Good Manufacturing Practices

Guidelines,2002 Edition, Version 2

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Introduction

These guidelines on Good Manufacturing Practices (GMP) refer to Division 2, Part C of the Food and Drug Regulations. The guidelines apply to pharmaceutical, radiopharmaceutical, biological, and veterinary drugs and were developed by Health Canada in consultation with their stakeholders. These guidelines are designed to facilitate compliance by the regulated industry and to enhance consistency in the application of the regulatory requirements.

Division 1A, Part C of the Food and Drug Regulations defines activities for which GMP compliance is to be demonstrated prior to the issuance of an establishment licence. In addition to these guidelines, further guidance in specific areas is provided in the annexes to this document or in separate documents.

The content of this document should not be regarded as the only interpretation of the GMP Regulations, nor does it intend to cover every conceivable case. Alternative means of complying with these Regulations can be considered with the appropriate scientific justification. Different approaches may be called for as new technologies emerge.

The guidance given in this document has been written with a view to harmonization with GMP standards from other countries and with those of the World Health Organization (WHO), the Pharmaceutical Inspection Cooperation/Scheme (PIC/S) and the International Conference on Harmonization (ICH).

The present edition of this document reflects the results of regulatory revisions due to the implementation of the Mutual Recognition Agreements (MRA) Framework. The MRA establishes mutual recognition of GMP compliance certification and assessment methods by regulatory authorities of countries designated as equivalent.

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