Documentation Review

There is a lot of information that companies are required to hold in order to meet Health Canada expectations under the Canadian Good Manufacturing Practices (GMPs/NHP GMP).

Our team at Q&R Canada Inc. offers valuable experience and expertise in the review and approval of all GMP documentation including:

  • Master production documents
  • Batch documentation (including batch deviations, reprocessing)
  • Cleaning validation protocols and reports
  • Process validation protocols and reports
  • Equipment validation protocols and reports
  • Method Validation protocols and reports
  • Stability Protocols and data

We will review your protocols to ensure compliance with Canadian GMPs and/or ICH guidelines and/or marketing authorization. We then review your report to ensure compliance with your protocol.

Rely on Q&R Canada as your trusted partner for Canadian Regulatory Compliance. Working with you as your regulatory partner, we can and will provide exceptional, personalized and expert service as an integral component in building and protecting your company’s brand and profits.