IMPs: Four new public consultations concerning GMP and GCP published

The EU Commission has published four new public consultations on Investigational Medicinal Products (IMPs). They concern both good manufacturing practices (GMP) and clinical trials (GCP) for human medicinal products:

1.) Commission Delegated Act on principles and guidelines on good manufacturing practices for investigational medicinal products for human use and inspection procedures

2.) Detailed Commission guidelines on good manufacturing practices for investigational medicinal products

3.) Commission Implementing Act on principles and guidelines on good manufacturing practice for medicinal products for human use

4.) Detailed arrangement for clinical trials inspection procedures including the qualifications and training requirements for inspectors

The EU Commission states that because "good manufacturing practice for investigational medicinal products for human use already exists and is generally well-functioning, there is no need to reinvent the wheel". So the GMP related consultation documents carry over elements set out in Directive 2003/94/EC relating to investigational medicinal products for human use. Or the documents refer, when relevant, to specific parts, chapters or annexes of EudraLex Volume 4. The reason is that once Regulation (EU) No 536/2014 on clinical trials becomes applicable, manufacture and import of IMPs for the use in clinical trials carried out under that Regulation cannot follow GMP for IMPs set out in Directive 2003/94/EC. They then have to be manufactured or imported under regulations laid down by the Delegated Act or other specified regulation.

The first one (the Commission Delegated Act) wants to collect views and information from stakeholders to help developing the final delegated act. Therefore, overall eight questions are asked in the document (e.g. on the handling of the Product Specification File or retention/ reference samples).
Quite new is the call for regulatory inspections of IMP manufacturers located in third countries. Those sites would have to comply with GMP at least equivalent to EU-GMP. Otherwise an import allowance could be suspended.

The detailed Commission guidelines complement the rather high-level principles and guidance of the Delegated Act and aim to provide more detail. Although not directly in the scope of these guidelines, it does also address a few issues concerning auxiliary medicinal products and reconstitution. However the expectations are not really new.
Some highlights are:

  • CAPA would be further introduced in IMP manufacturing: "Deviations from any predefined specifications and instructions shall be investigated and corrective and preventive action (CAPA) measures initiated."
  • Change Control: full control and traceability of changes to product specifications and manufacturing instructions should be maintained. Rationales for changes should be documented together with possible consequences on product quality and on any on-going clinical trials.
  • Guidance on the need to minimise all risks of cross-contamination.
  • Content and extend of the Product Specification File (PSF)
  • Control and documentation of development steps and batches.
  • Guidance on blinding, packaging and labelling operations incl. the necessary quality control.
  • The role of the Qualified Person and provisions for batch release.
  • All complaints should be documented and assessed to establish if they represent a potential quality defect or other issue.
  • The handling of recalls and returns

The detailed arrangement for clinical trials inspection procedures are valid for inspectors performing inspections of clinical trials conducted in the EU and in third countries. Besides discussing the necessary qualification, training and experience the document clarifies how an inspector can prove the absence of conflicts of interest. Inspectors shall "sign a statement declaring any financial or other links to the parties to be inspected".

The consultation period ends on 24 November 2015. More details can be found in the How to submit your contribution section.

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