SOP for Technology Transfer of ANDA product from one site to other site
1.0 OBJECTIVE:
The objective of this standard operating procedure is to provide instruction and describe the system for the requirements and actions necessary to effectively plan and execute a successful transfer of technology for ANDA product from one manufacturing site to manufacturing site of [company name].
2.0 SCOPE:
This Standard Operating Procedure (SOP) covers the procedure for transfer of technology for ANDA product from one manufacturing site to manufacturing site of [company].
3.0 RESPONSIBILITY:
3.1 Previous ANDA manufacturing site: To transfer all the relevant documents pertaining to ANDA product to regulatory department of [company name].
3.2 Regulatory department of this site:
• To receive all the relevant documents pertaining to ANDA product from previous site.
• To send the received documents to location QA.
3.3 Location QA of this site:
• Receive the documents from Regulatory department.
• Compare the information about equipment, process, testing and evaluate the same so to determine the level of compliance support that is required.
• Ensuring that the product to be produced at this manufacturing site is of comparable quality to product produced at the previous site and all filing and regulatory requirements are met.
4.0 PROCEDURE:
4.1 Overview:
4.1.1 This SOP is designed to ensure that the cGMP compliance standard are met and product quality remains consistent when ANDA product transferred from one site to manufacturing site of [company].
4.2 Evaluation of this site for manufacturing of ANDA product:
4.2.1 Identify the reference dosage form which must be used for comparison.
4.2.2 The equipment that are currently in place shall be evaluated to ensure that the formulation process will be comparable.
4.2.3 The design of the facility should be evaluated for personnel flow, product and material flow, cleanliness zones, safety classes and support systems. The support system should discuss pipelines, electrical system, HVAC system, water systems and any other applicable utility.
4.2.4 The evaluation must consider Principle, capacity, material of construction data, computer control parameters and special enhancements of the equipment.
4.2.5 To ensure that the equipment qualification are performed under any new parameters that the process might include prior to process validation.
4.2.6 All the transferred product shall be evaluated regarding the necessity for cleaning validation.
4.2.7 The suppliers shall not be changed if assumed to have any negative impact on process quality.
4.2.8 Once all information regarding product is gathered from the previous site and is transferred to this site an evaluation of capability (Gap Assessment) to be performed.
4.2.9 Evaluation of new site for manufacturing ANDA product shall be documented as per annexure – I.
4.3 Documentation Requirements: The minimum documents required for technology transfer of ANDA product from any site to this site are as under: (All the documents shall be received as photocopy of the original exhibit documents)
4.3.1 Batch Manufacturing Record and Batch Packaging Records along with equipment size, material of construction data, and in process controls data for critical and non-critical parameters.
4.3.2 Process validation summary shall be received. If all equipment is like for like then the validation process can be limited. If the equipment does vary then extra validation work will be necessary.
4.3.3 Storage requirement for raw materials, in-process materials, intermediates and finished product including any retest or expiration dates.
4.3.4 Specification and testing procedure for raw materials, in process materials, intermediates and finished product.
4.3.5 Summary of the Stability data should be received.
4.3.6 Documentation requirement shall be identified as per the annexure – II
4.4 Execution of job after Technology Transfer:
4.4.1 All transferred product must undergo full or partial validation based on Gap Analysis. An approved validation protocol must be available prior to conducting the study.
4.4.2 Three consecutive batches shall be subjected to process validation on the equipment which are that has been suitably qualified and calibrated (If Applicable).
4.4.3 Validation shall be performed with the approved batch records and methods should be qualified prior to testing.
4.4.4 For product with multiple strength with similar formulation and manufacturing processes, a matrix may be considered using a high strength / low strength bracketing approach however all strength needs to be evaluated at least once.
4.4.5 If the process remains the same, equipment is similar, and batch size is not altered then ranges for in-process and critical parameters do not need to be challenged.
4.4.6 If equipment, process or formulation is different then development work and more comprehensive testing and sampling should occur to challenge in-process or critical parameter ranges.
4.4.7 Validation sampling and testing plans should be followed as per protocol.
4.4.8 No re-validation of the transferred control procedure and testing monographs will be required. However the method must be initially verified by the site and method must not be outside the original validation parameters.
4.4.9 Method transfer should be performed to verify that this site laboratory has the ability to perform the required testing. A protocol should be written to address the acceptance criteria for location laboratory.
4.4.10 When requested by regulatory authorities, or wherever significant changes in the process material have occurred, or for any products with identified or expected stability problems, a comparative accelerated stability study is performed with at least one of the three first batches manufactured at this site. The accelerated stability results of the first batch for three month must be available for product release.
4.4.11 Where regulatory authorities request it, or where any product specific characteristic is depending upon a given dissolution profile, such profile will have to be recorded by comparing at least one of the three first batches manufactured at this site to a reference batch defined by previous site.
4.4.12 This manufacturing site has to procure sufficient reference standard materials.
4.4.13 Changes in the site and/or process of manufacturing and primary packaging, as well as suppliers and/or quality of raw and primary packaging materials, must be appropriately updated in the documentation in order to comply with the requirements of the regulatory authorities prior to the distribution of the product.
4.5 Training / confirmation of technical staff of site:
4.5.1 Proper training needs to be imparted to the person involved in Technology Transfer.
4.5.2 The individual involved in Technology Transfer shall have qualification, Knowledge and Experience or any combination of it to carryout the desired job responsibility.
4.6 Deviation Handling Process:
4.6.1 Any deviation observed during Technology Transfer of ANDA product from one Manufacturing site to this manufacturing site, related to Man, Material, Machine and Process shall be handled through Incident Deviation programme
5.0 ANNEXURES :
Annexure – I: Check list for Evaluation of site for manufacturing of ANDA product
Annexure – II: Checklist for Documents received from previous ANDA product manufacturing site to [company name].
Annexure – I: Evaluation of Site For Manufacturing ANDA Product
Sr. No. Check Points
01. The transferred dosage form can be manufactured at this site.
02. The desired batch size for the transferred product can be manufactured at this site.
03. Procedure for process validation protocol preparation available.
04. Do the employees involved are qualified, experienced and have knowledge.
05. Preventive maintenance schedule available for the equipment involved in manufacturing.
06. Procedure for handling the breakdown of equipment available.
07. Are all the gauges, sensors, measuring devices, are calibrated.
08. Equipment usage log book, cleaning records are maintained.
09. Procedure for equipment qualification available.
10. All the product contact surface of the equipment are of SS316 class.
11. Are all the equipment have the equivalent capacity to deliver the product of comparable quality.
12. Production area is sufficient to carryout the required activity.
13. Does the design of the production area allow the effective cleaning and maintenance to avoid cross contamination and adverse effect on the quality of the product.
14. Illumination level in the manufacturing area is appropriate to the activities performed.
15. Floor, wall, ceiling, joints coved with an easily washable material and free from cracks and peel off.
16. Is Drain of adequate size and designed to prevent back-siphonage.
17. Is Sanitization done for the area on regular basis as per the schedule.
18. Access to the critical area is limited to the authorized person only.
19. Area clearance has been available from QA prior to start of manufacturing activity.
20. Door interlock system available to prevent the cross contamination.
21. Smoke detector available to prevent the fire accidents.
22. Fire hydrant system available with sufficient capacity of water level.
23. Maintenance programme / procedure of fire extinguisher provided in the facility.
24. Are all the pipelines identified by proper color-coding.
25. Does the procedure for sanitization of the purified water loop system available.
26. Material of construction used for build up of distribution line is SS316L.
27. All the electrical panels are embedded in the walls.
28. Drawings for HVAC system, Pressure Zoning available.
29. List of Air Handling Units (AHU) with unique identification number and room description available.
30. Air flow diagram for each air-handling unit available.
31. Availability of duct lay out.
32. Approved drawing indicating location for dust extraction system available.
33. Availability of schedule of filter cleaning SOP.
34. Procedure and defined criteria for replacement of primary & secondary filters.
35. Integrity test procedure for HEPA filters available.
36. Procedure for replacement of HEPA filters.
37. Procedure for monitoring of Air velocity below the HEPA filter.
38. Procedure for water system sanitization available.
39. Procedure for cleaning of water system / water storage tank available.
40. All physical & chemical tests procedure performed on water available.
41. Procedure for passivation of purified water loop system available.
42. Approved vendor list available.
43. Assessment made in regards to changes to an Approved ANDA.
44. Equipment are available and no changes are required.
45. No special adjustment is needed for packaging or Raw material.
46. Protocols for process and cleaning can be used for this site.
47. Site change defined per SUPAC-IR
Annexure – II: Documents Received From Previous ANDA Product Manufacturing Site to [company name]
Sr. No. Documents Details
01. Executed Batch Manufacturing Documents (BMR).
02. Executed Batch Packaging Records (BPR).
03. List Of Equipment along with the Size / capacity details.
04. List Of In process Control Checks Performed At various stages of Manufacturing.
05. Summary of process Parameters.
06. Summary Process validation Data.
07. List Of Storage Condition For Raw Material.
08. Summary of Stability data received and available.
09. Test Specification for Raw Materials with Testing Procedure.
10. Test Specification for Intermediates with Testing Procedure.
11. Test Specification for Finished Product with Testing Procedure.
12. TSE/ BSE certificate available for raw material.
13. Use of any Novel Excipients (if any).
14. Drug product development report available.
15. Vendor docket available.
16. Analytical Method Validation available.
17. Batch Analysis report (COA) available.
18. Stability protocol prepared and available.