Guidelines for Temperature Control of Drug Products during Storage and Transportation (GUIDE-0069)

This page in no longer valid and a new guidance document has replaced the old one
Letter of Introduction (Guide-0069)

(October 17, 2005)

Contact: 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, 2^nd Floor
250 Lanard Avenue
Address Locator # 2002B
OTTAWA, Ontario
K1A 0K9

October 17, 2005

05-122757-934

To: Associations / Stakeholders

I am pleased to inform you that the final version of the guidance document entitled "Guidelines for Temperature Control of Drug Products during Storage and Transportation" is now available on Health Canada's Compliance and Enforcement website at:

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

This document was developed following the survey conducted in 2003 by Health Canada (HPFB Inspectorate) regarding transport and storage conditions of drug products. The results of this survey indicated a need for additional guidance to ensure that the requirement of the Food and Drug Regulations pertaining to storage and transport of drug products are met.

A draft document was posted for comments on the Inspectorate website in December 2004. The comments received have been reviewed by the Drug Good Manufacturing Practices (GMP) Committee and those that were accepted have been included in this new document.

Inquiries about this guidance document can be sent to the Manager, Drug GMP Inspection Unit, HPFB Inspectorate, by telephone 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
Michelle Boudreau (for)

Jean Lambert
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

GUIDE-0069

Guidelines for Temperature Control of Drug Products during Storage and Transportation

Supersedes:
Draft for comments

Date issued:
October 17, 2005

Date of implementation:
November 17, 2005

Ce document est aussi disponible en français.

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