12 September 2016 EMA/INS/GMP/733843/2015 Committees and Inspections

Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2015

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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

Table of contents Table of contents ......................................................................................... 2 1. Introduction ............................................................................................ 3 2. Meetings .................................................................................................. 3 3. GMP inspections in third countries .......................................................... 3 4. Mutual recognition agreements (MRAs) and other agreements on GMP .. 5 4.1. MRA General ........................................................................................................ 5 4.2. MRA with Japan.................................................................................................... 5 4.3. MRA with Canada ................................................................................................. 5 4.4. MRA with Switzerland ........................................................................................... 5 4.5. MRA with Australia ............................................................................................... 5 4.6. MRA with New Zealand.......................................................................................... 5 4.7. ACAA with Israel .................................................................................................. 5 4.8. Other international collaborations on GMP ............................................................... 5

5. Harmonisation topics............................................................................... 6 5.1. Joint Audit Programme (JAP) ................................................................................. 6 5.2. Compilation of Union Procedures on Inspections and Exchange of Information ............. 6

6. GMP and GDP guidance............................................................................ 6 6.1. GMP Guide: Chapter 3 (Premises and Equipment) and Chapter 5 (Production) ............. 6 6.2. GMP Guide: Chapter 8 (Complaints, Quality Defects and Product Recalls) .................... 6 6.3. GMP Guide: Annex 1 (Manufacture of Sterile Medicinal Products) ............................... 7 6.4. GMP Guide: Annex 13 (Manufacture of Investigational Medicinal Products) .................. 7 6.5. GMP Guide: Annex 15 (Qualification and Validation) ................................................. 7 6.6. GMP Guide: Annex 16 (Certification by a Qualified Person and Batch Release) ............. 7 6.7. GMP Guide: Annex 17 (Real Time Release Testing) ................................................... 7 6.8. GMP for importers of medicinal products (“Annex 21”) .............................................. 7 6.9. EudraGMDP database ............................................................................................ 7 6.10. Q&A .................................................................................................................. 7

7. Collaboration with the European Commission.......................................... 8 8. Liaison with other groups ........................................................................ 8 8.1. International Conference on Harmonisation (ICH) ..................................................... 8

Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2015 EMA/INS/GMP/146965/2015

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1. Introduction This document is the annual report of the GMP/GDP Inspectors Working Group (GMDP IWG) for the year 2015. This group was established at EMA in 1996. The GMDP IWG provides input and recommendations on all matters relating directly or indirectly to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). The GMDP IWG focuses on harmonisation and co-ordination of GMP and GDP related activities at EU level. The group's role and activities are described in more detail in its mandate, which was revised in 2013. This annual report is set out in line with the format and objectives of the 2015 work plan.

2. Meetings The plenary GMP/GDP IWG meetings took place on: •

03-05 March 2015



16-18 June 2015



28-30 September 2015 (Joint with QWP on 30 September)



24-26 November 2015 (Interested Parties meeting on 26 November)

In addition, drafting group meetings have been held by teleconference or other virtual meeting technology. The Compliance Group, managing the Joint Audit Programme (JAP), also met on four occasions in 2015.

3. GMP inspections in third countries The number of sites inspected in 2015 by EEA authorities in third countries was 449. Out of these, 436 sites received GMP certificates whereas 13 sites received non-compliance statements.

Outcome of EEA Inspections in Third Countries in 2015 500 450 400

436

350 300 250

GMP Certificates

200

GMP Non-Compliance Statements

150 100 50

13

0 GMP Certificates

GMP Non-Compliance Statements

Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2015 EMA/INS/GMP/146965/2015

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Inspection outcome

Year 2015

GMP Certificates

436

GMP Non-Compliance Statements

13

A breakdown of the figures corresponding to those third countries where EEA authorities conducted the highest number of GMP inspections in 2015 is given below. They have been split according to their outcome (i.e. GMP certificates vs. non-compliance statements). 2015 Country

GMP certificates

GMP Non-compliance statements

India

135

6

United States

110

1

China

72

6

Turkey

18

0

Japan

13

0

9

0

79

0

Taiwan ROW*

*ROW includes the following countries: Argentina, Bahamas, Bangladesh, Belarus, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, Ecuador, Egypt, Indonesia, Israel, Jordan, Republic of Korea, the former Yugoslav Republic of Macedonia, Malaysia, Mexico, Republic of Moldova, Monaco, Montenegro, Morocco, Oman, Pakistan, Occupied Palestinian Territory, Philippines, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, South Africa, Thailand, Tunisia, Ukraine, United Arab Emirates, Uruguay and Vietnam.

Note: The data presented above was extracted from EudraGMDP on 13th January 2016. Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2015 EMA/INS/GMP/146965/2015

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The draft 2016 EMA re-inspection programme was circulated for comments to the EEA competent authorities in September 2015. The final programme was agreed at the November 2015 meeting of the GMP/GDP IWG for adoption by CHMP and CVMP.

4. Mutual recognition agreements (MRAs) and other agreements on GMP 4.1. MRA General A joint MRA partners meeting organised by the Australian TGA took place in Indonesia in October 2015 in the margins of the PIC/S Committee of Officials meeting.

4.2. MRA with Japan 3 Japanese observers attended the March 2015 GMP/GDP IWG meeting. A Japanese visiting expert from the Ministry of Health, Labour and Welfare (MHLW) attended the GMP/GDP IWG meetings in September and November 2015. Work on the MRA extension to all Member States, active substances, sterile and biological products continued throughout 2015.

4.3. MRA with Canada An observer from Health Canada attended the March 2015 GMP/GDP IWG meeting. Work on the MRA extension to include new Member States continued in 2015. Work on the Comprehensive Economic Trade Agreement (CETA) continued throughout 2015.

4.4. MRA with Switzerland Swiss observers attended all four GMP/GDP IWG meetings in 2015 and proactively shared the minutes of the Swiss Inspectorates Coordinating Committee (ICC).

4.5. MRA with Australia The Australian TGA began entering information into EudraGMDP.

4.6. MRA with New Zealand There were no changes to the existing MRA co-operation with New Zealand throughout 2015.

4.7. ACAA with Israel An observer from Israel attended two GMP/GDP IWG meetings in 2015.

4.8. Other international collaborations on GMP Support for work in the context of the EU-US Mutual Reliance Initiative (MRI) continued in 2015. The EU MRI team performed an audit of the US FDA system in September 2015.

Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2015 EMA/INS/GMP/146965/2015

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GMP/GDP IWG agreed on a number of specific measures to enhance collaboration with the Indian regulatory authorities. The GMP/GDP IWG was regularly informed about GMP-related activities linked to the International Coalition of Medicines Regulatory Authorities (ICMRA). EDQM attended all four GMDP IWG meetings in 2015 as an observer.

5. Harmonisation topics 5.1. Joint Audit Programme (JAP) JAP audits of inspectorates in Greece, Germany, Croatia-h, United Kingdom-h, Czech Republic-h, Hungary-h, Italy-h and Italy-v took place in 2015. With the exception of the audit of the Italian veterinary inspectorate, US FDA observed these audits in the context of the EU-US MRI. Work continued on updating JAP procedures to introduce risk-based approaches. The JAP audit schedule 2016-2021 was adopted in November 2015 by GMP/GDP IWG.

5.2. Compilation of Union Procedures on Inspections and Exchange of Information GMP/GDP IWG decided there was no need to develop a specific inspection report format for use in inspections of active substance manufacturers. Work continued towards the development of a new Union procedure for handling GDP non-compliance in 2015.

6. GMP and GDP guidance GMP guidelines are developed in collaboration with PIC/S in accordance with the EMA-PIC/S cooperation agreement.

6.1. GMP Guide: Chapter 3 (Premises and Equipment) and Chapter 5 (Production) Revised Chapter 3 and Chapter 5 were phased into operation with effect from 1 March 2015. GMP/GDP IWG established an implementation team with input from the Safety Working Party (SWP) for the science and risk-based approach to the manufacture of different products using shared facilities.

6.2. GMP Guide: Chapter 8 (Complaints, Quality Defects and Product Recalls) A revised Chapter 8 came into operation on 1 March 2015.

Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2015 EMA/INS/GMP/146965/2015

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6.3. GMP Guide: Annex 1 (Manufacture of Sterile Medicinal Products) A concept paper on the revision of Annex 1 was published for consultation until 30 March 2015. The revised Annex will also address the use of non-distillation methods for the production of water for injections (WFI). Q&As were developed with a view to publishing early guidance on this topic.

6.4. GMP Guide: Annex 13 (Manufacture of Investigational Medicinal Products) In light of the upcoming EU Clinical Trial Regulation (EU) No 536/2014, the detailed guidelines on GMP for Investigational Medicinal Products (IMPs) will no longer take the form of an Annex. Draft detailed guidelines on GMP for IMPs were published by the Commission for public consultation until 24 November 2015.

6.5. GMP Guide: Annex 15 (Qualification and Validation) A revised Annex 15 was published and came into operation on 1 October 2015.

6.6. GMP Guide: Annex 16 (Certification by a Qualified Person and Batch Release) A revised Annex 16 was published with a deadline for coming into operation on 15 April 2016.

6.7. GMP Guide: Annex 17 (Real Time Release Testing) An updated draft Annex 17 was published for public consultation until 11 December 2015.

6.8. GMP for importers of medicinal products (“Annex 21”) A concept paper was published for consultation until 29 August 2015.

6.9. EudraGMDP database Training on the use of EudraGMDP, including how to upload information into the planning module, was provided to EDQM in June 2015 and to EEA competent authorities and Swissmedic in September 2015.

6.10. Q&A Work was carried out on a number of Q&As with a view to harmonising interpretation and expectations on a number of GMP topics. The following were published on the EMA website in 2015: •

Q&As on inspection of biological API manufacturers



Q&As on metal detectors



Q&As on verification of the supply chain

Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2015 EMA/INS/GMP/146965/2015

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7. Collaboration with the European Commission New legislative developments were monitored to assess and advise on the potential impact on GMP, GDP, inspections or inspection-related activities. In particular, attention was paid to developments related to clinical trials, advanced therapy medicinal products and veterinary medicinal products. The GMP/GDP IWG provided feedback on the draft guidelines on GMP for Advanced Therapy Medicinal Products, whose targeted consultation was launched by the European Commission until 12 November 2015. The GMP/GDP IWG was consulted on the new draft Delegated Regulation laying down the principles and guidelines on GMP for IMPs, whose public consultation was launched by the European Commission until 24 November 2015.

8. Liaison with other groups The GMDP IWG maintained dialogue and monitored developments involving external groups in areas of common interest. The aim was to communicate the work of the Group and to assess the impact of other groups’ activities on GMP/GDP guidance, the Compilation of Union Procedures and other inspection-related activities. Particular attention was paid to supporting collaborative activities aimed at optimising the use of inspection resources and capacity building.

8.1. International Conference on Harmonisation (ICH) The GMP/GDP IWG was consulted on a number of topics in connection with the development of ICH Q12 (Lifecycle Management).

Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2015 EMA/INS/GMP/146965/2015

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