Process Validation: Form - Fill - Seal for Drugs
(GUIDE-0008)

(June 30th, 2006)

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
Graham Spry Building, 2nd Floor
250 Lanark Avenue
Address Locator # 2002B
OTTAWA, Ontario
K1A 0K9

July 31, 2006

06-111448-505

To: Associations and Stakeholders

I am pleased to inform you that Health Canada has finalized the guidance document entitled "Process Validation: Form-Fill-Seal for Drugs", which is now available on Health Canada's Compliance and Enforcement website at:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/index-eng.php

This document has been reviewed as part of the Inspectorate's quality management process and has been amended to further clarify issues brought to the attention of the Inspectorate. Please note that no changes to the requirements were made, therefore, consultation is not deemed necessary.

Inquiries about this guidance document can be submitted in writing by mail to the Manager, Drug GMP Inspection Unit, by phone at (613) 957-1492, by fax at (613) 957-6709, or by e-mail at GMP_questions_BPF@hc-sc.gc.ca.

Original signed by

Diana Dowthwaite
Director General

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

Process Validation:
Form-Fill-Seal for Drugs

GUIDE-0008

Supersedes:
March 1st, 2001

Date issued:
June 30th, 2006

Date of implementation:
September 1^st, 2006

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