Contact Name: Drugs GMP Inspection Unit
Tel: (613) 957-1492
Fax: (613) 952-9805
E-Mail: GMP_Questions_BPF@hc-sc.gc.ca

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Cover Letter

Health Products and Food Branch Inspectorate
2nd Floor, 11 Holland Avenue
Holland Cross, Tower A
Address Locator #3002C
OTTAWA, Ontario
K1A 0K9

October 15, 2001

01-113030-842

To: Associations

Re: Guidance on Parametric Release - Pharmaceutical Inspection
Co-Operation Scheme (PIC/S)

The above mentioned document was adopted, after consultation with industry, at the PIC/S meeting of officials held in May 2001. Canadian stakeholders were consulted in June 2000 when Draft 7 of this document was published. As a member of PIC/S, the Health Products and Food Branch Inspectorate (HPFBI) may adopt and implement PIC/S guidance documents.

The PIC/S document 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 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 as it is still a regulatory requirement in Canada to perform full testing of a drug in its final dosage form against its specifications before it is released for sale.

Since no other Canadian guidance documents is available and this one is in accordance with the Canadian Regulations for sterility testing exemption (C.01.065), the Inspectorate recommends that it be used when Process Parametric Release Authorization are requested. Please note that requests will be considered only for terminally sterilized drugs in their immediate containers and following submission and approval of evidence acceptable according to this guidance.

This document became effective on September 1st, 2001 for member countries of PIC/S. It can be found on the Inspectorate website at
www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate. A french version of this document, translated by the Inspectorate, is also available. Inquiries about this document can be addressed to Ms. France Dansereau, Head of the Inspection Unit, National Coordination Centre, Health Products and Food Branch Inspectorate by e-mail at GMP_Questions_BPF@hc-sc.gc.ca or by fax at (613) 952-9805.

Yours sincerely,
Original signed by
Danièle Dionne (for)

Jean Lambert
Director General

Cover Page

PHARMACEUTICAL INSPECTION CONVENTION
PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME

PI 005-1
3 August 2001

RECOMMENDATION
on the

ARCHIVED - Guidance on parametric release

© PIC/S August 2001
Reproduction prohibited for commercial purposes.
Reproduction for internal use is authorized,
provided that the source is acknowledged.

Editor:
PIC/S Secretariat
9 - 11 rue de Varembé
CH-1211 Geneva 20
Tel. + 41 22 749 13 24
Fax + 41 22 740 14 37
E-mail: pics@efta.int
Web site: http://www.picscheme.org

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