News Category: Regulatory news
Updates to the EU Compilation of Union Procedures on Inspections and Exchange of Information were adopted in September 2021 with a period of 9 months before coming into force at the end of June 2022. The changes are relevant for holders of GMP and GDP authorisations.
The Compilation consists of a series of documents that provide the basis for cooperation between GMP and GDP inspectorates of the Members States and as a means of achieving harmonisation. It also includes a procedure that provides the foundation for national GMP/GDP inspectorates quality systems. The Compilation has been restructured into Part I and Part II.
- Part I: Compilation procedures
- Part II: Interpretation documents together with templates.
Updates to Part II are regulatory, apply directly to the work of inspectorates and may not be of immediate relevance to stakeholders. The documents in Part I provide information on the operation of the GMP and GDP network in the event of product quality defects or chronic non-compliance.
Familiarity with these updates may assist applicants’ understanding of regulatory procedures and processes.
Part I
The following documents have been revised in Part I:
- Management of Reports of Suspected Quality Defects in Medicinal Products - the procedure has been revised to provide more comprehensive guidance following quality risk management principles.
- Management of Rapid Alerts Arising from Quality Defects Risk Assessment - the procedure has been revised to provide more comprehensive guidance following quality risk management principles.
- Procedure for dealing with serious GMP non-compliance requiring coordinated measures to protect public or animal health – the procedure has been revised because of experience with the superseded procedure.
- Appendix 6: Supervisory Risk Assessment has been updated.
- Outline of a Procedure for Co-ordinating the Verification of the GMP Status of Manufacturers in Third Countries has been updated.
- A Model for Risk Based Planning for Inspections of Pharmaceutical Manufacturers has been updated.
New in Part I:
- Procedure for compliance management – new procedure
Part II
The following documents have been revised in Part II:
- Interpretation of the Union format for a wholesale distribution authorisation (medicinal products for human use) – new procedure.
- Interpretation of the Union format for GMP certificate has been updated.
- Union Format for a GMP Certificate has been updated.
- The issue and update of GMP certificates – a minor update has been made, primarily to align the procedure with experience.
- Serious GMP Non-Compliance Information - from Third Countries or International Organisations has been updated.
- Statement of non-compliance with GMP Interpretation of the Union Format for Manufacturer/Importer Authorisation has been updated.
New in Part II:
- Interpretation of the Union format for a wholesale distribution authorisation (medicinal products for human use)