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GMP Standard Operating Procedures

The Canadian GMP Interpretative Guidelines define a Standard Operating Procedure (SOP) as a written procedure giving instructions for performing operations not necessarily specific to a given product or material but of a more general nature. SOPs are used to describe all facets of drug manufacturing to drug distribution and post-marketing compliance.

We have stock SOP templates that have evolved over more than 20 years of dealings with Health Canada and managing compliance issues on behalf of our clients. Our SOPs have been subject to numerous audits by Health Canada Inspectors and have been written to meet the highest level of auditor scrutiny. DSA specializes in preparing SOPs that are succinct, effective and easy to follow. We offer a wide range of SOPs and Protocols to cover a full range of GMP compliance topics.

For clients with existing SOPs, DSA can work with your team to review your SOPs against regulatory requirements and prepare a gap analysis to outline any shortcomings.

"Thank you for helping us with our Master Validation Plan. We had no idea where to start or what Health Canada wanted to see. We only wish that we had found DSA before we drafted our own SOP manual. You would have saved us from many comments on our inspection report."

-Dorothy, Quality Manager
DSA Client