C.02.017Finished Product Testing C.02.018 C.02.019Records C.02.020 C.02.021 C.02.022 C.02.023 C.02.024Samples C.02.025 C.02.026Stability C.02.027 C.02.028Sterile Products C.02.029Medical Gases C.02.030
Annex A Internationally Harmonized Requirements for BatchCertificationAnnex B Application for Alternate Sample RetentionAnnex C ReferencesGMP Committee members
These guidelines on Good Manufacturing Practices (GMP) refer toDivision 2, Part C of the Food and Drug Regulations. The guidelinesapply to pharmaceutical, radiopharmaceutical, biological, andveterinary drugs and were developed by Health Canada inconsultation with their stakeholders. These guidelines are designed tofacilitate compliance by the regulated industry and to enhanceconsistency in the application of the regulatory requirements.Division 1A, Part C of the Food and Drug Regulations definesactivities for which GMP compliance is to be demonstrated prior tothe issuance of an establishment licence. In addition to theseguidelines, further guidance in specific areas is provided in theannexes to this document or in separate documents.