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Manufacturing Practices Guidelines updated

August 11, 2009

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