Transcription of GMP clearance guidance
1 GMP clearance guidance Version , July 2019. Therapeutic Goods Administration Copyright Commonwealth of Australia 2019. This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so.
2 Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to GMP clearance guidance Page 2 of 84. July 2019. Therapeutic Goods Administration Contents GMP clearance basics _____ 9. What GMP clearance is _____ 9. Why GMP clearance is required _____ 9. What manufacturing steps require GMP clearance _____ 9. How GMP clearance is obtained _____ 10. How much GMP clearance costs _____ 10. How long GMP clearance takes _____ 12.
3 Prioritisation requests _____ 12. What you should provide ---------------------------------------- ------------------------ 12. TGA vs Industry time _____ 13. How to interpret the status of your application ----------------------------------- 15. Sponsor responsibilities _____ 16. The GMP clearance process _____ 16. Step 1 Understanding your supply chain and establishing agreements _____ 17. A typical global supply chain _____ 17. Step 2 Identifying the appropriate GMP clearance pathway _____ 18. Mutual Recognition Agreements (MRA) _____ 18.
4 Compliance Verification (CV) _____ 18. TGA on-site inspection _____ 19. Step 3 Identifying what documentation is required 20. MRA pathway documentation_____ 21. CV pathway documentation _____ 21. General documentary requirements _____ 22. GMP certificates _____ 22. Why we require it-------------------------------------- ------------------------------------ 22. What you should provide ---------------------------------------- ------------------------ 22. Take particular care ---------------------------------------- ------------------------------ 23.
5 Alternative evidence (for MRA pathway only) ------------------------------------- 23. Liaison ---------------------------------------- ---------------------------------------- -------- 23. Most recent inspection report _____ 24. GMP clearance guidance Page 3 of 84. July 2019. Therapeutic Goods Administration Why we require it-------------------------------------- ------------------------------------ 24. What you should provide ---------------------------------------- ------------------------ 24. Take particular care ---------------------------------------- ------------------------------ 25.
6 Regulatory inspections list _____ 25. Why we require it-------------------------------------- ------------------------------------ 25. Take particular care ---------------------------------------- ------------------------------ 25. Regulatory action details _____ 25. Why we require it-------------------------------------- ------------------------------------ 25. What you should provide ---------------------------------------- ------------------------ 26. Take particular care ---------------------------------------- ------------------------------ 26.
7 Alternative evidence ---------------------------------------- ------------------------------ 26. Site master file, quality manual or equivalent _____ 26. Why we require it-------------------------------------- ------------------------------------ 26. What you should provide ---------------------------------------- ------------------------ 26. Take particular care ---------------------------------------- ------------------------------ 26. Alternative evidence ---------------------------------------- ------------------------------ 26.
8 List of products intended for supply _____ 27. Why we require it-------------------------------------- ------------------------------------ 27. What you should provide ---------------------------------------- ------------------------ 27. Take particular care ---------------------------------------- ------------------------------ 27. GMP agreement or equivalent _____ 27. Why we require it-------------------------------------- ------------------------------------ 27. What you should provide ---------------------------------------- ------------------------ 27.
9 Take particular care ---------------------------------------- ------------------------------ 27. Additional entities and alternative evidence -------------------------------------- 28. Release procedure(s) _____ 29. Why we require it-------------------------------------- ------------------------------------ 29. What you should provide ---------------------------------------- ------------------------ 29. Take particular care ---------------------------------------- ------------------------------ 30. Validation master plan _____ 30.
10 Why we require it-------------------------------------- ------------------------------------ 30. What you should provide ---------------------------------------- ------------------------ 30. Take particular care ---------------------------------------- ------------------------------ 30. Latest Product Quality Review _____ 30. Why we require it-------------------------------------- ------------------------------------ 30. What you should provide ---------------------------------------- ------------------------ 30.
