Updates to Health Canada’s GUI-0119: Manufacture of Sterile Drugs

Health Canada has issued an update to GUI-0119, Manufacture of sterile drugs. GUI-0119 is an annex (Annex 1) to the Good manufacturing practices guide for drug products (GUI-0001).

The updated GUI-0119 was made effective on April 1, 2024 and replaces the February 2018 version.

This guide helps to understand and comply with good manufacturing practices (GMP) for fabricating and packaging/labelling of sterile drugs.

With this new revision, Health Canada has adopted the updated recommendations for manufacturing sterile drugs published by PIC/S in September 2022. These updated recommendations are also being adopted by the EMA, WHO and various international partners within the PIC/S organization to harmonize global standards.

The key changes in the guidance include:

Reorganization of material into 11 distinct sections, which helps to eliminate ambiguities and inconsistencies within the guide:

1. Scope

2. Principle

3. Pharmaceutical Quality System (PQS)

4. Premises

5. Equipment

6. Utilities

7. Personnel

8. Production and specific technologies

9. Environmental and process monitoring

10. Quality control (QC)

11. Glossary

Expansion of Scope to include additional areas beyond sterile products such as contamination control strategy, design of premises, cleanroom classification, qualification, validation, monitoring and gowning of personnel.

Description of Contamination control strategy (CCS) – the CCS defines critical control points and assesses the effectiveness of all controls (design, procedural, technical and organizational) and monitoring measures used to manage risks to drug quality and safety.

Incorporation of Quality Risk Management (QRM) approach. QRM ensures that microbial, particulate and endotoxin/pyrogen contamination is prevented in the final product.

Introduction of Restricted Access Barrier Systems (RABS) as a barrier technology to protect the product from potential extraneous sources of endotoxin/pyrogen, particulate and microbial contamination and quickly detect potential contaminants in the environment and the product.

Highlight elements of the Pharmaceutical quality system (PQS) which help ensure that all activities are effectively controlled, to minimize the risk of microbial, particulate and endotoxin/pyrogen contamination in sterile drugs.

Clearly outline Cleanrooms and its grades in the Premises section. A requirement for the need to be able to observe and supervise production activities from outside the grade A and B areas has been added.

Elaborate on Equipment section and identify the need for a cleaning and sterilization process of the equipment, if applicable.

The implementation of the new concept, Contamination Control Strategy, requires a multidisciplinary approach, and therefore is by far the most important and challenging concept for the Quality Assurance department to understand and implement in the manufacturing of sterile products as the minimum expectations are not yet clear.

If you would like to learn more about these updates or how to ensure compliance, please contact Regxia today at info@regxia.com or via phone at 416-620-5236.  Our team of Regulatory and Quality experts are ready to assist you in reaching your goals.