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Drugs and Health Products

Questions and Answers

Enquiries may be submitted by industry as questions directed to Operational Centres during an inspection, to Inspectorate Ottawa or through trade associations. In most instances the responses to such enquiries will have already been established and will have been addressed in the main Good Manufacturing Practices (GMP) Guideline or its Annexes, or through the compilation of existing GMP questions and answers (Q&As), based on previous responses to industry and trade associations.

However, when an exceptional situation arises, and for which there is no established interpretation already available in writing, the response to the situation may warrant it's inclusion in this list of Q&As. Alternate approaches to the situations described in these Q&As may be acceptable provided they are supported by adequate scientific justification.

Enquiries may be submitted by stakeholders or associations either by writing to the regional Operational Centres of the Inspectorate or to Inspectorate Ottawa. The enquiries should be sent to the respective Managers of the Drug GMP Inspection Unit of the Operational Centre or the Manager of the Drug GMP Inspection Unit within Inspectorate Ottawa. The addresses of the Operational Centres and Inspectorate Ottawa are available on Health Canada's Web site. Enquiries may be submitted by mail (regular or electronic) or by Fax.

Additional Reference