GMP Clearance Guidance - Therapeutic Goods Administration

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GMP clearance guidanceVersion 18.3, July 2019

Therapeutic Goods AdministrationCopyright Commonwealth of Australia 2019This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, ifyou are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use thereproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of thatreproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all otherrights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic orotherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiriesconcerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box100, Woden ACT 2606 or emailed to tga.copyright@tga.gov.au .GMP clearance guidanceV18.3 July 2019Page 2 of 84

Therapeutic Goods AdministrationContentsGMP clearance basics 9What GMP clearance is 9Why GMP clearance is required 9What manufacturing steps require GMP clearance 9How GMP clearance is obtained 10How much GMP clearance costs 10How long GMP clearance takes 12Prioritisation requests 12What you should provide -------------- 12TGA vs Industry time 13How to interpret the status of your application ----------------------------------- 15Sponsor responsibilities 16The GMP clearance process 16Step 1 – Understanding your supply chain and establishingagreements 17A typical global supply chain 17Step 2 – Identifying the appropriate GMP clearancepathway 18Mutual Recognition Agreements (MRA) 18Compliance Verification (CV) 18TGA on-site inspection 19Step 3 – Identifying what documentation is required 20MRA pathway documentation 21CV pathway documentation 21General documentary requirements 22GMP certificates 22Why we require -------------------------- 22What you should provide -------------- 22Take particular care -------------------- 23Alternative evidence (for MRA pathway only) ------------------------------------- 23Liaison -------------------------------------- 23Most recent inspection report 24GMP clearance guidanceV18.3 July 2019Page 3 of 84

Therapeutic Goods AdministrationWhy we require -------------------------- 24What you should provide -------------- 24Take particular care -------------------- 25Regulatory inspections list 25Why we require -------------------------- 25Take particular care -------------------- 25Regulatory action details 25Why we require -------------------------- 25What you should provide -------------- 26Take particular care -------------------- 26Alternative evidence -------------------- 26Site master file, quality manual or equivalent 26Why we require -------------------------- 26What you should provide -------------- 26Take particular care -------------------- 26Alternative evidence -------------------- 26List of products intended for supply 27Why we require -------------------------- 27What you should provide -------------- 27Take particular care -------------------- 27GMP agreement or equivalent 27Why we require -------------------------- 27What you should provide -------------- 27Take particular care -------------------- 27Additional entities and alternative evidence -------------------------------------- 28Release procedure(s) 29Why we require -------------------------- 29What you should provide -------------- 29Take particular care -------------------- 30Validation master plan 30Why we require -------------------------- 30What you should provide -------------- 30Take particular care -------------------- 30Latest Product Quality Review 30Why we require -------------------------- 30What you should provide -------------- 30Take particular care -------------------- 30GMP clearance guidanceV18.3 July 2019Page 4 of 84

Therapeutic Goods AdministrationAlternative evidence -------------------- 31List of authorised tests (for contract testing labs only) 31Why we require -------------------------- 31What you should provide -------------- 31Take particular care -------------------- 31Other types of evidence 31API declaration --------------------------- 31Letters of access -------------------------- 32TGA certificates -------------------------- 33Step 4 – Creating your application 34Accessing TGA Business Services 34Creating a new application 34Completing Application Details 36Completing Client Details tab 37Sponsor ------------------------------------- 37Agent acting on behalf of a sponsor - 37Selecting the manufacturer name and manufacturing site address --------- 38Step 5 – Selecting your scope 41Completing API/Product Details tab 41API scope ----------------------------------- 42Finished Product Scope ---------------- 44Step 6 – Providing your evidence 45Choosing your evidence and delivery method 46Mandatory certificates or letters 46Delivery methods ------------------------ 47Mandatory evidence -------------------- 51Optional evidence ----------------------- 52Step 7 – Submitting your complete application and payingfees 53Fees and Payments tab 53Declaration tab 53Validating your application 53Submitting your application 54Paying your application fee 54GMP clearance guidanceV18.3 July 2019Page 5 of 84

Therapeutic Goods AdministrationStep 8 – Application receipt 55CV pathway 55Step 9 – Application assessment 57MRA pathway 57CV pathway 57Step 10 – Making a determination and assigning expirydates 59Issued 59Issued with a condition 60Not issued 60MRA pathway only ----------------------- 60Step 11 – Maintaining your active GMP clearance 62Variations to in-process GMP clearances 62Renewals, changes and extensions 62Creating a variation application 63Change clearance details - Scope, applicant or manufacturer changes64Change to manufacturer details - Administrative--------------------------------- 65Change to manufacturer details – Physical ----------------------------------------- 67Change of sponsor or applicant details ---------------------------------------------- 68Change of scope -------------------------- 69Change clearance status – Cancel or extend 70Cancel your GMP clearance ----------- 70Extending your current GMP clearance expiry date------------------------------ 70Renewals 73Transferring your GMP clearance 74Withdrawing GMP clearance applications no longerrequired 75Cancellation or reduction in scope by TGA 76Evidence naming conventions 77How to create a zip file 79Keep up to date 80GMP clearance guidanceV18.3 July 2019Page 6 of 84

Therapeutic Goods AdministrationTroubleshooting 80GMP clearance guidanceV18.3 July 2019Page 7 of 84

Therapeutic Goods AdministrationThis guidance is for sponsors seeking to obtain Good Manufacturing Practice (GMP) clearancefor an overseas manufacturing site used in the manufacture of a medicine, or an ActivePharmaceutical Ingredient (API) used in a medicine, intended for supply in Australia.This guidance is not intended for sponsors of: biologicals, human blood and blood components and HaematopoieticProgenitor Cells (HPCs), because Australia has its own manufacturingstandard for these product types; however, where the manufacturing siteperforms only sterilisation of these product types, this guidance may beusedsome complementary and listed medicines, including sunscreens,because these may not be regulated as medicines in other countriesFurther information is available in the Australian manufacturing licences andoverseas GMP certification guidance.GMP clearance guidanceV18.3 July 2019Page 8 of 84

Therapeutic Goods AdministrationGMP clearance basicsWhat GMP clearance isGMP Clearance is a non-statutory mechanism used to verify that overseas manufacturing sitescomply with the principles of GMP for the products being supplied to Australia. It wasintroduced as a way to reduce the regulatory burden on industry while maintaining assurancethat the suitability of manufacturing processes and quality control procedures are appropriate.The TGA may issue GMP clearance to sponsors of a medicine or API that is manufacturedoverseas if there is acceptable evidence demonstrating that the overseas manufacturer complieswith the principles of GMP (the manufacturing principles or equivalent standards).Why GMP clearance is requiredSponsors are required to obtain GMP clearance for overseas manufacturers of their registered orlisted products to sa

Therapeutic Goods Administration GMP clearance guidance V18.3 July 2019 Page 9 of 84 GMP clearance basics What GMP clearance is GMP Clearance is a non-statutory mechanism used to verify that overseas manufacturing sites

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