GMP Documentation Review and Approval

A DSA Quality Consultant helps ensure that your company holds all the information required under Canadian Good Manufacturing Practices (GMPs). Documentation compliance is a major component of today’s Health Canada inspections and you need to ensure that your firm is prepared to meet the requirements.

Our GMP Consultants will review your master production documents and your batch documentation to ensure compliance with GMP. Our team of GMP Specialists offers valuable expertise for review and approval of batch deviations, reprocessing and rework. We ensure your documentation is comprehensive enough to meet Health Canada expectations.

Let our GMP Consultants review your cleaning, process and equipment validation protocols to ensure compliance with Canadian GMPs and/or ICH guidelines. We then review your validation data and/or data summaries to ensure compliance with your protocol. Our GMP Consultants can provide valuable assistance in ensuring your protocols are satisfactory in meeting Canadian requirements, before you undertake your studies. We can assist you in preparing data summaries and conclusions and if needed, approve your final reports.

We review your stability protocols to ensure your compliance with Canadian GMPs and/or ICH guidelines and/or marketing authorization. We then review your stability data to ensure compliance with your protocol. Our Consultants can provide valuable assistance with investigation of OOS (out-of-specification) and OOT (out-of-trend) results.

Contact us today to ensure you are meeting your documentation responsibilities under Canadian GMP and find out more about our GMP Consulting Services.