![]() These guidelines interpret the requirements for good manufacturing practices (GMP) in Part C, Division 2 of the Regulations. The scope of this document does not include:Įstablishment licensing - To understand how to comply with GMP requirements to get an establishment licence, see Guidance on Drug Establishment Licences (GUI-0002).Īctive pharmaceutical ingredients - Guidelines for active pharmaceutical ingredients (APIs) are described in Health Canada's Good manufacturing practices for active pharmaceutical ingredients (GUI-0104). The following table shows the three types of icons used in this document, and the way they are intended to be used. Developing a pharmaceutical quality system.Checklist – GMP regulations by activity. ![]() This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the regulations and the applicable administrative policies. ![]() This document does not constitute part of the Food and Drugs Act (the Act) or its regulations and in the event of any inconsistency or conflict between the Act or regulations and this document, the Act or the regulations take precedence. ![]()
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