Resources
Guides, analysis and lessons learned.
What our team has learned over more than 300 projects, to read, watch or use.
Resources
Tool
Our aseptic manufacturing audit checklist: 78 checkpoints
Video
Our services for hospitals and CSSSs
Video
No room for error
Article
PBE Expert, your GMP compliance partner
Interview
Waste and zero carbon: an interview
Publication
ICH Q9 risk management applied to pharmaceutical plants
FormAction™
Our GMP FormAction™ courses, recognized by the CPMT
FormAction™
CIPE FormAction™: from design to validation
Partnership
Partnership in Riyadh, in the presence of Canada’s ambassador
Regulatory resources
Official guidance to keep close at hand.
The references our experts consult every day, straight from the regulators’ websites.
Health Canada
- Good manufacturing practices guide for drug products (GUI-0001)The Canadian guidelines
- Annex 1 to the Good manufacturing practices guide – Manufacture of sterile drugs (GUI-0119)Cleanrooms, aseptic processes, contamination control
- Risk classification of good manufacturing practices (GMP) observations (GUI-0023)How inspectors classify observations
- Drug Establishment LicencesApplications and requirements (DEL)
- Natural health productsProduct and site licenses (NPN)
- Recalls and safety alertsThe Government of Canada database
U.S. FDA
(in English)
- 21 CFR Part 211: cGMP for finished pharmaceuticalsThe U.S. regulation
- 21 CFR Part 11: electronic records and signaturesThe foundation of computerized system validation
- Process Validation: General Principles and Practices (2011)The FDA guidance
- Sterile Drug Products Produced by Aseptic ProcessingThe FDA guidance
- FDA inspection guidesWhat inspectors look at
- FDA warning lettersReal-world findings, updated every week
Europe and international
(in English)
Let’s talk about your project.
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