard Cleaning Procedure (SCP), SCP Master List, Validation Protocols, Site Master File (SMF), Validation Master Plan (VMP), Quality Manual, Worksheet for Analysis, Approved Vendor List shall be made master by affixing Master Copy Stamp in Green Color with sign and date in the respective document with Blue Pen only.
4.1.3 The documents such as Calibration certificates shall be submitted to QA documentation by engineering department after verifying and putting stamp of “Checked By / Date” in Violet color ink with sign / date in blue color pen only on each page of document.
4.1.4 Informative documents like Corporate Guidelines, Good Laboratory Practices (GLP) Manuals etc. shall be used for reference purpose only. These documents are not required to be made masters, issued, retrieved and shall be stored in Quality Assurance department.
4.1.5 Whenever any documents made as master document the previous or supersedes master document (if any) shall be made obsolete by stamping “Obsolete for Reference Only” in red color ink on center of page diagonally across the text on each page.
4.1.5.1 Obsolete documents shall be maintained as per applicable storage period.
4.2 Issuance of Documents as controlled copy
4.2.1 The documentation cell person issue the documents by taking photocopy of master documents documents in required number and stamping with the stamp “CONTROLLED WHEN IN RED” in red color on each page of the document on Right Top Corner and record the necessary issuance entries in “Receipt, Issuance, Retrieval and Destruction of Document Record Register”.
4.2.2 The Documentation Cell Personnel shall issue the document like worksheet for Record of Analysis to QC /IPQA, calibration worksheets to QC / IPQA as per current version of SOP on Procedure for Preparation, Approval, Control and Issuance of Worksheet for Record of analysis.
4.2.3 The Documentation Cell Personnel shall issue the Standard Operating Procedures (SOP) as per procedure mentioned in current version of SOP on “Preparation, Approval, Issue and Control of Standard Operating Procedure”.
4.2.4 The Standard Cleaning Procedure (SCP) shall be issued as per procedure mentioned in current version of SOP on “Preparation, Approval and Control of Standard Cleaning Procedures for Equipment”.
4.2.5 The Documentation Cell Personnel shall issue the photocopy of Process Validation/ Cleaning Validation / Analytical method validation/ Hold Time studies Protocol by stamping on required photocopy’s first page of the protocol with following details duly filled by black pen only. “issued by / Date, issued to, user copy no” in violet color ink stamp on Left Top Corner.
4.2.6. All the pages of photocopies of the protocol shall be stamped as “CONTROLLED WHEN IN RED” in red color ink on top right corner of each page and record the details of issuance of the same by entering the details as per format “General Documents Issuance Record Register”.
Note: In some cases protocol shall be issued to concerned departments for reference purpose only. After completion of the study, except actual executed protocol all other reference protocol shall be subjected to shredding. Any backup data generated shall be affixed on a separate sheet which shall be kept and complied with actual executed protocol.
4.2.7 The documents like calibration certificates shall be issued by taking photocopy from the original verified copy and putting stamp “QA Issued” in red color on top right corner of all pages of photocopy with prior permission of QA Head.
4.2.8 SOP and SCP master list shall be issued by stamping “ISSUED BY / DATE, ISSUED TO, USER COPY NO” in violet color ink stamp on Left Top Corner on each page and entering details in it with black pen only and record the same.
4.2.9 Whenever protocols printed on [Company Name] logo paper and signed with blue pen as a master and need to execute the same are not required to issue as a control one. Here the master copies itself a control copy. Eg. Qualification protocols.
4.2.10 Informative documents such as request, checklists, training calendar / questionnaires, calibration / validation schedules, training schedule etc. are not required to be controlled unless otherwise if required.
4.3 Issuance of Log Books and Registers
4.3.1 All the logbooks and register existing in the plant shall be controlled by Quality Assurance department (Documentation Cell Personnel).
4.3.2 Documentation Cell Personnel shall paste the sticker label as per applicable format on inner side of the cover page of the logbook or register and fill the details with black pen and stamp the sticker label as “CONTROLLED WHEN IN RED” in red color ink only.
4.3.3 At the same time of issuance, all the necessary entries shall be made in register “Issuance & Retrieval Controlled Logbooks or Register”, which shall be, maintained department wise.
4.4 Preparation and Issuance of Formats except Logbook or Register
4.4.1 Routine formats such as Daily Cleaning Records, Daily Temperature and Relative Humidity Monitoring Records, Sequential logs, and yield calculation sheet etc. shall be prepared as per example format or in logbooks form only.
4.4.2 Routine formats shall be in the form of bonded books or logbooks only. Individual department shall be responsible for processing and procuring the formats, books belonging to their respective departments.
4.4.3 User department shall handover supersedes log books of format to Documentation Cell Personnel at the time of new issuance.
Note: In case of old logbooks which are not completed at the time of issuance of new one, are to be submitted to Documentation Cell after completing it.
4.4.4 Documentation Cell Personnel shall issue the log books as per procedure detailed under the title of Issuance of Logbooks or Register and make the necessary entries in respective format.
4.4.5 In case, if any loose format if required to be controlled then on request to QA Head by written communication, Document cell personnel shall issue the same as controlled copy by putting controlled when in red stamp and putting sign and date in black ink only.
4.4.6 Make the necessary entries as per applicable format.
4.5 Issuance of Uncontrolled Documents
4.5.1 When any documents are to be issued to outside agency or other location, or need based, such documents shall be issued by taking photocopy in required number after taking prior written/ verbal permission from Head QA or his Designee.
4.5.2 Each page of the photocopy shall be stamped as “UNCONTROLLED COPY, NOT FOR OPERATIONAL USE” in green color ink on right bottom corner of each page.
4.5.3 On first page of the document, Head QA or his Designee shall enter sign / date in black ink near the stamp.
4.5.4 The record of such issuance shall be maintained as in format “ISSUANCE OF UNCONTROLLED COPY” as per respective format.
4.6 Issuance of Duplicate Copy
4.6.1 In case of issuance of duplicate copy due to no readability (due to spillage), wear and tear etc. of copies, the duplicate copy shall be issued after the request with proper justification which is authorized by Head QA.
4.6.2 Request for duplicate copy shall be given by filling the request form as per respective format. Additional copy shall have remark as additional copy – 1, 2, and so on.
4.7 Preparation and Issuance of list
4.7.1 The various list like list of instruments, equipment, List of Technical Person, List of Drawings, SOP/ SCP master list and any other required list shall be available with QA department in the Master Form for controlling.
The list shall be prepared in the format as per respective format.
4.7.2 The list shall be made master by putting sign and date with blue ink only.
4.7.3 The master list then shall be submitted to QA for controlling.
4.7.4 The Documentation Cell Personnel shall take the required number of photocopies of the respective master list and stamp it with “CONTROLLED WHEN IN RED” only by putting sign / date on it with black pen only in the center of the stamp and writing “Copy x of y” where ‘x’ is the serial number of copy and ‘y’ is the total number of copies to be issued.
4.7.5 Whenever there is a revision required, in the list the respective departments shall take a printout of new list and put sign and date in blue ink only.
4.7.6 Along with the new list, the respective department personnel shall submit the controlled copy of previous master list also.
4.7.7 The retrieved controlled copy of list shall be subjected to shredding by QA personnel and master supersedes shall be stamped as “OBSOLETE FOR REFERENCE ONLY”.
4.7.8 Each time the list shall be numbered for its revision. For 1st time the revision number will be “00” & than after 01, 02, 03, … and so on.
4.8 Retrieval of Controlled Documents
4.8.1 All the documents, which are issued as controlled documents, shall be retrieved on issuance of revised version of controlled documents simultaneously and record the details of the same.
4.8.2 Such retrieved documents shall be destroyed by shredding after recording their retrieval entries in their respective logbooks.
4.8.3 Destruction record of such shall be maintained in respective formats.
4.9 Storage of Master Documents
4.9.1 All the master documents, which shall be needed for the routine use, shall be stored in closed document storage cabinet of Quality Assurance Department under lock and key.
4.9.2 All other master documents, which are not required for routine use, shall be stored in documentation cell under lock and key.
4.10 Receipt of Completed Documents (BMR/ BPR/ logbook/ protocol worksheets)
4.10.1 All the completed documents of the respective departments shall be submitted to Quality Assurance Department.
4.10.2 All the completed documents shall be stored in the documentation cell of Quality Assurance Department.
4.10.3 The documents shall be placed in the documentation cell by allocating specific document number system as under:
e.g. RBXX-YY
Where:
R : Rack
B : Rack No. (for rack no. 1 than for 2, 3, 4 ….. it will be B, C, D……)
XX : Shelf No. (i.e. 01, 02, 03, 04…..) from top to bottom.
YY : Document Serial No. for that particular shelf
4.10.4 Documents in Documentation cell shall be stored as per the numbering system.
4.10.5 If the requirement of document arises which is submitted in Quality Assurance Department for reference purpose, then the respective department shall fill the respective format, and take authorization from head QA/ Designee and then submitted to Documentation Cell Personnel.
4.10.5.1 After that Documentation cell personnel shall provide the required document after making the required entries in” Document Movement Register” as per respective format .
4.11 Retention period for documents.
4.11.1 All the documents master, controlled and retrieved documents shall be stored for a desired period of time only.
4.11.2 The documents shall be stored for the period as per respective format.
4.11.3 All the batch records submitted to the document cell shall be recognize with its minimum retention period by sticking label as per respective format.
4.11.4 The Documentation Cell Personnel shall enter minimum retention time (Month & Year) on each batch record.
Note: This SOP supersedes all previous retention time indicated on each documents and shall be considered void.
4.12 Destruction of Documents
4.12.1 All the documents whose retention period is over, shall be destroyed after authorization from Head QA then after by shredding so as destroy the complete identity of document.
4.12.2 The details of the destruction shall be recorded in the respective control register of completed documents.
4.12.3 Review for destruction to be carried out in the month of January of every year in accordance with the respective format and a list of all the documents shall be which are to be destroyed in that year.
4.13 Controls on Computerized Data
Note:
• All the stamps used in making master document and controlling of records shall be always kept in lock & key in QA department.
• Access to those stamps shall be limited to authorized persons only.
• The documents that are to be produced to auditors shall be either controlled copies or master copies.
• The shortfalls to the master documents such as SMF / VMP / Quality Manuals etc. shall be added in the form of addendum (attachments).
4.14 General Precautions
4.14.1 Hand written entries must be legible and dark enough to photocopy clearly.
4.14.2 Every letter and number should be clear and readable to someone other than the originator.
4.14.3 All hand written entries must be made using indelible ink only.
4.14.4 Erasable ink, non-waterproof ink, correction fluid are not permitted.
4.14.5 All entries and correction must be signed or initialed and dated at the time of the correction as per the current version of SOP on “Correction of Documentation Errors”
4.14.6 Predating and postdating entries is prohibited.
4.14.7 Record notes and comments directly on records. Do not record information on a separate piece of paper and enter on the record later.
4.14.8 Photocopies and reproduction of controlled documents shall be done prior permission from Head QA / designee.
4.14.9 Handwritten correction on documents must never erase or obscure the original information.
5.0 ANNEXURES:
Annexure – I : Receipt, Issuance, Retrieval and Destruction of Document Record Register
Annexure – II: General Documents Issuance Record Register
Annexure – III: Issuance of Uncontrolled Copy
Annexure – IV: Format label for Register / Logbooks control
Annexure – V: Issuance and Retrieval Controlled of Logbooks or Register
Annexure – VI: Example for Preparation of Preprinted Formats
Annexure – VII: Request for Issuance of Duplicate Copy
Annexure – VIII: Format for the List
Annexure – IX: List of Retentions Period of the Documents
Annexure – X: Label Specimen for Retention Period
Annexure – XI: Specimen Stamps
Annexure – XII: Issuance, Retrieval and Destruction of SOP/SCP Index
Annexure – XIII: List of Hard Copy Of Obsolete Master Documents To Be Destruction After Preparing Soft Copy
Annexure – XIV: Issuance Record for Loose Format
Annexure – XV: Request for Issuance of Documents from Documentation Cell
Annexure – XVI: Document Movement Register
Annexure – I: Receipt, Issuance, Retrieval and Destruction of Document Record
Name of Material / Product:
Code:
Sr. No.
Document No.
Revision No.
Received By / Date
Issued By / date
Received By / Date
Controlled Copy Retrieved By / Date
Controlled Copy Destroyed By / Date
Master Obsolete By / Date
Obsolete Master
Destroyed By / Date
Remarks
Annexure – II: General Documents Issuance Record Register
Date
Nature of document
Document No.
Issued To
Issued Copy No.
Issued By / Date
Received By / Date
Annexure – III: Issuance of Uncontrolled Copy
Sr. No.
Date
Name of Document
Doc. No. (If Any)
No. of Copies
Issued To
Issued By / Date
Received By / Date
Dispatch Through (If Any)
Annexure – IV Format label for Register / Logbooks control
Title:
Format No:
Register No:
Issued By:
Controlled On:
No Of Pages : 01 To_ _
Annexure – V Issuance and Retrieval Controlled of Logbooks or Register
Date
Name of Register (Log Book)
Register No.
Issued To
Issued By / Date
Received By / Date
Complete Reg.
Retrieved By / Date
Destruction By / Date
Annexure – VI: Example for Preparation of Preprinted Formats (perforated log book)
Annexure – VII: Request for Issuance of Duplicate Copy
From:
To:
Please issue of duplicate against copy number of ________ of document ___________________ having document number________________.
Justification:
___________________
Requested by
Approved By (Department Head)
Authorised By (Head QA)
Annexure – VIII: Format for the List
Annexure – IX: List of Minimum Retention Period of Documents
Name of Documents – Minimum Retained Upto
Batch Production Control Record (BPCR)
– 05 Years or Expiry + 1 year (whichever is more)
Batch Production Control Record (BPCR) if ANDA batch
– Life Time
Raw / Packing Material Analytical Records
– 05 Years or Expiry + 1 year (whichever is more)
Raw Material and Packing Material Analytical Records incase of material used in ANDA
– Life Time
Annual Product Review
– 10 Years
Market Complaints and Product Recall Records
– 10 Years
Equipment / Instrument Usage, Cleaning and Calibration Records
– Life Time
Master Production and Control Records (MPCR)
– Life Time
Obsolete SOP and SCPs
– Immediate destruction to be done after scanning
Obsolete Master BMR / BPR / TMD / MMD
– Immediate destruction to be done after scanning
Obsolete GTPs and Specifications
– Immediate destruction to be done after scanning
Obsolete Packing Material Bill of Materials
– Immediate destruction to be done after scanning
Obsolete Approved Vendor List
– Immediate destruction to be done after scanning
Obsolete Worksheets (Record of Analysis)
– Immediate destruction to be done after scanning
Obsolete Site Master File / Validation Master Plan / Quality Mannual
– Immediate destruction to be done after scanning
Change Control / Deviation / Incident / Out of Specification
– Life Time
Internal / Regulatory / Customer Audit Records
– 10 Years
Contract Laboratory Records
– 10 Years
Completed / Discontinued QA related issuance records
– 10 years after completion
Control Sample Records (Finished Product)
– 05 years after completion or Expiry + 1 year (whichever is more)
Control Sample of Raw Material
– 06 year after expiry of material
Stability Records
– Life Time
CAPA Register
– Life Time
Media Preparation Records
– 6 years after completion
Process Validation Records
– Life Time
Validation Records (IQ / OQ / PQ)
– Upto life of Equipment / Instrument or Life Time
Master Art Work
– Immediate after obsolete
Analytical Report Numbering Register
– 06 years after completion
Tolling Inspection & Issuance Record
– 06 year after completion
Finished Product Distribution Record
Life Time
Environment condition monitoring records
– 06 year after completion
Preventive Maintenance Records and Registers
– 06 year after completion
Obsolete Engineering Records
– 06 year after completion
Annexure – X: Specimen Label for Retention Period
Annexure – XI: Specimen Stamps
Annexure – XII: Issuance, Retrieval and Destruction Record for SOP / SCP Index
Date
SOP/SCP/index of
Copy No.
Revision No.
Issued By / Date
Received By / Date
Retrieved By Sign / Date
Retrieved Copy Destructed By / Date
Master Obsolete By / Date
Annexure – XIII: List Of Hard Copy Of Obsolete Master Documents To Be Destruction After Preparing Soft Copy
Name of Master Document
Batch Manufacturing Records
Batch Packing Records
Raw Material Specifications
Packing Material Specifications
Finished product Specifications
Packing Material Bill of Materials
Tentative Manufacturing Documents
Master Manufacturing Documents
Standard Operating Procedures
Standard Cleaning Procedures
Approved Vendor List
Worksheets (Record of Analysis)
General Test Procedures
Site Master File
Validation Master Plan
Quality Manual
Annexure – XIV: Issuance Record for Loose Format
Date
Department
Title
Document / Format No.
No. of Pages Issued
Issued By / Date
Received By / Date
Complete Document Retrieved By / Date
Reason
(if any)
Annexure XV: Request for Issuance of Documents
From:
To: Documentation cell (Quality Assurance)
Please issue the following documents.
Sr. no.
Name/Detail of the document
Required For/Purpose
QA Remarks
Requested By/Date
Authorized By (Head QA)
Annexure XVI : Document Movement Register
Sr. no.
Date
Title
Requested Department
Rack No.
Issued By / Date
Received By / Date
Returned Rec. By /Date
Remark