GMP for ATMP. Advanced Therapy Medicinal Products Key2Compliance AB

Transcription

1 GMP for ATMP Advanced Therapy Medicinal Products 2018 Key2Compliance AB 1

2 Content Background and regualtory requirements GMP Walkthrough Quality Risk Management 2018 Key2Compliance AB 2

3 Background and regulatory requirements 2018 Key2Compliance AB 3

4 When??? 2018 Key2Compliance AB 4

5 Medicinal products Classification of ATMP s ument_library/regulatory_and_procedural_g uideline/2012/04/wc pdf If Medicinal product GMPs apply And more 2018 Key2Compliance AB 5

6 GMP applies! Permit from LV also needed! Hospital exemption ATMP with MA ATMP used in Clinical trial 2018 Key2Compliance AB 6

7 2018 Key2Compliance AB 7

8 2018 Key2Compliance AB 8

9 GMP applies GMP Part IV (from May 22, 2018) Annex 1 (Sterile medicinal products) Draft update published Annex 11 (Computerised systems) Annex 12 (Ionisation radiation) 2018 Key2Compliance AB 9

10 GMP Walkthrough EU GMP Guide, Part IV 2018 Key2Compliance AB 10

11 1. Introduction 2. Risk-based approach 3. Personnel 4. Premises 5. Equipment 6. Documentation 7. Starting and raw materials 8. Seed lot and cell bank system 9. Production 10. Qualification and validation 11. QP and batch release 12. Quality Control 13. Outsourced activities 14. Quality defects and product recalls 15. Environmental control (GMOs) 16. Reconstitution Automated production of ATMPs 2018 Key2Compliance AB 11

12 1. Introduction Scope Both commercial and for Clinical trials MA/CTA must always be followed General principles Quality System and GMP Ensure QS is effective PQR for authorised ATMPs 2018 Key2Compliance AB 12

13 2. Risk-based approach Wait for it Key2Compliance AB 13

14 Risk management and ATMPs ATMPs Complex Different risks Inherent variability Innovation Rapid changes Academic/hospital setting Different QS Flexibility Early clinical phases Evolving knowledge 2018 Key2Compliance AB 14

15 Quality Equal application of RBA = Risk-Based Approach GMP compliance Hospital Academic Industry Safety Efficacy 2018 Key2Compliance AB 15

16 Necessary controls/mitigations Flexibility Level of effort and documentation commensurate with the level of risk! Authorised ATMP Protection of subjects Reliable test results Consistent with CTA Investigational ATMP Strategy agreed in MA 2018 Key2Compliance AB 16

17 Examples of RBA Raw materials Testing strategy No substantial manipulation Investigational ATMPs 2018 Key2Compliance AB 17

18 4. Premises Errors Contamination and cross-contamination Adverse effect on quality 2018 Key2Compliance AB 18

19 5. Equipment 2018 Key2Compliance AB 19

20 7. Starting and raw materials Raw materials Consider Ph. Eur Ideal Pharma grade May rely on Certificate if risks understood Biological origin TSE! Starting materials Tissues, cells Directive 2004/23/EC or 2002/98/EC Quality agreements May need to audit Properly identified, labelled and stored Released by QC before use If test takes long time, may be OK to use if risks understood and mitigated 2018 Key2Compliance AB 20

21 9. Production Phase III Authorised product Phase I/II Procedures and instructions more and more detailed as knowledge increases 2018 Key2Compliance AB 21

22 9. Production 2018 Key2Compliance AB 22

23 10. Qualification and validation Transport conditions Process Test methods Clean room Cleaning 2018 Key2Compliance AB 23

24 11. QP and Batch release Products with short shelf life Unplanned deviations and OOS The release process 14 items QP Competence 2018 Key2Compliance AB 24

25 12. Quality Control Approval of specifications, instructions, procedures Approvals of outsourced testing Control of materials Supervision of reference/retention samples Ensure testing and evaluation of records Stability monitoring Participation in investigations 2018 Key2Compliance AB 25

26 13. Outsourced activities Contract giver Contract acceptor 2018 Key2Compliance AB 26

27 14. Quality defects and product recalls Correction CAPA system Preventive action Corrective action 2018 Key2Compliance AB 27

28 17. Automated production of ATMPs Equipment suitable for intended purpose CE mark may or may not be relevant Qualification required Sufficient data from equipment manufacturer SOPs, maintenance etc Key2Compliance AB 28

29 2018 Key2Compliance AB 29

30 Thank you for your attention! 2018 Key2Compliance AB 30