The European Medicines Agency is responsible for coordinating inspections to verify compliance with the principles of good manufacturing practice (GMP), good clinical practice (GCP), good laboratory practice (GLP) and good pharmacovigilance practice (GVP). Inspections also verify compliance with other aspects of the supervision of authorised medicinal products in use in the European Union. These are described in Regulation (EC) 726/2004, in Directive 2001/83/EC and in Directive 2001/82/EC.
The Agency is responsible for coordinating any inspection requested by the Committee for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP) in connection with the assessment of marketing-authorisation applications or matters referred to these committees.
These inspections may cover GCP, GLP, GMP, GVP or vaccine antigen master file (VAMF) or plasma master file (PMF) certification. They may be necessary to verify specific aspects of the clinical or laboratory testing or manufacture and control of the product or to ensure compliance with GMP, GCP, GLP or pharmacovigilance quality assurance systems.
The Agency organises and chairs regular meetings of GCP, GVP and GMP inspectors from the European Economic Area (EEA). These meetings:
- develop harmonisation of inspection-related procedures and guidance documents;
- manage the Agency's process analytical technology (PAT) team. This is a forum for dialogue and understanding between the Quality Working Party, Biologics Working Party and the GMP / GDP Inspectors Working Group, with the aim of reviewing the implications of PAT and quality by design.
Sampling and testing
- GCP compliance
- GLP compliance
- GMP / GDP compliance
- PMF inspections
- VAMF inspections
- Sampling and testing
- Mutual-recognition agreements
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