ARCHIVED - PIC/S Annex 17 : Parametric release

Unit Name: Drug GMP Inspection Unit
Telephone: 613-957-1492
Fax: 613-957-6709

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Cover Letter

Health Products and Food Branch Inspectorate
Graham Spry Building, 3rd Floor
250 Lanark Avenue
Address Locator # 2003D
OTTAWA, Ontario
K1A 0K9

January 4, 2008



I am pleased to inform you that Health Canada has adopted the revised PIC/S guidance document entitled "Guide to Good Manufacturing Practice for Medicinal Products Annex 17, Parametric Release", which is now available on Health Canada's Compliance and Enforcement website.

This guideline, which replaces the previous 2001 version, addresses both the elimination of the sterility testing and other finished product testing based on parametric release. At this time, the Food and Drug Regulations (C.01.065 (b) (ii)) only allows for the elimination of the sterility testing based on parametric release. Therefore, the part of this document addressing the elimination of the other finished product testing will not be considered, since full testing of a drug in its final dosage form, against its specifications and prior to it being released for sale, remains a Canadian regulatory requirement.

This guidance document should be used when seeking authorization to eliminate the sterility testing based on parametric release. Please note that the elimination of the sterility testing will only be considered for terminally sterilized drugs in their immediate containers and following the submission and approval of acceptable evidence as per this guideline.

As a member of PIC/S, the Health Products and Food Branch Inspectorate (HPFBI) may adopt and implement PIC/S guidance documents. This is done in order to work towards the global harmonization of technical standards and procedures related to Good Manufacturing Practices (GMP). This document does not constitute part of the Food and Drugs Act (Act) or the Food and Drugs Regulations (Regulations) and in the event of any inconsistency or conflict between that Act or Regulations and this document, the Act or the Regulations take precedence. 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 is not intended to provide legal advice regarding the interpretation of the Act or Regulations. If a regulated party has questions about their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel.

Inquiries about this guidance document can be submitted in writing by mail to the Manager, Drug GMP Inspection Unit, HPFB Inspectorate, Graham Spry Building, A.L. #2002B, 250 Lanark Avenue, Ottawa, Ontario, K1A 0K9, by telephone at 613- 957-1492, by fax at 613-957-6709, or by
e-mail at .

Original signed by

Diana Dowthwaite
Director General

Cover Page



PE 009-6 (Annexes)
5 April 2007

Guide to good manufacturing practice for medicinal products annexes

©PIC/S April 2007
Reproduction for commercial purposes.
Reproduction for internal use authorized, provided that the source is acknowledged.

Secrétariat PIC/S
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