Consultation: Draft Guidance on Process validation: Terminal sterilization processes for drugs (GUI-0074)

Current status: Open

Opened on May 3, 2021 and will close to new input on June 2, 2021.

Health Canada is pleased to announce the release of a draft guidance document for a 30 day stakeholder consultation.

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). This document has been previously posted for consultation in 2006 and 2011.

This revised guidance document contains new information. This version incorporates comments received from stakeholders. Plain language principles to make the document easier to read and understand were considered in the review of this guidance document.

This guide is for fabricators of sterile drugs. It will help you validate the terminal sterilization of drugs, including pharmaceutical, radiopharmaceutical, biological and veterinary drugs. The terminal sterilization of drugs refers to sterilizing drugs that are in their final container. The principles set out within this document can be extended to the sterilization of raw materials, bulk materials, in process drugs and packaging materials.

These guidelines were written to align with International Organization for Standardization (ISO) standards. They will help you understand and comply with Good Manufacturing Practices (GMP) prescribed in Part C, Division 2 of the Food and Drug Regulations (FDRs).

Natural Health Products

The principles described in guide 0074 apply to natural health products (NHPs). The Natural Health Products Regulations (NHPR) require that proper Good Manufacturing Practices (GMP) are implemented to ensure that products meet the definition of a sterile product, which could include terminal sterilization. In such cases, manufacturers, packagers, labellers and importers of sterile NHPs should follow the guidance for sterile products provided in the Regulatory Operations and Enforcement Branch's Good Manufacturing Practices for drug products (GUI-0001) in addition to the non-sterile requirements outlined in the Good Manufacturing Practices Guidance Document for the Natural and Non-prescription Health Product Directorate.

Join in: how to participate

The consultation period is open for comments and suggestions for 30 days, starting May 3, 2021 until June 2, 2021.

To request the document:

Comments received from stakeholders and interested parties will be reviewed after the 30 day comment period. All comments will be considered in finalization and adoption of the document.

Who is the focus of this consultation

This guide is for sterile manufacturers.

Contact us

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

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