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Consultation: Cleaning Validation Guidance (GUI-0028)

Background

The Cleaning Validation Guidance provides some guidance on issues and topics related to validation of equipment cleaning for the removal of contaminants associated with previous products, residues of cleaning agents as well as the control of potential microbial contaminants for pharmaceutical, biological and radiopharmaceutical products. Utilization of this information should facilitate compliance with Division 2 Part C of the Food and Drugs Regulations.

This guidance document was revised to reflect the current regulatory environment and to add an Appendix which provides concrete examples of cleaning calculations to establish maximum allowable carryover limits based on therapeutic dose.

The Good Manufacturing Practices (GMP) guidelines are available on Health Canada's Compliance and Enforcement website (www.health.gc.ca/gmp).

Information on the Document

The document under consultation, Cleaning Validation Guidance (GUI-0028), has been reviewed as part of the Inspectorate program's quality management process and has been amended. Highlights of the major changes to the document are as follows.

• The inclusion of a more detailed description of cleaning parameters.
• The update of the section outlining requirements for carryover of product residue.
• The addition of an Appendix exemplifying the calculation of carryover limits.
• Other administrative changes, including minor changes based on the Good Manufacturing Practices (GMP) Guidelines - 2009 Edition, Version 2 (GUI-0001).

How to Get Involved and Deadline

The consultation period is open for comments and suggestions for 90 days, starting December 16, 2011 until March 15, 2012.

• To request the document: Interested stakeholders who wish to provide comments may send a request for an electronic copy or alternate format of the document to GMP_questions_BPF@hc-sc.gc.ca.
• Please include in the subject line, the title and the preferred language of the consultation document you wish to receive.
• Comments received from stakeholders and interested parties will be reviewed after the 90 day comment period.

Reporting to Canadians

Health Canada will make the results of this consultation available on this website. Any questions or comments should be addressed to GMP_questions_BPF@hc-sc.gc.ca.

Yours truly,
Diana Dowthwaite
Director General