Quality

Some of the hyperlinks provided are to sites of organizations or other entities that are not subject to the Official Languages Act. The material found there is therefore in the language(s) used by the sites in question.

Should you have any questions or comments regarding the content of the guidance documents found on this page please contact:
Health Canada – ICH Coordinator
Email: hc.ich.sc@canada.ca

Q1: Stability testing

Q2: Analytical Validation

Q3: Impurities

Q4: Pharmacopoeias

Q5: Quality of Biotechnological Products

Q6: Specifications

Q7: Good Manufacturing Practice

Q8: Pharmaceutical Development

Q9: Quality Risk Management

Q10: Pharmaceutical Quality System

Q11: Development and Manufacture of Drug Substances

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