Annex to the Good Manufacturing Practices Guidelines Good Manufacturing Practices (GMP) for Positron Emitting Radiopharmaceuticals (PERs) (GUI-0071)

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

February 15, 2006

Unit name: Drug GMP Inspection Unit
Telephone: 613-952-9319
Fax: 613-957-6709
E-Mail: GMP_Questions_BPF@hc-sc.gc.ca

Cover Letter

Health Products and Food Branch
Inspectorate
Graham Spry Building, 2^nd Floor
250 Lanark Avenue
Address Locator # 2002B
Ottawa, Ontario
K1A 0K9

February 15, 2006

06-101671-686

To: Associations

The final version of the Positron Emitting Radiopharmaceuticals (PER) Annex to the Good Manufacturing Practices (GMP) Guidelines is now available on the Health Products and Food Branch Inspectorate website of Health Canada:

These guidelines were developed in consultation with a working group of external experts, with the objective of enhancing Health Canada's ability to ensure the high quality, safety, and efficacy of PERs used in Canada, and to provide further clarification to manufacturers on the regulatory requirements for the production of these drugs. The draft version of this document was posted on Health Canada's website for comment in January 2005, and comments and suggestions received during the public consultation period were considered in the finalization of this document.

Inquiries about this document can be addressed to the Drug GMP Inspection Unit by telephone at (613) 952-9319, by fax at (613) 957-6709, or by e-mail at GMP_Questions_BPF@hc-sc.gc.ca.

Original signed by
Diana Dowthwaite
Director, Compliance & Enforcement Coordination Division

Cover Page

Our Mandate

To promote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the Canadian marketplace and health system.

Health Products and Food Branch Inspectorate

Annex to the Good Manufacturing Practices Guidelines

Guide-0071

Supersedes:
New document

Date Issued
February 15, 2006

Date of implementation:
March 30, 2006