Consultation: Draft Guidance on Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (APIs) Guidelines (GUI-0104)

Background

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.

Information on the Document

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:

• GUI-0104 interpretations are based on the ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients guideline and the current Good Manufacturing Practices (GMP) Guidelines - 2009 Edition, Version 2 (GUI-0001).
• Annex F of GUI-0104 provides a cross-walk between ICH Q7, GUI-0001 and GUI-0104 interpretations.

How to Get Involved and Deadline

The consultation period is open for comments and suggestions for 75 days, starting October 22nd, 2012 until January 5th, 2013.

• To request the document: Interested stakeholders who wish to provide comments may send a request for an electronic copy or alternate format of the document to GMP_questions_BPF@hc-sc.gc.ca.
• Please include in the subject line, the title and the preferred language of the consultation document you wish to receive.
• Comments received from stakeholders and interested parties will be reviewed after the 75 day comment period.

Reporting to Canadians

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.

Yours truly,

Diana Dowthwaite
Director General