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Home Policy & Regulation News Rx-360 summary of the EMA work plan for GMP/GDP Inspectors Working Group for 2016
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4 Feb 2016

Rx-360 summary of the EMA work plan for GMP/GDP Inspectors Working Group for 2016

Highlights include inspections, MRAs, harmonization efforts amd GMP/GDP guidance.

EMA has recently issued its 2016 Work Plan for the GMP/GDP Inspectors Working Group. Highlights include the following:

Inspections

  • EMA will continue to make the best use of EU inspection resources by leveraging information from international regulatory authority partners wherever possible and implementing other risk-based approaches agreed to in EU procedures.

    • Mutual Recognition Agreements (MRAs)

  • MRA activities continue with Canada, Japan, Switzerland, Australia, New Zealand, Israel, India, and the US. This includes integration of Japan and Canada into the International API Inspection Program and training of India regulators on EU GMP standards.
  • Efforts continue to encourage and facilitate the use of the EudraGMDP dB by MRA partners to replace the paper exchange of GMP certificates.
  • Collaboration with FDA will continue so next steps necessary to achieve the EU-U.S. Mutual Recognition Initiative (MRI) goals can be identified.

    • Harmonization Efforts

  • Regarding the Joint Audit Programme - EMA will continue to adopt and implement risk-based audit procedures, monitor the results of audits, and collaborate with PIC/S and MRA partners in joint audits.
  • The Work Plan includes the establishment of an EU implementation team to address the GMP guidance on use of cross-contamination risk management in shared manufacturing facilities for the manufacture of different medicinal products.
  • Data Integrity: There are plans 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.
  • The Working Group will be focusing on plans for assessing the impact of the EU Clinical Trials Regulation on GMP inspections, as well as the guidelines on GMP for IMPs for human use.

    • GMP/GDP Guidance

    The following documents are planned to be issued:

  • Chapter 1: Determine whether to proceed with a proposal to amend this chapter to capture the main principles of the industry inter-association drug shortages taskforce guidelines to reduce shortages caused by quality/manufacturing issues.
  • Chapter 4: Determine whether amendments are needed to assure data integrity in the context of GMP - early guidance (Q&As) will also be considered.
  • Annex 1: Issue a draft for public consultation, and publish advance Q&As on WFI by RO and control of biofilms.
  • Annex 17: Finalize the revision to update this annex (the draft revision has already been issued for public consultation).
  • Annex 21 (new - Importation of Medicinal Products): Issue a draft for public consultation.
  • GMP Guidance on Data Integrity: Clarify data integrity expectations in related to GMP including whether short term measures should be developed followed by longer term measures.

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