Validation documentation requirements exist for fabricators, packagers, labelers, testers, importers and distributors of regulated products. They must validate their systems or risk audit findings and possibly the loss of an Establishment Licence or FDA approval.

Inspectors will evaluate at the importer’s site evidence of validation studies related to cleaning validation studies, test method validation, process validation plans and/or data and evidence of meeting labelled storage conditions (mapping and validation).

Q&R Canada Inc. can help navigate validation requirements for your products including:

  • Write a Validation Master Plan
  • Develop and execute Protocols
  • Write the final reports.

Analytical Method


Cleaning Validation

Processing Equipment (Removal of product residues, degradation products, preservatives, excipients and/or cleaning agents)


Equipment Validation

(IQ, OQ, PQ)

Temperature Mapping

Storage Areas, Cooler, Freezers, Incubators (Stability Chambers), Shipping Containers

Transportation Vehicles

Carriers, Shipping Routes

Process Validation

Manufacturing process (prospective, concurrent or retrospective)

Facility Validation

(utilities, HVAC, water)

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.