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These guidelines interpret the requirements for good manufacturing practices (GMP) in Part C, Division 2 of the Regulations. They were developed by Health Canada in consultation with stakeholders.
Good manufacturing practices (GMP) ensure drugs meet the appropriate quality standards for their intended use before they are sold. To ensure compliance with GMP regulations, Health Canada inspects establishments that fabricate, package/label, test, distribute, import or wholesale drugs.
Health Canada, issuing body. Title : Good manufacturing practices for active pharmaceutical ingredients. Variant title : Good manufacturing practices for active pharmaceutical ingredients, version 2 (GUI-0104) Publication type : Monograph : Language [English] Other language editions :
"Replaces: Good manufacturing practices guide for drug products (GUI-0001) (February 28, 2018)." Includes bibliographical references (pages 152-159). Information sur la publication [Ottawa] : Health Canada = Santé Canada, 2020. ©2020 : Description : 1 online resource (159 pages) ISBN : 9780660347059 : Numéro de catalogue : H139-15/2020E-PDF
These guidelines interpret the requirements for good manufacturing practices (GMP) in Part C, Division 2 of the Regulations. Guidance documents like this one are meant to help industry and health care professionals understand how to comply with regulations.
This guideline on Good Manufacturing Practices (GMP) pertain to Division 2, Part C of the Food and Drug Regulations. The guidelines apply to pharmaceutical, radiopharmaceutical, biological, and veterinary drugs and were developed by Health Canada in consultation with stakeholders.
These guidelines interpret the requirements for good manufacturing practices (GMP) in Part C, Division 2 of the Regulations. They were developed by Health Canada in consultation with stakeholders.
