White Paper: Canadian Guidelines for GMP Of API
Published April 2021
Abstract:
Good Manufacturing Practices (GMP) is defined as "a system for ensuring that products are consistently produced and controlled according to quality standards." In Canada, GMP for active pharmaceutical ingredients (API) is governed by the Food and Drug Regulations. GMP for APIs addresses all areas that affect process performance and product quality, including premises, equipment, personnel sanitation, raw material testing, manufacturing control, quality control, packaging material testing, finished product testing, records, samples, and stability.
This white paper covers:
- GMP for API
- Annex to GMP for Sterile API
- GMP for Sterile Manufacturing
- ICH, Non-compliance, and CTD
Keywords: API, manufacturing, Health Canada, dosage form, WHO, thalidomide pandemic, FDA, quality control, sanitation program, contamination prevention, raw material testing, sterile API, clean room, sterile manufacturing, ICH, CTD
Click here to view White paper: Canadian Guidelines for GMP Of API