Draft EU GMP guide calls for supply chain traceability of starting materials
This article was originally published in SRA
The European Commission has proposed changes to its good manufacturing practice guideline for human and veterinary-use pharmaceuticals1. Specifically, it has suggested revisions to chapters five and seven of the GMP guide relating to production2 and outsourcing3 activities, respectively.
Stakeholders have until 28 February to submit feedback on the draft documents that will replace the existing chapters4,5 in the GMP guide after they are finalised.
Production
The changes proposed to the chapter on production-related GMP requirements "contain some explosive material," says Sven Pommeranz in an article for the European Compliance Academy, an independent European association on pharmaceutical quality assurance and GMP compliance6.
Among other things, the commission has suggested revisions to the sections on the qualification of suppliers of starting materials to reflect the legal obligation of manufacturing authorisation holders to ensure that active substances are produced in accordance with the GMP requirements.
Also, a new requirement has been introduced on supply chain traceability of starting materials. The commission wants the suppliers of active substances, and certain excipients considered to be high-risk materials used as starting materials, to be periodically audited to confirm that they comply with current GMP requirements. The findings from each audit, it says, should be documented and audit reports should be made available for review by inspectors.
For each delivery, the commission wants the containers to be checked for integrity of the package and seal, and for correspondence between the delivery note and the supplier's labels. Verification of the supply chain traceability should also be established and documented. Mr Pommeranz points out that the requirement to assess the starting material's supply chain is new "and depending on the supplier, the implementation will perhaps not be that simple".
Additionally, a new section has been added to the guide in order to clarify and harmonise the expectations of manufacturers regarding the testing of starting materials.
Outsourcing activities
The chapter on "contract manufacture and analysis" in the GMP guide has been revised to harmonise its provisions with the requirements of the International Conference on Harmonisation's Q10 guideline on pharmaceutical quality systems.
The revised chapter, re-titled as "outsourced activities", holds the contract giver responsible for assessing the legality, suitability and the competence of the contract acceptor and, if applicable, mutually agreed subcontractors, to carry out successfully the outsourced activities. This assessment, it says, must be made prior to outsourcing activities.
EMA proposes changes to chapter on quality control
Separately, the European Medicines Agency is proposing revisions to chapter six of the GMP guide, which provides guidance on the quality control department and good quality control laboratory practice7. The agency has developed a draft concept paper on the topic and recommends that a new section be developed to provide guidance to industry and inspectors for the transfer of analytical methods from one laboratory to another.
Stakeholders have until 28 February to submit feedback on the EMA's draft.
References
1. European Commission, Medicinal Products for Human Use: Latest Developments, 9 November 2010, http://ec.europa.eu/health/human-use/latest_updates/index_en.htm
2. European Commission, Public consultation of the revised chapter 5 of the GMP laying down the detailed guidelines for production, 9 November 2010, http://ec.europa.eu/health/human-use/latest_updates/index_en.htm
3. European Commission, Public consultation of the revised chapter 7 of the GMP laying down the detailed guidelines for outsourcing activities, 9 November 2010, http://ec.europa.eu/health/files/gmp/chap7_for_pc_en.pdf
4. GMP Guide, Chapter 5: Production, Site accessed November 2010, http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/cap5en.pdf
5. GMP Guide, Chapter 7: Contract Manufacture and Analysis, Site accessed November 2010, http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/cap7en_en.pdf
6. ECA, GMP News: European Commission issues new Draft of Chapter 5 "Production" of the EU GMP Guide, 25 November 2010, www.gmp-compliance.org/eca_news_2288_6804,6741,6748,6862,6786.html
7. EMA, Draft concept paper on the revision of chapter 6 of the EU GMP guide quality control, 23 November 2010, www.ema.europa.eu/ema/doc_index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500099260&murl=menus/news_and_events/news_and_events.jsp&mid=0b01ac058009a3dc