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.

Our services include:

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

Audits and Self Inspection

Quality Assurance inspections

 

GMP self-inspections to GMP standards

 

Support during government audits of contractors and suppliers
Q&R Canada, Canada Compliance, Product regulatory, Health Canada, sop charts

Documentation Management

Specification development

 

Creation and management of quality assurance documents

 

Document control systems

Product Releases

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).

Temperature Control/Mapping

Warehouse and storage (product and retains)

 

Temperature mapping & monitoring

 

Transportation procedures and documentation

 

Freeze/Thaw Studies

Standard Operating Procedures

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.

Stability Programs

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.

Other Quality Assurance Systems

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.

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