Andrew Hopkins
Scope GMP for ATMPs Points to consider Survey MHRA next steps Questions 2
GMP for ATMPs The usual process for GMP updates Problem statement submitted to IWG and PIC/S Reviewed and if accepted drafting Working Group set up with clear objective and mandate Draft prepared and submitted to PIC/S and IWG for consideration Issued for public consultation Comments reviewed and decisions recorded and justified Update document published with 6 month implementation 3
The process for GMP for ATMPs First draft seen in September 2016 Draft prepared by CAT and Commission Prepared as a response to a perceived problem Initially input from inspectors was limited Public consultation occurred Inspectors asked to participate in 2 weekly TCs Rewrite resulted in bigger document Public consultation Published in December to 2017 with implementation May 2018 4
Scope GMP for ATMPs Points to consider Survey MHRA next steps Questions 5
Points to consider Process did not involve agencies outside of EU Document disconnects from part 1 of EU GMP Current part 1 built on (bad) experiences Not clear what the maintenance system is Wholesale cut and paste of much of the GMPs in part 1 6
Points to consider (the details) The new guidance does cover some areas that are specific to ATMPS and in this respect is beneficial 7
Points to consider(the details) 1.11 article 5 mandates a separate GMP 1.12 Not sure that NCAs can be told not to add to regs requirements Appears to give more flexibility, but in doing so also gives less clarity Difficult for manufacturers Difficult for inspectors May need more interpretive documents to support the new GMP 8
Points to consider (the details) Some general issues that may cause interpretational difficulties: Structure may not be logical, for instance guidance on sterile facilities appears in a number of sections Section 17 on automated processes 9
Points to consider (the details) Some general issues that may cause interpretational problems: Some statements give flexibility but do not give clarity e.g: 2.1.1 seems to give hospitals and academia room to not have an effective PQS 2.2 Specifies a Risk based approach, but not really giving guidance on what this looks like 2.25 Allows flexibility if agreed in the MA, including facilities and equipment Question: If agreed in an MA can a deficiency be cited in an inspection? 2.50 Allow flexibility of manufacture of early stage trials in A with C background in exceptional circumstances Question: What do you think exceptional circumstances are? 10
Points to consider (the details) Some general issues that may cause interpretational problems: Some elements currently covered by part 1 not captured: Notable example is Annex 11 So without the link to part 1 what are the expectations 11
Scope GMP for ATMPs Points to consider Survey MHRA next steps Questions 12
Survey Why do it Are there problems? If so what are they Without clearly defining any problems we cannot offer an effective fix What are you looking for: Evidence of GMPS being prohibitive to innovation Any items considered to be over the top in existing GMPS Any thing lacking in existing GMPS Elements that help in the new GMPS Anything that is not so good in new GMPS 13
Scope GMP for ATMPs Points to consider Survey MHRA next steps Questions 14
MHRA next steps Complete/close out survey Compile Reponses Assess responses Publish results and our proposed responses Publish our intended approach to inspection going forward Work with PIC/S 15
MHRA next steps (story so far) Received some responses back (just into double figures?) Need more Nature of feedback: Generally agreeing that the new GMP needs further consideration for inspection etc. Some quite specific topics e.g. more guidance on release of OOS materials Some verbal feedback regarding smaller manufacturers welcome flexibility Need more feedback, it is an important issues and we (MHRA and industry) need and want to get it right. 16
Thank you for listening Any questions? 17
Contact Andrew Hopkins Expert GMDP Inspector andrew.hopkins@mhra.gov.uk www.mhra.gov.uk https://www.gov.uk/government/groups/mhra-innovation-office Complete our Innovation Office enquiry form or send an email to innovationoffice@mhra.gov.uk. 18
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