New guide to validation of terminal sterilization process of drugs

Drug Establishment Licensing Bulletin 171, November 12, 2024

On November 12, 2024, the Health Product Compliance Directorate posted the following guidance document:

• Guide to validation of terminal sterilization processes for drugs (GUI-0074)

This guidance replaces the following 3 documents:

• Process validation: Gaseous sterilization for pharmaceuticals (GUI-0007)
• Process validation: Irradiation sterilization for pharmaceuticals (GUI-0009)
• Process validation: Moist heat sterilization for pharmaceuticals (GUI-0010)

This guidance is for sterile drug fabricators who have to establish the scientific effectiveness of terminal sterilization processes. It will help them comply with Part C, Division 2 of the Food and Drug Regulations, which is about good manufacturing practices (GMP).

The principles outlined in this guidance can also apply to the sterilization of:

• raw materials
• bulk materials
• in-process drugs
• packaging materials
• natural health products

Health Canada developed the guidelines in consultation with stakeholders.

The guidelines are written to align with International Organization for Standardization (ISO) standards.

Key topics covered by the guidance are:

• process design
• lifecycle approach
• ongoing process verification
• process performance qualification
• process validation for sterilization by moist heat
• process validation for sterilization by ethylene oxide
• process validation for sterilization by ionizing radiation

Natural health products

The principles described in GUI-0074 can be applied to natural health products. The Natural Health Products Regulations require that proper good manufacturing practices be followed to ensure that products meet the definition of a sterile product, which could include terminal sterilization.

Manufacturers, packagers, labellers and importers of sterile NHPs should follow the guidelines set out in the following guidance documents:

• Good manufacturing practices guidance document for natural health products
• Annex 1 to the Good manufacturing practice guide – Manufacture of sterile drugs (GUI-0119)

Contact us

If you have questions, you should contact the Health Product Inspection and Licensing Division of the Regulatory Operations and Enforcement Branch. Email us at drug.gmp.questions-bpf.medicaments@hc-sc.gc.ca.