SERVICES →

GMP Programs and Quality Support

SERVICES →

GMP Programs and Quality Support

For over 20 years, small, medium and multi-national organizations have called upon us to provide GMP audit and quality support for their regulated activities, to lead or improve quality control/assurance initiatives or to provide remediation guidance.

Our comprehensive services helps to improve your operational control, reduce costs, mitigate risks and comply with diverse regulatory demands.

Services and Solutions

Production

  • Material Qualification
  • Method/Process Validation
  • Cleaning Validation
  • Computer System Validation
  • Facility Qualification

Documentation Services

  • Technical Writing
  • Standard Operating Procedures (SOPs)
  • Stability Program Design & Management
  • Quality Manuals & Policies
  • Finished Product Specifications
  • Work Instructions
  • Quality Agreements

Importation and Distribution Support

  • Importer QMS Program
  • Release / Reject Program
  • Importer Quality Assurance Person (QAP)
  • Distributor QMS Programs

Post Market Services

  • Post-Market QMS Programs
  • Recall Management
  • Ongoing Stability
  • Self Inspections
  • Vendor Qualifications

Audits and Remediation

A comprehensive GMP audit can identify GMP compliance and quality issues well before they become problems.  We provide a thorough evaluation of manufacturing operations, documentation processes, complaints handling and record keeping and provide recommendations for improvement.

  • Health Canada Inspection and NHP Inspection Program* (Virtual and Onsite Hosting & Support)
  • Health Canada NHP Inspection Program
  • The GMP Gap Analysis
  • Third Party Onsite Audits (Foreign & Domestic)
  • QAR
  • Remediation Plans

*Health Canada site license inspection pilot program

Training

  • Good Manufacturing Practices (GMP) – Basics & Applied
  • Deviation, OOS Investigation and CAPA
  • Change Control
  • Pharmaceutical Process and Cleaning Validation
  • Stability (Shelf-life, On-Going, Accelerated and Freeze-Thaw)
  • Complaint Handling

Contact Us