Investigational Medicinal Products - Recent Changes in EC Guidance

As we reported before in our IMPs: Four new public consultations concerning GMP and GCP published the implementation of the Clinical Trial Regulation 536/2014 resulted in four new public consultations concerning good manufacturing practices and clinical trials for human medicinal products (opened August 28, 2015) with closing date November 24, 2015.

As a consequence Annex 13 is expected to be deleted from EudraLex Vol 4 when the new guidelines "Detailed Commission guidelines on GMP for IMPs for human use" become operational. It carries over relevant principles of Annex 13.

Basically the ideas are the same. However there is more detail in regard of

  • the pharmaceutical quality system and handling deviations by CAPA
  • supplier approval
  • quality risk management principles
  • final certifying by the qualified person
  • the retaining period of batch records
  • reference and retention samples.

On the European QP Assocaition website you can find a Synopsis of  Annex 13 / "Detailed Commision guidelines for GMP for IMPs for human use". There you will also find a summary which contains links to the most recent changes being published for consultation.

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