- Tous > Quality and Safety: Medicines > Quality Assurance
- Tous > Quality and Safety: Medicines > Regulatory Support
- Tous > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Mots-clés > desk assessment by NRAs - compliance with GMP, GLP, GCP, etc.
- Mots-clés > good documentation practices (GDocP)
- Mots-clés > Good Manufacturing Practices (GMP)
- Mots-clés > information compliance - good practices in manufacturing, quality control and clinical trials
- Mots-clés > information exchange
- Mots-clés > inspection - NRAs documentation, reports and records
- Mots-clés > inspection report
- Mots-clés > marketing authorization
- Mots-clés > post marketing surveillance
- Mots-clés > registration - Collaborative Registration Procedure (CRP)
(2018; 38 pages)
This guidance aims at providing an approach for use by NRAs for assessing compliance with GMP, GLP or GCP using documentation issued by other NRAs in lieu of conducting an inspection of a specific site.
The use of the desk assessment as described in this guidance is intended to provide a way to reduce the necessity for duplication and the frequency of inspections while relying on authentic and reliable documentary evidence from other regulatory authorities. Desk assessment should also reduce the inspection resources needed by both the manufacturing site and the NRAs and result in broader availability of high-quality medicinal products to patients globally. It may also be used by NRAs for continuous evidence-based regulatory decisions and follow-up on quality assurance issues that go beyond marketing authorization.
The guidance also lists the key documents to be submitted by other regulatory authorities and/or manufacturers that provide reliable information about the status of compliance with good practices in manufacturing, quality control and clinical trials of a specified medical product. The essential information and documents that need to be available to conduct the desk assessment in relation to the most relevant GxPs, in this context GMP, GLP and GCP, are described.
The objective of this guidance is to:
- ensure that a standardized procedure is followed for desk assessment of inspection documentation and reports issued by trusted, competent regulatory authorities and of records of corrective actions from inspected sites;
- facilitate a convergent approach and model for exchange and use of inspection information in national and regional decision making concerning the necessity to perform preapproval and surveillance inspections.