Good Manufacturing Practices

MCS Associates conduct on-site audits recognized by Health Canada to ensure that all steps in your manufacturing and operating practices, meet current Good Manufacturing Practices (GMP).

MCS Associates Inc. consultants work with your company to design a GMP program for each facility. MCS can also develop corresponding training programs for your staff to ensure that the program is properly implemented.

New Canadian regulations came into effect January 1, 2004 for Natural Health Products. The NHP Directorate stipulates that product license holders are responsible for ensuring that Good Manufacturing Practices (GMP) are followed throughout the production and distribution chain.

Those needing to meet the provisions of the Good Manufacturing Practices are:

  • Foreign Manufacturers
  • Domestic Manufacturers
  • Packagers
  • Labelers
  • Distributors
  • Importers
  • Warehousing/Storage Facilities

A Site License is required for each site where manufacturing, packaging, labeling or importing activities of Natural Health Products takes place. Distributors in Canada must follow Good Manufacturing Practices, but do not require a Site License.

MCS Associate Services include GMP Protocols and Procedures, SOP Writing, Site Auditing, preparation of the Quality Assurance Summary Report, On-site Training and Educational support for your personnel to ensure that a valid Site License is maintained.

Manufacturers, importers, distributors/storage, packagers and labelers are required to comply with new regulations. MCS provides consulting services for assessing and meeting these requirements based on the specific needs for each business or operation.

Contact us about any Site License issues

In Canada, production, importing, packaging, labeling, distribution and storage of NHP Products must be compliant with Good Manufacturing Practices.

MCS Associates consult for many companies to develop, implement, and monitor the SOP process. MCS Associates also provides full support training to all of your employees.

GMP address Quality Assurance, Accredited Personnel, Operations , Sanitation and Cleaning programs, Equipment & Premises, Product Specifications, Samples, Stability, Records, Recall Reporting, and Sterile Products.

MCS experts conduct on-site audits recognized by Health Canada to ensure that all steps in your manufacturing and operating practices, meet current Good Manufacturing Practices.

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GMP (Good Manufacturing Practices) are measures to ensure an effective comprehensive approach to product quality control and risk management.
  • Quality Assurance
  • Accredited Personnel
  • Standard Operating Procedures
  • Sanitation and Cleaning Program
  • Equipment and Premises
  • Product specifications
    • samples
    • stability
    • records
    • recall reporting
    • sterile products
GMP Compliance of foreign-site fabricators;
  • Report from National Health Authorities
  • Health Canada
  • Third Party Audit Report
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