Notice to stakeholders – Release of draft guidance document for consultation: Annex 3A to the Good Manufacturing Practices Guide 

October 7, 2020

Health Canada is pleased to announce the release of Annex 3A to the Good manufacturing practices guide – Schedule C drugs (GUI-0026) for a 150-day stakeholder consultation period from October 7, 2020 to March 6, 2021.

This revised guidance document contains new information with key changes listed below.

This guide is an annex to the Good manufacturing practices guide for drug products (GUI-0001) and Good manufacturing practices (GMP) guidelines for active pharmaceutical ingredients (API) (GUI-0104). These guides are intended to be read together and will help you understand and comply with Part C, Division 2, of the Food and Drug Regulations (the Regulations), regarding good manufacturing practices (GMP).

How to participate

1. Obtain documents

Email hc.hpil.consultation-ipsop.sc@canada.ca to receive copies of the:

• draft guidance document; and
• comment form for your submission of comments by section number and line number.

2. Submit comments

Email your comment form to hc.hpil.consultation-ipsop.sc@canada.ca or mail it to the address listed below. All comments will be considered in the finalization of the document. The consultation period is scheduled from October 7, 2020 to March 6, 2021.

Health Product Inspection and Licensing Division
Health Product Compliance Directorate
13th Floor, Jeanne Mance Building
200 Eglantine Driveway, Tunney's Pasture
Address Locator # 1913D
Ottawa Ontario K1A 0K9

Overview of Key Changes

Plain language changes

Key changes to the format and language of GUI-0026 include:

• Placed content in a new document template.
• Added visual call-out boxes for important and reference information.
• Changed wording from passive to active voice.
• Used plain language, where possible, to clarify meanings.
• Shortened sentences and paragraphs.
• Made all headings sentence case.

Technical changes

General

• Changed the title from, "Guidance Document Annex 3 to the Current Edition of the Good Manufacturing Practices Guidelines – Schedule C Drugs" to "Annex 3A to the Good manufacturing practices guide – Schedule C drugs".
• Verified and updated all URLs.
• Updated references to the new version of GUI-0001.
• Added section headings to improve clarity (e.g., About this document, Guidance, and Appendices).

About this document

• Changed the order of the first three sections (so that Purpose and Scope sections come before the Introduction section), and significantly rewrote content.
• Scope − Added a table to explain where GMP may begin and end for both finished dosage forms and active ingredients.
• Introduction – Added an explanation from GUI-0001 regarding how to use guidance documents. Added an explanation of how to use this guide in relation to GUI-0001.

Section 4 – Modified interpretations

• Added a note about numbering not corresponding to GUI-0001.
• Updated references to the new version of GUI-0001.
• 02.025 to C.02.026 – Samples – Improved clarity on requirements for radioactive raw material retention with a change from 3 months to 6 months to better harmonize with international partners. Flexibility was provided to allow alternative periods to be justified.

Appendix A

• Added acronyms to the Glossary.
• Modified several definitions for improved clarity.
• Modified definitions for "Radionuclide" and "Total Radioactivity" to align with a revised version of Annex 3B to the Good manufacturing practices guide – Positron-emitting radiopharmaceuticals (GUI-0071).

Appendix B

• Added a "References" section with full URLs (instead of having to show URLs throughout the document, making text harder to read).
• Added international radiopharmaceutical references from GUI-0071.