Two issues stand out from the usual subjects: European inspectors see the need for guidance on data integrity and on the implementation of cross-contamination risk management in shared manufacturing facilities for industry as well as for inspectorates.
GMP topics of interest identified for 2016:
Implementation of GMP guidance on the use of cross-contamination risk management in shared manufacturing facilities for the manufacture of different medicinal products
- To establish an EU implementation team.
- To develop and implement an appropriate supervision plan for the heparin supply chain in consultation with international partners.
- To harmonise practices in relation to the listing of products or active substances in GMP Certificates.
GMP for biological active substances
- To harmonise GMP expectations in view of the differing levels of detail between Parts I and II of the GMP Guide.
- To develop principles for inspectorates when dealing with findings of non-compliance due to data integrity issues or when dealing with reports of non-compliance due to data integrity issues issued by authorities from third countries.
GMP and GDP topics
To continue to identify GMP and GDP topics for guideline development or clarification.
GMP Guide: Chapter 1 (pharmaceutical quality system)
- To decide on whether to proceed with a proposal to amend the chapter in order to capture the main principles of the industry inter-association shortages taskforce guidelines aimed at reducing shortages caused by quality/manufacturing problems.
GMP Guide: Chapter 4 (documentation)
- To consider whether amendments are required in order to assure data integrity in the context of GMP. Early guidance in the form of Q&As will also be considered.
GMP Guide : Annex 1 (sterile products)
- To provide a draft text for public consultation;
- To adopt and publish advance Q&As dealing with the production of Water for Injections by Reverse Osmosis and control of biofilms.
GMP Guide: Annex 17 (parametric release)
- To finalise the revision aimed at updating this annex.
GMP Guide: annex 21 (New: Importation of medicinal products)
- To provide a draft text for public consultation.
GMP Guidance on Data Integrity
- To clarify data integrity expectations in relation to GMP including whether short term measures should be developed followed by longer term measures.
To continue to collaborate with the European Commission and the Committee for Advanced Therapies (CAT) on the proposal for development of GMP guidance for advanced therapy medicinal products.
GMP compliance and Marketing Authorisation Holders
- To develop a Reflection Paper on the relationship between GMP Compliance and the responsibilities and activities of Marketing Authorisation Holders.
EMA: What's New?