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Quality Assurance Consulting Services

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  • 3rd Party Audit services as well as subsequent gap analyses (in Canada and Out-of-Country For Good Manufacturing Practice (GMP) inspections to ensure that relevant Health Canada requirements are met for all types of pharmaceutical products such as active pharmaceutical ingredients (APIs), over-the-counter (OTC) drug products, excipients, and natural health products (NHPs).
  • Development and Implementation of GMP Compliant Quality Systems

    • Prepare and maintain Standard Operating Procedures (SOPs)
    • Host compliance (GMP) inspections by FDA and Health Canada
    • Product release as Quality Control
    • Manage finished product release and stability testing
    • Prepare and maintain product technical dossiers
  • Ongoing Quality Control and Quality Assurance Services
  • Prepare Technical Quality and Pharmacovigilance Agreements
  • Prepare and maintain Standard Operating Procedures (SOPs) for importers, distributors and wholesalers including GAP analysis for firms with existing SOPs.
  • Host or assist with Regulatory (Compliance) Health Canada Inspections (DEL, MDEL, GMP, GVP, API) from Start to Close-out
  • Host or assist with other Inspections/Audits from Start to Close-out

    • Third Party (Supplier)
    • Internal (Self-Inspections)
  • Preparation of Finished Product Specifications to comply with Health Canada requirements and handle future method validation and testing of product based on the specifications
  • Design and implement Stability Studies program

    • to establish shelf life of the product
    • for continuing stability program for existing and new drugs
    • for thermal cycling studies to support temperature excursions from labelled storage conditions
  • Deviation and CAPA management
  • Master Production Documentation review, approval and maintenance including process validations, method validations, batch production records, etc.
  • Generate Annual Product Quality Reviews (APQR) and/or review of APQR for accuracy and evaluate subsequent CAPA requirement
  • Customized Training Services

    • For a new startup to train personnel (including technical, maintenance, cleaning, warehouse, production line and quality staff)
    • For continuing annual GMP training program
  • Managing Product Recalls including Health Hazard Evaluation and recall classification
  • Complaint Handling and Management
  • Pharmacovigilance and Post-Market Surveillance

    • Establish and implement procedures to receive and analyze Adverse Event (AE)
    • Submit and maintain Adverse Drug Reaction (ADR), Adverse Reaction (AR) and Incident reports records
    • ADR/AR evaluation for seriousness and reportability
    • Facilitate filing of ADR and Incident reports to Canada Vigilance Program
    • Prepare annual summary reports (ASRs) and issue-related summary reports
    • Conduct literature scans, signal detection, identification of trends
    • Prepare, host or provide support for Health Canada Good Pharmacovigilance Practices (GVP) Inspections
  • Site Reference File
  • Temperature mapping and validation of

    • Shipping Containers
    • Transportation Vehicles
    • Storage Areas
  • Transportation Validation Studies of shipping routes for supply chain of regulated products
  • Qualification of

    • Coolers (IQ/OQ/PQ)
    • Freezers (IQ/OQ/PQ)
    • Incubators (IQ/OQ/PQ)
    • Clean rooms (ISO 7 and ISO 8)