Consultation: Draft Guidance on Process Validation: Terminal Sterilization Processes for Pharmaceutical Products (GUI-0074)

The online consultation is now closed. The content found on this page is a snapshot of the live consultation as it was presented to the public and contains the content that was open for submissions during the consultation period. The new guides will be posted when the documents are finalized.

Background

The draft guidelines outlined in Guidance on Process Validation: Terminal Sterilization Processes for Pharmaceutical Products (GUI-0074) apply to the validation of sterilization of raw materials, packaging materials, and finished products for pharmaceutical and veterinary drugs.

This guidance was revised to reflect the current regulatory environment and to clarify certain aspects that have relevance to the validation of terminal sterilization processes.

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 being consulted on Guidance on Process Validation: Terminal Sterilization Processes for Pharmaceutical Products (GUI-0074), has been reviewed as part of the Inspectorate program's quality management process and has been amended accordingly. Highlights of the major changes to the document are as follows:

• This one document replaces the previous version of Process Validation: Gaseous Sterilization for Pharmaceuticals (GUI-0007), Process Validation: Irradiation Sterilization for Pharmaceuticals (GUI-0009) and Process Validation: Moist Heat Sterilization for Pharmaceuticals (GUI-0010).
• It contains three new sections on product definition, sterilizing agent characteristics, and process definition for all three sterilization methods.
• A new section on equipment specification.

How to Get Involved and Deadline

The consultation period is open for comments and suggestions for 30 days, starting December 16, 2011 until January 16, 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 30 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