Confidence Beyond Compliance

Validation activities required by EU GMP and FDA process validation guides include

  • Commissioning and Qualification of equipment, facilities, utilities and supporting services
  • Validation of cleaning methods
  • Validation of analytical Methods
  • Validation of the manufacturing process
  • Validation of warehousing and storage facilities (temperature mapping studies)
  • Validation of controls on environmental conditions during transportation of pharmaceutical products (temperature mapping studies of transportation routes)

PharmaLex’s team of experts, which includes a number of former EU regulators, have the appropriate experience and technical expertise to provide services supporting your organisation’s commissioning, qualification and validation activities in compliance with GMP and FDA process validation guides, including:

  • Mapping the GMP facility commissioning, qualification and validation process, including workstreams for
  • development of URSs for facilities, equipment and utilities
  • facility, equipment and utilities installation, commissioning and qualification
  • cleaning and analytical method validation
  • manufacturing process validation including
  • appropriate GMP and Regulatory stage gates
  • Quality, engineering, validation, technical, procurement, supply chain, manufacturing, IT and regulatory roles
  • specifying handover documents and information from one phase to the next.
  • Providing expert technical guidance and support on the preparation of validation documentation in compliance with GMP and regulatory agency inspector expectations, including
    • Validation Policies
    • The Validation Master Plan
    • Validation procedures
    • Validation protocols
    • Validation reports
    • Reports and the associated records of actions taken or conclusions reached as part of validation activities
  • Providing expert technical guidance on achieving outputs meeting GMP compliance and regulatory agency inspector expectations for all validation activities
  • Management of and inputs to validation projects to ensure:
    • key milestones of the project are identified
    • challenges to the commissioning and qualification or validation process are identified
    • application of Quality Risk Management to the process, in accordance with ICH Q9
    • input from the Quality perspective from the beginning through to the end of the process
    • commissioning and qualification or validation activities are completed effectively, efficiently and meet regulatory expectations and compliance
  • Assisting your organisation in compiling validation documentation and records for the Pre-Approval Inspection