Archived Notice to stakeholders - Release of draft guidance documents for consultation: Cleaning validation guide (GUI-0028) and Guide to validating drug dosage forms (GUI-0029)

November 20, 2018

Health Canada is pleased to announce the release of two draft guidance documents for a 90 day stakeholder consultation from November 20 to February 20, 2019:

• Cleaning validation guide (GUI-0028)
• Guide to validating drug dosage forms (GUI-0029)

These revised guidance documents contain new information. Plain language principles to make the documents easier to read and understand have been considered in rewriting and formatting the documents. They will continue to support compliance with good manufacturing practice requirements prescribed in Part C, Division2 of the Food and Drug regulations (FDR).

The key changes are listed below.

How to participate

1. Obtain documents

Please email hc.hpil.consultation-ipsop.sc@canada.ca to receive copies of:

• Each draft guidance document, and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

2. Submit Comments

Please email your comments to hc.hpil.consultation-ipsop.sc@canada.ca using one comment form for each guidance document. All comments will be considered in the finalization of the documents. The 90-day consultation period is from November 20 to February 20, 2019 inclusively.

Comments can also be mailed to:

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

The Health Canada guidance documents have been rewritten and formatted using plain language principles to make the documents easier to read and understand. This is in conformance with requirements for migration of documents to the Canada.ca website.

GUI-0028 Cleaning Validation Guide for drug products is applicable to all in pharmaceutical, biological and radiopharmaceutical manufacturing in Canada, including: fabricators, packagers/labelers, testers, importers, distributors and wholesalers including inspectors and evaluators and regulated industry. Please note that for GUI-0028 a previous external consultation was conducted from December 16, 2011 until March 15, 2012. External and internal consultation comments were considered and addressed as appropriate. It was recognized that the content needed additional revisions since the 2012 consultation, therefore, this consultation will provide stakeholders with the opportunity to provide further input to the document. Changes include:

• Updates to principles and analytical methods.
• New sections on Quality Risk Management (QRM), cleaning validation master plan and cleaning validation lifecycle approach, microbial controls, and general equipment cleaning,
• Considerations for cleaning of active pharmaceutical ingredient (API) production processes and cleaning validation of Biotechnology processes.

GUI-0029 Guide to validating drug dosage forms is applicable to all pharmaceutical, biological and radiopharmaceutical manufacturing in Canada, including: fabricators, packagers/labelers, testers, importers, and distributors. Changes include:

• Updates to general format of the guide.
• New sections on life cycle approach to validation programs, guidance related to analytical method validation and equipment/facility qualification.