ARCHIVED - Consultation: Draft Documents for Drug Good Manufacturing Practices (GMP) Inspection Program (GUI-0001 Related)

Unanticipated circumstances have caused delays in the posting of some information online. Notification of documents available "for comment" will be posted online and the actual documents will be released upon request.

Comments are Requested on the Following Draft Document:

• Annex 4 to the Current Edition of the Good Manufacturing Practices Guidelines Veterinary Drugs (GUI-0012)
  • The document was previously known as "Veterinary Drugs Annex to Current Edition of the Good Manufacturing Guidelines (GUI-0012)" 2003 version.
  • A new section (Section 2) has been added in order to provide guidance on non-prescription, non-sterile veterinary drugs that require no withdrawal period at the highest dosage in each species for which they are approved.
  • Some interpretations were added and some interpretations were renumbered in order to correspond with changes to Good Manufacturing Practices (GMP) Guidelines, 2009 edition (GUI-0001).

• Risk Classification of GMP Observations (GUI-0023), 2009 Edition
  • The list of observations was reorganized according to GMP regulations, instead of according to risk.
  • Examples of observations were added based on the changes to Manufacturing Practices (GMP) Guidelines, 2009 edition (GUI-0001).
  • Examples of observations were added under certain GMP Regulations for which there were no examples previously (e.g., two examples for Risk 3 observations were added under Personnel C.02.006).

• Annex 3 to the Current Edition of the Good Manufacturing Practices Guidelines Schedule C (Radiopharmaceutical) Drugs (GUI-0026)
  • New interpretations were added under the following sections: Personnel, Raw Material Testing, Quality Control Department, Finished Product Testing, Stability, and Sterile Products.
  • Separate sections for the purpose and the scope were added.
  • The glossary of terms was moved to the end of the document as an appendix.
  • The mandate on the cover page was updated.
  • A disclaimer was added.
  • The document was re-formatted.

• Annex 2 to the Current Edition of the Good Manufacturing Practices Guidelines Schedule D Drugs (Biological Drugs) (GUI-0027)
  • The document's name has changed. It was previously known as "Good Manufacturing Practices for Schedule D Drugs, Part 1, Biological Drugs including fractionated blood products", 1999 version.
  • Some interpretations were added and some interpretations were renumbered to correspond with changes to Good Manufacturing Practices (GMP) Guidelines, 2009 edition (GUI-0001).
  • The introduction of the document was modified.
  • Interpretation of GMP requirements for the collection and processing of human blood and blood components are not within the scope of this guidance.

• Annex 1 to the Current Edition of the Good Manufacturing Practices Guidelines for Selected Category IV Monograph Drugs (GUI-0066)
  • There are no major changes

Please see below to comment on all 5 consultations.

How to Get Involved

All five consultations below are open for comment for 90 days, starting August 7, 2009 until November 5, 2009.

To request documents: Interested stakeholders who wish to provide comments may contact the Drug Good Manufacturing Practices Inspection Unit to request an electronic copy or alternate format of any of the documents.

Please include in the subject line, the title and the preferred language of the consultation document you wish to receive.

Comments are Requested on the Following Draft Documents:

• Annex 4 to the Current Edition of the Good Manufacturing Practices Guidelines Practices Guidelines Veterinary Drugs (GUI-0012)
• Risk Classification of GMP Observations (GUI-0023), 2009 Edition
• Annex 3 to the Current Edition of the Good Manufacturing Practices Guidelines Schedule C (Radiopharmaceutical) Drugs (GUI-0026)
• Annex 2 to the Current Edition of the Good Manufacturing Practices Guidelines Schedule D Drugs (Biological Drugs) (GUI-0027)
• Annex 1 to the Current Edition of the Good Manufacturing Practices Guidelines for Selected Category IV Monograph Drugs (GUI-0066)

Comments received from stakeholders and interested parties will be reviewed after the 90
day comment period.

Interested parties are encouraged to provide comments and suggestionsby November 5, 2009 on any of the above documents.

Reporting to Canadians

Health Canada will make the results of this consultation available on this Web site.

If you have any questions, contact us at Drug Good Manufacturing Practices Inspection Unit.

Yours truly

Original signed by

Diana Dowthwaite
Director General