SOP for Technology Transfer of Manufacturing Process
1.0 OBJECTIVE:
To describe the Procedure for analysing the requirements and necessary actions to be taken to effectively plan and execute a successful transfer of manufacturing process technology from transferring site to receiving.
2.0 SCOPE:
This SOP (Standard Operating Procedure) covers the procedure for transfer of technology of Manufacturing Process from R & D / one Production site to other Production site applicable at [Company name].
3.0 RESPONSIBILITY:
3.1 When [Company name] as receiving site:
3.1.1 Quality Assurance Personnel: To receive required document from R&D / transferring site and verify received document, to prepare Gap Analysis report, Co-ordinate in Technology Transfer Activity.
3.1.2 Production Personnel: To prepare Batch Manufacturing / Packaging Record as per received document, to ask assistance from R&D / Transferring site as per requirement basis, to access and fulfill any special requirement at production floor for manufacturing of formulation.
3.2 When [Company name] as transferring site:
3.2.1 Quality Assurance Personnel: To transfer required document related to product manufacturing technology.
3.2.2 Production Personnel: To provide technical assistance / training regarding technology transfer to receiving site as per requirement of receiving site.
4.0 PROCEDURE :
Definition: The systematic procedure that is followed in order to pass the documented knowledge and experience gained during development and/or commercialization to an appropriate, responsible and authorized party. This not only includes transfer of documentation but also includes the demonstration at the receiving unit to effectively carryout the critical elements of the transfer of technology.
4.1 Transfer of Manufacturing Process of dosage forms from R&D (Research and Development) / one production site to Production site of [Company name]
4.1.1 Document Requirement
Note: Requirement of Document may vary than those mentioned in Annexure I and II as the case may be and not limited to given checklist.
4.1.1.1 If the technology transfer is from R&D then receive following from R&D (Research and Development) / CQA (Corporate Quality Assurance) / PDC (Packing Development Cell) / ADL (Analytical Development Lab.) as applicable :
a. Report of Development Batch
b. Master Manufacturing Document (MMD).
c. Technical Analytical Document (TAD)
d. General Test Procedure (GTP)
e. Specification for Raw Material / Packing Material
f. Packaging instruction
g. BOM Raw Material / Packing Material
h. Vendor Dockets
Check list of received document shall be updated for respective product as per Annexure I before commencement of first batch.
4.1.1.2 If the technology transfer is from any production site then receive following from Transferring site / CQA (Corporate Quality Assurance) / PDC (Packing Development Cell) / ADL (Analytical Development Lab.) as applicable :
a. BMR / BPR / TMD
b. Specification for Raw Material / Packing Material / intermediates / Finished product
c. General Test Procedure
d. Packaging instruction
e. Stability Data
f. Vendor Information
g. List of equipment used in manufacturing
h. Storage condition requirement
i. Summary of process parameter
Check list of required document shall be updated for respective product as per Annexure II before commencement of first batch.
4.1.2 Based on above received document Site Evaluation assessment shall be done for coming new product by using Annexure III
4.1.3 Site Evaluation may be done considering below points but not limited.
4.1.3.1 Reference dosage shall be identified with which the comparison to be done.
4.1.3.2 The equipment those are currently in place shall be evaluated to ensure that the formulation process shall be comparable.
4.1.3.3 The design of the facility shall be evaluated for personnel flow, product & material flow, cleanliness zones, safety classes and support systems, HVAC system, water systems and any other applicable utility.
4.1.3.4 The evaluation must consider working principle, capacity, construction data, computer control parameters and special enhancement of equipment.
4.1.3.5 To ensure that the equipment qualifications are performed under any new parameters that might include for specified product prior to technology transfer.
4.1.3.6 Product to be transferred shall be evaluated regarding the necessity for cleaning Validation.
4.1.3.7 Assessment for any special requirement at production floor like Temperature Relative humidity, Special Lighting, any new equipment require etc. shall be done for batch to be manufactured.
4.1.4 Production / Quality Assurance person shall prepare BMR/BPR and shall be approved by QA.
4.1.5 QA personnel shall also prepare Site Evaluation and Gap analysis report and complete the required documentation by using Annexure IV for respective product
4.1.6 Based on BMR/BPR, TAD and in consultation with R&D / Production Personnel, QA personnel shall prepare protocol (Optimization / Qualification / Exhibit / Validation Batch) for manufacturing of product to be transferred.
Note: Study pattern and designing of protocol for Optimization / Qualification / Exhibit / Validation batches shall vary based on different regulatory requirement and finalized after consulting with regulatory department, R&D or by Production Head and QA Head.
4.1.7 Challenge / Validation Study shall be included in study protocols like
i. Mixing time of dry powder mix,
ii. Wet mixing time and granulation end point
iii. Mixing time of Dry Granules with lubricant and Glidant
iv. Sampling procedure and plan
v. Compression / capsule filing parameter like speed of machine
vi. Coating parameter like spray rate, distance of spraying gun, Pan RPM
4.1.8 Successful transfer of technology shall be concluded in respective protocol/ report summary.
4.1.9 On basis of the Summary report and data of above study if any changes are require, the TAD, BMR & BPR shall be revised by filling the Change Control Form (CCF).
4.1.10 According to the above Summary report, the commercial production batches shall proceed.
4.1.11 In case of multiple strength and formulation is linear or process parameter are same, limited challenge study shall be performed for identical parameter and shall be concluded based on study done.
4.1.12 Stability Study shall be performed as per “Stability Program” SOP.
4.1.13 Training of Technical Staff
4.1.13.1 Proper training needs to be given to the person involved in Technology Transfer.
4.1.13.2 The individual involved in Technology Transfer shall have qualification, knowledge and experience or any combination of it to carryout the desired job responsibility.
4.1.13.3 Training of Personnel involved in technology transfer shall be evaluated in respective study protocol.
4.1.14 Any deviation occurred during Technology Transfer shall be well documented.
4.2 Transfer of Manufacturing Process of dosage forms from [Company name]. To another production site.
4.2.1 On receiving intimation of technology transfer of dosage forms from [Company name] to another production site, QA personnel shall send the uncontrolled copy of following document to receiving site.
a. BMR / BPR / TMD
b. Specification for Raw Material / Packing Material / intermediates / Finished product
c. General Test Procedure
d. Stability Data
e. Vendor Information
4.2.2 If any requirements other than covered in above point raised by receiving site, same shall be issued as uncontrolled copy with prior approval of Head QA.
4.2.3 Execution of Technology transfer activity shall be done as pre receiving site procedure.
5.0 ANNEXURES :
Annexure I Documents received from Transferring Site / R&D / CQA / ADL
Annexure II Documents received from Transferring Site
Annexure III Evaluation of site for Manufacturing of Transferred Product
Annexure IV Evaluation and Gap Analysis
Annexure I Documents received from Transferring Site / R&D / CQA / ADL
1. Report of Development Batch
2. Master Manufacturing Document (MMD)
3. Technical Analytical Document (TAD)
4. General test procedure (GTP)
5. Specification for Raw Material
6. Specification for Packing Material
7. BOM Raw Material
8. BOM Packing Material
9. Availability of vendor Dockets
10. Storage Requirement
11. PDE Value
12. Any other documents
Verify By (QA department):
Date
Annexure II Documents received from Transferring Site
1. Executed BMR / BPR / TMD
2. Specification for Raw Material / Packing Material / intermediates / Finished product
3. General Test Procedure
4. Packaging instruction
5. Stability Data
6. Vendor Information
7. List of equipment used in manufacturing
8. Storage condition requirement
9. Summary of process parameter
10. Storage Requirement
11. PDE Value
12. Any other documents
Verify By (QA department):
Date
Annexure III Evaluation of site for Manufacturing of Transferred Product
Note: Any Modification Required in existing system for Above mentioned product
Product Name:
Product Code:
Available Existing Systems to be evaluated for any Modification
01. Procedure for Process Validation Program
02. Procedure for Procedure for Training of Plant Personnel
03. Preventive maintenance schedule for the equipment involved in manufacturing
04. Procedure for handling the breakdown of equipment
05. Calibration schedule for all the gauges, sensors, measuring devices
06. Equipment usage log book, cleaning records
07. Procedure for equipment and utility qualification and periodic verification.
08. All the product contact surface of the equipment are non-reactive, non-additive, or non-absorptive
09. Sufficient Production area for above product
10. Production area allows the effective cleaning and maintenance to avoid cross contamination
11. Proper Illumination level in the manufacturing area.
12. Floor, wall, ceiling, joints coved with an easily washable material and free from cracks and peel off.
13. Drains are of adequate size and designed to prevent back-siphonage.
14. Sanitization procedure for the area on regular basis as per the schedule.
15. Access to the critical area is limited to the authorized person only.
16. Area clearance has been available from QA prior to start of manufacturing activity.
17. Door interlock system to prevent the cross contamination.
18. Smoke detector to prevent the fire accidents.
19. Fire hydrant system with sufficient capacity of water level.
20. Maintenance Programme / procedure of fire extinguisher provided in the facility.
21. All the pipelines identified by proper color-coding.
22. Procedure for regular sanitization of the purified water loop system.
23. Material of construction used for build up of distribution line is SS316L.
24. All the electrical panels are embedded in the walls.
25. Drawings for HVAC system, Pressure Zoning.
26. Air flow diagram for each air-handling unit.
27. Duct lay out.
28. Approved drawing indicating location for dust extraction system.
29. Schedule of filter cleaning.
30. Procedure and defined criteria for replacement of primary & secondary filters.
31. Procedure for HEPA filters Integrity test.
32. Procedure for replacement of HEPA filters.
33. Procedure for monitoring of Air velocity below the HEPA filter.
34. Procedure for water system sanitization available.
35. Procedure for cleaning of water system / water storage tank.
36. All physical & chemical tests procedure performed on water available.
37. Procedure for passivation of purified water loop system.
Remark:__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Any change in above system shall be done through Change control procedure as per requirement basis, and any deviation during technology transfer shall be well documented.
QA
Production
Head QA
Annexure IV: Evaluation and Gap Analysis
Product Name :
Product code given by [Company name]Lab. Ltd :
Expiry period given by transferring site :
Evaluation and Gap Analysis Shall be done under following Headings
1. Area of manufacturing and Equipment Comparison
[This point include the comparison of manufacturing equipment including capacity, Stage wise equipment, working principle]
2. Any special requirement for addition of facility to manufacture given product E.g… lighting, Equipment
[Using Annexure III, Evaluation of site for Manufacturing of Transferred Product]
3. Temperature / Relative humidity requirement stage wise
[Using TMD / MMD / BMR / BPR / Development report received from Receiving Site or R&D]
4. Product / Raw material Specification comparison and vendor source
[Using Specification received from transferring site and Specification received from CQA]
5. Analytical Method Validation / Technology transfer Documentation
[Check that method transfer / Method validation activity successfully complete before commencement of Batch]
6. Special sampling requirement (if any)
[Using TMD / MMD / BMR / BPR / Development report received from Receiving Site or R&D]
7. Conclusion from Summary for Evaluation of cleaning validation / Verification requirement for respective product
8. Qualification status of Utility i.e. HVAC, Water and Compressed Air system
9. Deviation (if any)