Process Validation: Irradiation Sterilization for Pharmaceuticals

(March 1^st, 2001)

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 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

Guidance Document

Process Validation:
Irradiation Sterilization for Pharmaceuticals

Supersedes

Date issued:
March 1^st, 2001

Date of implementation:
May 1^st, 2001

*Revisions were made to this document on 2002-03-19 to reflect changes to the Health Products and Food Branch organizational structure. There were no other changes made to the content of the document.

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