Validation Studies

MCS Associates can help navigate validation requirements for your products

Current validation documentation requirements exist for fabricators, packagers, labelers, testers, importers and distributors of regulated product. Inspectors will evaluate at the importer’s site evidence of validation studies related to cleaning validation studies, test method validation and process validation plans and/or data. Typically, compliance with these requirements is evaluated regionally during site inspections.

MCS designs and executes Master Validation Plans for process, cleaning and analytical test methodology

The required information depends on if the regulated product is manufactured, packaged, labeled and/or tested domestically; in countries having signed a Mutual Recognition Agreement (MRA) with Canada; or in non-MRA countries.

Distributors of Domestic Products

Regulated products fabricated, packaged, labeled and tested in Canada.

Distributors require a Certificate of Manufacture with a Certificate of Analysis or a fabricator’s batch certificate; a copy of the fabricator’s establishment license and complete process validation information, on an individual product basis.

Importers: MRA-Countries

Regulated products fabricated, packaged, labeled and tested in MRA-Countries.

Importers require a fabricator’s Batch Certificate and the importer’s Establishment License that identifies the qualified foreign site fabricator.

Importers: Non-MRA Countries

Regulated products fabricated, packaged, labeled and tested in non-MRA Countries.

Importers require a Certificate of Manufacture with a Certificate of Analysis; the importer’s Establishment License that identifies the qualified foreign site fabricator; product specific process validation; test method validation; and a certified copy of the approved conclusions of the product validation studies.




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Types of Validations
  • Computer Validations
  • Cleaning Validation
  • Process Validation
  • Analytical Methods Validation
  • Equipment Qualification
  • Utility Qualification
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