The online consultation is now closed. The content found on this page is a snapshot of the live consultation as it was presented to the public and contains the content that was open for submissions during the consultation period. The new guide will be posted when the documents are finalized.
On September 29, 2012, proposed regulatory requirements amending the Food and Drug Regulations to extend Good Manufacturing Practices requirements to active ingredients (AIs), together with the Regulatory Impact Analysis Statement (RIAS) for the proposal, have been pre-published for public consultation in the Canada Gazette, Part I. The present draft document Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (APIs) Guidelines (GUI-0104) provides interpretive guidance for the manufacture of APIs as per the proposed regulatory amendment.
GUI-0104 was designed to facilitate compliance by the regulated industry and to enhance consistency in the application of the regulatory requirements. As well, it is intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.
The document being consulted on - Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (APIs) Guidelines (GUI-0104) - is part of the overall process to bring the proposed amended Food and Drug Regulations into force. Highlights of this document are as follows:
The consultation period is open for comments and suggestions for 75 days, starting October 22nd, 2012 until January 5th, 2013.
Health Canada will make the results of this consultation available on this Web site. Any questions or comments should be addressed to GMP_questions_BPF@hc-sc.gc.ca.