Process Validation: Aseptic Processes for Pharmaceuticals

(April 1, 2003)

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
Holland Cross, Tower "A"
2^nd Floor, 11 Holland Avenue

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Address Locator # 3002C
OTTAWA, Ontario
K1A 0K9

April 11, 2003

03-100069-318

TO: ASSOCIATIONS

I am pleased to inform you that a revised version of Guide 0006 entitled "Process validation: Aseptic Processes for Pharmaceuticals" is now available on the Health Products and Food Branch Inspectorate website at the following address:

http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate

This document has been revised to harmonize its content with version 2 of the Good Manufacturing Practices (GMP) Guidelines, 2002 Edition. No major changes to the requirements were made, therefore, consultation is not deemed necessary.

Inquiries about this document can be addressed to Ms. France Dansereau, Manager, Inspection Unit, at the National Coordination Centre, by telephone at (613) 957-1492, by fax at (613) 952-9805 or by e-mail at GMP_Questions_BPF@hc-sc.gc.ca.

Original signed by
Danièle Dionne (for)

Jean Lambert
Director General

Cover Page

Health Products and Food Branch Inspectorate

GUIDE

Process Validation:
Aseptic Processes for Pharmaceuticals

Supersedes
May 1, 2001

Date issued:
April 1st, 2003

Date of implementation:
June 1st, 2003

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