SOP on Transfer of Technology for Manufacturing process
- Objective:
- To lay down the procedure for Transfer of Technology for Manufacturing Process.
- Scope:
- This procedure is applicable for Transfer of technology (i.e. for Manufacturing process) from sending unit (F R&D) to receiving site (Manufacturing facility )
- Responsibility:
- Responsibility of Sending Unit (F R&D ) are :
- Create the Technology transfer Protocol.
- Execution of training for carrying out the technology transfer successfully.
- Assistance in Optimization, validation and Analysis of the batches produced during the Technology transfer.
- To define the acceptance criteria and the limits for different parameters.
- Responsibility of Receiving unit (Manufacturing Unit ) are :
- Availability of Equipments and Instruments required for Technology transfer.
- Execution of Protocol for Technology transfer.
- Availability of BMRs, BPRs and other related documents required for Manufacturing of batches in Technology transfer
- Management of Deviations and change controls.
- Accountability:
- Head of Quality assurance, FR&D, Manufacturing head and Regulatory affairs department is accountable for compliance of the system.
- Procedure:
- Reasons for Technology transfer can be following :
- New product development at F R&D to be commercialized.
- Reasons for Technology transfer can be following :
- Responsibility of Sending Unit (F R&D ) are :
- New/Revised process to circumvent patent infringement.
- New/Revised process for economic/Cost effective reasons.
- Need for additional Capacity.
- Relocation of Manufacturing site for economic advantages or any other reason.
- Process of transferring the technology (Chemistry, Manufacturing, Control and documents related to the Drug Product) from one location to another location to manufacture the consistent quality is termed as technology transfer.
- Sending Unit: F R&D that is actually transferring the technology from its site to Formulation unit.
- Receiving Unit: Manufacturing unit that is receiving the technology is Formulation unit.
- Proposal for the initiation of technology transfer shall be carried out by Head of F R & D department or his designee.
- Technology transfer team shall coordinate for the collection of all relevant documents.
- Technology Transfer team shall coordinate for the receipt of comments from all relevant department involved in technology transfer (if required) and send this to Receiving unit for Final Approval.
- Upon receipt of comments from all relevant departments, In-charge of QA department shall review the comments of each department and based on this he shall approve or reject the proposal.
- On receipt of the information about the new product at receiving unit, Quality Assurance department shall fulfill the Statutory requirement like test License, Manufacturing License, pollution control etc and ensure that a statutory requirements shall be fulfilled prior to commencement of any Manufacturing.
- On receipt of approval from Head of QA & RA department, Technology Transfer Team shall coordinate with F R&D for the collection of documents required for the Technology transfer.
- Technology Transfer team shall hand over the documents to Quality Assurance department at Receiving site.
- On receipt of all relevant documents and relevant information, QA of the receiving unit shall review and execute the technology transfer.
- On approval of proposal for technology transfer and relevant documents, QA of receiver site shall review documents along with other relevant Departments of receiver site in coordination with Technology Transfer team.
- QA of receiver site shall inform to Sending unit for any other requirement during receipt of the Technology at receiver site.
- The technology transfer documents and other details received from sending site shall be reviewed by concerned departments in consultation with QA and the technology transfer team and shall procure the equipments, instruments, change parts etc.
- QA shall give Final Clearance for the Transfer of Technology only after ensuring the cGMP compliance and other requirements.
- Based on the documents received receiving unit shall prepare the Master BMRs and Master BPRs. Preparation of Master BMR/BPR shall be done as per the SOP .
- Sending unit shall provide all the information regarding the vendors for Raw material and packing materials which shall be used in the manufacturing process. All the vendors shall be approved by QA as per the SOP for approval of Packing material vendors and SOP for approval of Raw material vendors.
- QA from the receiving site shall provide the item codes for all the Raw material and the packing material as per the SOP for Raw material codes and SOP for packing materials codes.
- Sending Unit and receiving unit will jointly plan for manufacturing of Optimization batch to check feasibility and optimizing the process parameters.
- Based on the Optimization study results , if required F R&D will revise the following documents :
- Master Formula for Manufacturing, which includes formula and manufacturing instructions including critical parameters
- Master formula for packing which includes packaging instructions including critical parameters.
- In-process controls and its specifications
- Specification of RM, PM, intermediates and finished products.
- Product Development report which includes results of optimization batches
These documents after revision shall be submitted to Receiving site QA.
- After successful completion of optimization study, if required Master BMR/BPRs shall be revised by receiving site.
- Sending unit and receiving site shall jointly plan for manufacturing of Exhibit batches in co-ordination with F R&D, Technology transfer team, Quality assurance, Production and Engineering department and shall assure the feasibility, reproducibility, quality and validation of the batches.
- Exhibit Batch Monitoring and sampling shall be done through Test Batch Monitoring Protocol which shall be prepared as product specific document.
- Time Limitation studies shall be carried out through product specific Hold time study protocol.
- Based on the results of Exhibit batch and the commercial requirements, intended BMR/BPRs shall be revised or prepared by the Receiving site QA Department.
- QA of receiver site shall prepare the documents (if any) for the execution of the drug product being transferred to Manufacturing site.
- QA of receiver’s site shall ensure that the manufacturing of the drug product at his site shall be carried out as per approved procedures.
- Once the Process Validation on three batches of commercial batch size is successfully completed, the Final report for Technology transfer shall be prepared by the Technology transfer team from Sending site and shall be signed off by the respective Heads from Sending unit and the receiving site.
- Summary reports for the transfer of technology of drug product shall be prepared by Technology Team and reviewed by QA and Manufacturing Department of receiver site and approved by Head of QA department.
- Success criteria for Technology transfer: Technology transfer shall be considered successful if a receiving unit can routinely reproduce the transferred process or product against a prescribed set of specifications. The main factors for successful Technology transfer from a Regulatory perspective are :
- Adequate technology transfer documents covering all aspects of Manufacturing process
- Establishment of Comprehensive Technical development report.
- Establishment of clearly defined specifications for the process, finished product and the other components.
- Availability of adequate and suitable facilities, equipments and trained staff at the receiving unit to accept a transferred technology.
- Establishment of Protocol/Report documenting the Technology transfers.
- Sharing the Learning and the Knowledge captured during Product /Process development stages.
- List of Annexure / Formats:
- PROPOSAL FOR INITIATION OF TECHNOLOGY TRANSFER – Annexure -1
- CHECK LIST FOR TECHNOLOGY TRANSFER – Annexure -2
- FINAL CLEARANCE BY RECEIVING UNIT QA – Annexure -3
- SUMMARY REPORT OF TECHNOLOGY TRANSFER OF PRODUCT
CONCLUSION AND CERTIFICATION – Annexure -4
- References (if any).
- SOP on SOP.
- Reason for Revision:
- New SOP initiated
Abbreviation:
-
- SOP : Standard Operating Procedure
- QC : Quality Control
- SP : Specific
- F R & D : Formulation Research and Development
- QA : Quality Assurance
- cGMP : current Good Manufacturing Practice.
- RA : Regulatory Affairs
- BMRs : Batch Manufacturing records
- BPRs : Batch Packing records
- SOP : Standard Operating procedures
- RM : Raw Material
- PM : Packing Material
Annexure -1
PROPOSAL FOR INITIATION OF TECHNOLOGY TRANSFER
| Product Details | ||
| Generic Name: | Dosage Form: | |
| Dedicated Facility required: | Markets to be supplied: | |
| Temperature required in Mfg area: | Relative Humidity in Mfg. area : | |
| Temperature required in Pkg. area: | Relative Humidity in Pkg. area : | |
| Type of Technology Transfer : Manufacturing process | ||
| Stage: Pilot bio batch/Optimization study/ Scale Up study/ Exhibit batch/ Intended commercial/ Validation [tick (√) on the applicable stage and strike (—) remain.]
If any other Specify:- |
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| Specific requirement of Manufacturing facility (if any) | ||
| Manufacturing Method: | ||
| Manufacturing Change Parts: | ||
| Manufacturing Equipment: | ||
| Packing Change-parts including PS: | ||
| Packing Equipment: | ||
| Type of Pack: | ||
| Packing Change Parts will be sent to the proposed location (includes PS): | ||
| Comments:
|
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Forwarded by………………………….on…………………………..
| Regulatory Affairs Confirmation |
| Comments:
Sign/Date : |
| F R&D Confirmation |
| Poduct related Specific instructions if any: |
| Comments: –
Sign/Date : |
| Receiving site Quality Assurance Confirmation : |
| Facility Evaluation:
|
| Comments:
Sign/Date :
|
| Receiving Site Quality Control Confirmation : | ||
| Working Standard I Instruments I Columns Availability Analytical Method Validation & action plan |
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| Comments:
Sign/Date : |
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| Product Receiving Unit Plant Manager Confirmation : | ||
| Manufacturing Equipment availability details & action Plan: | ||
| Packing Equipment availability details & action plan: | ||
| Manufacturing Change Parts availability details & action plan: | ||
| Packing Change Parts availability details (inc PS) & action plan: | ||
| Environmental Conditions suitability as mentioned by Initiator & FR&D: | ||
| Comments: | ||
| NAME | ||
| SIGNATURE | ||
| DATE | ||
Annexure -2
CHECK LIST FOR TECHNOLOGY TRANSFER
Sending Unit:
Receiving Unit:
Date:
Product:
Stage:
| Sr. No. | Documents | Documents Received from Sending Unit & Re-formatted for Receiver’s site if required |
Justification if content of reformatted receiver’s documents differ from donor’s documents by QA |
||
| Yes | No | Not applicable | |||
| 1 | MFC | ||||
| 2 | MPR | ||||
| 3 | Formulation Rationale | ||||
| 4 | Product Development report | ||||
| 5 | Technology Transfer Protocol | ||||
| 6 | In—process control checks | ||||
| 7 | Analytical method validation of Active Pharmaceutical Ingredient, In-process and Finished drug product. | ||||
| 8 | Stability study specifications and standard test procedure. | ||||
| 9 | Stability data of Pilot Bio-Batch | ||||
| 10 | Conclusion from stability studies, shelf life & storage conditions. | ||||
| 11 | Bioavailability & Bioequivalence report wherever applicable. | ||||
| 12 | Clinical information (If any).
History of Clinical Batches |
||||
| 13 | Identify all Pivotal batches(Clinical /Bio-equivalency /Stability) | ||||
| 14 | Drug product information
(if any). |
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| 15 | Package insert | ||||
| 16 | Drug product sample for comparison studies along with certificate of analysis. | ||||
| 17 | Details of change parts. | ||||
| 18 | Cleaning methods at various manufacturing process steps. | ||||
| 19 | Analytical method validation for cleaning samples. |
Prepared By: Checked By:
Sign/Date: Sign/Date:
Annexure -3
FINAL CLEARANCE BY RECEIVING UNIT QA
| Sr.No. | Activity | Responsibility | Quality assurance Activity (Completion Status) |
| 1 | cGMP compliance status of identified manufacturing facility. | ||
| 2 | Commercial batch size fixation | ||
| 3 | Sample tablets, dimension data. | ||
| 4 | Approved art work to Purchase management for packaging material procurement. | ||
| 5 | Manufacturing License . | ||
| 6 | Raw material & Packaging material procurement. | ||
| 7 | Punch Tooling and packaging change parts procurement. | ||
| 8 | Any other information. | ||
| Final Clearance by QA | |||
| Name: | |||
| Designation : | |||
| Signature:
(Date) |
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Annexure -4
SUMMARY REPORT OF TECHNOLOGY TRANSFER OF PRODUCT
CONCLUSION AND CERTIFICATION
This is here by concluded that the Technology Transfer has been successfully completed at site
Formulation unit for the product……………………………………….
and receiver accept the product for future manufacturing.
| Prepared by
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Reviewed by
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Approved by
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| Departments | Technology Transfer Team
(Sending Unit) |
Production
(Receiving site) |
QA
(Receiving site) |
Head
QA
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| Name |
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| Designation |
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| Signature |
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| Date |
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