Guidance on Parametric Release - Pharmaceutical Inspection
Co-Operation Scheme (PIC/S)
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
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
Ce document est aussi disponible en français.
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