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1 sie 2024 · The European Medicines Agency (EMA) maintains a compilation of inspection-related procedures and templates used by the good manufacturing practice (GMP) and good distribution practice (GDP) inspectorates in the European Union (EU) and European Economic Area (EEA).
- Good manufacturing practice | European Medicines Agency (EMA)
Good manufacturing practice (GMP) describes the minimum...
- Guideline on training and qualifications of GMP inspectors
Taking into account its importance for the management of...
- Good manufacturing practice | European Medicines Agency (EMA)
Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level.
Taking into account its importance for the management of inspection services, this guideline establishes requirements concerning experience, training and qualifications of GMP inspectors. Objectivity, professional integrity, competence in technical matters and inspection skills should be the main features of inspectors.
The purpose of this document is to provide guidance on the conduct of inspections to harmonise inspection procedures, frequency of inspections and follow-up procedures thus ensuring a consistent approach to assessment and decision-making by Competent Authorities.
The EDQM inspections are normally carried out by teams composed of an official inspector from the EU/EEA competent authorities (or from countries having a Mutual Recognition Agreement (MRA) with the EU in the sector of GMP for APIs) and an inspector from EDQM. They typically last 3 days.
The purpose of this document is to provide guidance on the conduct of inspections to harmonise inspection procedures, frequency of inspections and follow-up procedures thus ensuring a consistent approach to assessment and decision-making by Competent Authorities.
2.2 Each GMP national inspection service should use this document as the basis for developing its own quality system, so that inspection activities within each inspection service are carried out in accordance with a system compatible with those of the other member states.
