Process Validation: Terminal Sterilization Processes for Pharmaceutical Products
GUIDE-0074

(November 17, 2006)

Unit Name: Drug GMP Inspection Unit
Telephone: (613) 957-1492
Fax: (613) 957-6709
E-Mail: GMP_Questions_BPF@hc-sc.gc.ca

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Cover Letter

Health Products and Food Branch Inspectorate
Graham Spry Building, 2^nd Floor
250 Lanark Avenue
Address Locator # 2002B
OTTAWA, Ontario
K1A 0K9

November 17, 2006

06-118148-342

To: ALL INTERESTED PARTIES

I am pleased to inform you that Health Canada has developed the guidance document entitled "Process Validation: Terminal Sterilization Processes for Pharmaceutical Products", which is now available for comments on Health Canada's Compliance and Enforcement website at:

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

This document replaces the previous version of "Process Validation: Gaseous Sterilization for Pharmaceuticals" (Guide-0007), "Process Validation: Irradiation Sterilization for Pharmaceuticals" (Guide-0009) and "Process Validation: Moist Heat Sterilization for Pharmaceuticals" (Guide-0010).

This document is published as a draft document for comments. Please note that every comment received within 75 days of delivery of this letter will be reviewed and considered for the final version of the document. Please submit your comments 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 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: Terminal Sterilization Processes for Pharmaceutical Products

GUIDE-0074

Supersedes:
GUI-0007, GUI-0009 and GUI-0010

Date issued:
Draft for comment

Date of implementation:
N/A

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