Quality Control/Quality Assurance

Q&R Canada Inc. provides a wide range of QC/QA services to our clients. We can provide services to set up your quality control department as your full-time Head of Quality Control or assist your quality personnel with implementation and/or maintenance of a compliant quality system.

For QC/QA advice, or complete design and management of your QA systems, Q&R can help.

  • Handling communication and correspondence with Canada’s Health Products and Food Branch Inspectorate (HPFBI)
  • Audits and Self Inspection
  • Documentation Management (Review and Approval)
  • Evaluating GMP compliance of suppliers and subcontractors
  • Coordinating product testing
  • Dispositioning product (product releases)
  • Mapping and Validation
  • Drug establishment licencing support
  • Medical device establishment licencing support
  • Recalls and complaint management
  • SOP implementation
  • Stability Programs
  • GMP Training
  • Site Reference Files
  • Annual Product reviews
  • Quality Assurance inspections
  • GMP self-inspections to GMP standards
  • Support during government audits of contractors and suppliers
  • Specification development
  • Creation and management of quality assurance documents
  • Document control systems
  • Review of lot/batch documents to ensure compliance with the master production document/label.
  • Arrange for confirmatory analytical testing (where applicable).
  • Release products for sale in Canada (if all documents are compliant).
  • Warehouse and storage (product and retains)
  • Temperature mapping & monitoring
  • Transportation procedures and documentation
  • Freeze/Thaw Studies

Development and training of Standard Operating Procedures (SOPs) and related documents and/or review of existing SOPs to ensure that they are current and meet regulatory requirements.

  • Set up accelerated, intermediate and/or room temperature studies.
  • Draft or review protocols for compliance with Canadian GMPs and/or ICH guidelines.
  • Implement and manage stability programs
  • Review and trend your stability data.
  • Complaint handling
  • Returned goods handling
  • Validation
  • Recalls

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.