Cannabis Quality Assurance (GACP/GMP)

  • Development of quality assurance documentation (Standard Operating Procedures, forms, batch records, logs)

  • Training of staff in quality assurance practices and procedures

  • Development of sanitation program

  • Assistance in the implementation of manufacturing/enterprise resource planning (ERP) software and document control software

  • Audit preparation

  • Quality assurance support (monthly/yearly terms)

Quality Assurance

  • Compliance with World Health Organization (WHO) Good Agricultural and Collection Practice (GACP) and European Medicines Agency (EMEA) GACP

  • Gap analysis for compliance with WHO GACP and EMEA GACP requirements

  • Assistance in closing all gaps and development supporting documentation

  • Execution of GACP compliance audit (virtual/on-site)

  • Preparation of GACP compliance report

GACP Compliance

  • Compliance with Good Manufacturing Practices (GMP)

    • EU GMP (Europe)

    • TGA GMP (Australia)

  • Advisement on floorplan compliance to GMP requirements, personnel flow, and product flow

  • Preparation of documentation required for GMP compliance, including Validation Master Plan (VMP), Site Master File (SMF), Facility User Requirement Specification (URS) and Design Qualification (DQ), Cleaning Validation Protocol, Processing Validation Protocol, and Stability Program Protocol

  • Execution of GMP compliance audit (virtual/on-site)

GMP Compliance

  • Development of customized supplier qualification requirements for various supplier categories, including cultivators, processors, nurseries, raw material suppliers, and packaging suppliers

  • Execution of supplier qualification audit (virtual/on-site)

  • Management of corrective action plan

  • Oversight of corrective action plan implementation

  • Annual follow-up audits

Supplier Qualification