Good Manufacturing Practices
Guidelines,2002 Edition, Version 2
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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
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.