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Manufacturing Practices Guidelines updated

August 11, 2009

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Health Canada has finalized Good Manufacturing Practices (BMP) Guidelines 2009 Edition. These guidelines come into effect Nov. 8, 2009. 

This updated document includes modified and/or new terminology, additional requirements and interpretations, and an updated table of requirements. Amendments to the Food and Drug Regulations will be incorporated in a subsequent version of this document.

Appendix A offers additional information regarding the changes to the 2009 edition of the document. New expectations for premises, equipment, personnel, sterile products, and quality control are outlined.

Appendix B offers information on future changes to the guidelines, which will become effective on March 1, 2010.

Originally published in the August 11, 2009, issue of The Link