Inspections - Good Manufacturing PracticeInspections - Good Manufacturing Practice
Compilation of Community Procedures on Inspections and Exchange of Information
The EMEA is responsible for maintaining and publishing the Compilation of Procedures on behalf of the European Commission. The Compilatio...
Inspections - Good Manufacturing Practice
Compilation of Community Procedures on Inspections and Exchange of Information
The EMEA is responsible for maintaining and publishing the Compilation of Procedures on behalf of the European Commission. The Compilation of Procedures is a collection of GMP inspection- related procedures and forms agreed by the GMP inspectorates of all the Member States and designed to facilitate administrative collaboration, harmonisation of inspections and exchange of inspection-related information. Article 3 of the GMP Directive, 2003/94/EC, requires Member States to take account of these procedures, and they are used as the basis for standard operating procedures of the quality systems established within the inspectorates themselves.
Zip file containing all the documents in the Compilation (file size = 1.4 MB)
Individual documents can be downloaded using the links below:
Table of Contents and Introduction:
Quality Systems Framework for GMP Inspectorates
Procedures related to Rapid Alerts:
Handling of reports of suspected quality defects in medicinal products
Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects
Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects pending adoption
Rapid Alert Notification form
Rapid Alert Follow up form
Procedures related to GMP Inspections:
Procedure for dealing with serious GMP non-compliance or voiding/suspension of CEPS thus requiring coordinated administrative action pending adoption
Conduct of Inspections of Pharmaceutical Manufacturers
Outline of a Procedure for Co-ordinating the Verification of the GMP status of Manufacturers in Third Countries
Guideline on Training and Qualifications of GMP Inspectors
Exchange of Information on Manufacturers and Manufacturing or Wholesale Distribution Authorisations between Competent Authorities in the European Economic Area
Exchange of Information form - Appendix 1 (request for information)
Exchange of Information form - Appendix 2 (reply form)
Guidance on the occasions when it is appropriate for Competent Authorities to conduct inspections at the premises of Manufacturers of Active Substances used as starting materials
The issue and update of GMP certificates
A model for risk based planning for inspections of pharmaceutical manufacturers
Forms used by Regulators:
GMP Inspection report - Community format
HYPERLINK "http://www.emea.europa.eu/Inspections/docs/CoCP/CoCP_GMPInspReport.pdf"
Community Basic Format for Manufacturers Authorisation
GMP Certificate corr.
Procedures related to Centralised Procedures:
Procedure for Co-ordinating Foreign and Community Pre-Authorisation Inspections during the Assessment of Applications
Guideline on the Preparation of Reports on GMP Inspections Requested by either the CHMP or CVMP in connection with Applications for Marketing Authorisations and with Products authorised under the Centralised System
Delegation of Responsibilities for GMP Inspections for Products covered under the Centralised Procedure
Compilation History:
History of changes to Compilation of Procedures
Send all queries regarding this content to: gmp@emea.europa.eu
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