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Drugs and Health Products
Notification: Release of Final Versions of Documents - Drug Good Manufacturing Practices (GMP) Inspection Program
The unanticipated circumstances that caused a delay in the web posting of this final version document have been resolved. This document is now available online.
The following documents are released as final versions:
- Validation Guidelines for Pharmaceutical Dosage Forms (GUI-0029)
- This document has been reviewed as part of the Inspectorate's quality management process and has been amended to further clarify issues brought to the attention of the Inspectorate.
- There are no changes to the requirements.
- Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines - Drugs Used in Clinical Trials (GUI-0036)
- This document has been reviewed as part of the Inspectorate's quality management process and has been amended to further clarify issues brought to the attention of the Inspectorate.
- Sections 26 to 32 have been replaced with the text from section C.05.011 of the Food and Drug Regulations.
- Additional guidance has been provided regarding expiry dates (Section 26).
- Summary Report of the Post-Market Reporting Compliance Inspections of Drug Manufacturers Conducted from September 1, 2005 to March 31, 2008
- This document provides the results, examples and an analysis of findings of Post-Market Reporting Compliance (PMRC) inspections of drug manufacturers conducted from September 1, 2005 to March 31, 2008, by the Health Products and Food Branch Inspectorate (Inspectorate).
If you have any questions, contact us at Drug Good Manufacturing Practices (GMP) Inspection Unit.
Yours Truly
Original signed by
Diana Dowthwaite
Director General
