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 (following publication) before coming into force i.e. June 2022. The changes are relevant for holders of GMP and GDP authorisations.
The HPRA has provided a timely reminder of these updates.
- 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 as follows:
- Part I: Compilation procedures
- Part II: Interpretation documents together with templates.
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. Updates to Part II are regulatory, apply directly to the work of inspectorates and may not be of immediate relevance to stakeholders.
Familiarity with these updates may assist applicants’ understanding of regulatory procedures and processes.
Further information on this subject is available on page 3 of the HPRA medicinal products newsletter issue no 72.
Part I
| Revised Document | Page No | Reason updated |
|---|---|---|
| Management and classification of reports of suspected quality defects in Medicinal products | Pg 16 | The procedure was revised in order to provide more comprehensive guidance following quality risk management principles. |
| Procedure for managing rapid alerts arising from quality defects risk assessment | Pg 23 | The procedure was revised in order to provide more comprehensive guidance following quality risk management principles. |
| Outline of a Procedure for Co-ordinating the verification of the GMP Status of manufacturers in third countries has been updated | Pg 61 | Updated to include section on reassessment of GMP certificates and modification of the section on the distant assessment procedure. |
| The issue and update of GMP certificates | Pg 80 | Minor update primarily to align with experience |
| A model for risk based planning for Inspections of pharmaceutical manufacturers has been updated | Pg 86 | Minor editorial changes |
| Procedure for dealing with serious GMP non-compliance requiring coordinated measures to protect public or animal health | Pg 108 | Procedure has been revised as a result of experience with the superseded procedure, Appendix 6: Supervisory Risk Assessment has been updated |
Procedure for dealing with serious GMP non-compliance information originating from third country authorities or international organisations | Pg 135 | Minor updates to reflect current practice |
| New document | ||
| Procedure for compliance management | Pg 162 | New procedure |
Part II
| Revised Document | Page No | Reason updated |
|---|---|---|
| Interpretation of the Union format for Manufacturer/Importer Authorisation | Pg 173 | Add further interpretation on the biological testing |
| Interpretation of the Union format for GMP certificate | Pg 190 | Updated to reflect current practice |
| Union format for a GMP certificate | Pg 233 | To reflect current practice |
| Statement of non-compliance with GMP | Pg 241 | To reflect current practice |
| New document | ||
| Interpretation of the Union format for a wholesale distribution authorisation (medicinal products for human use) | Pg 206 | New procedure |
Source: HPRA