GMP Compliance

Good Manufacturing Practices (GMPs) are Standard policies and procedures designed to ensure product quality and effective risk management.

In Canada, production, importing, packaging, labeling, distribution and storage of regulated products must be compliant with Good Manufacturing Practices (GMP).

MCS Associates conduct on-site qualified audits recognized by Health Canada to ensure that all steps in your manufacturing and operating practices meet the strict GMP requirements.

GMP Requirements

  • Compliance Audits
  • Customized Training Programs (Computer based and In-class)
  • Design and manage Canadian QA/QC systems
  • Compliance issue resolution
  • Write Standard Operating Procedures (SOP)
  • Validations
    • a)Computer Validations
    • b)Cleaning Validation
    • c)Process Validation
    • d) Analytical Methods Validation
    • e) Analytical Methods Validation
    • f) Equipment Qualification
    • g) Utility Qualification
  • Interactions with Health Canada inspectors
  • Due Diligence Audits

MCS Associates can help you meet all requirements set by Health Canada.

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GMP Activities:
  • Specifications and Test Methods
  • Raw Material and Final Product Testing
  • Stability Study Design and Execution
  • QA Quality Assurance Reviews
  • QC Quality Control
  • Utility Qualification
  • Procurement
  • Sample Retention
  • Adverse Reaction Reporting Program
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