Confidence Beyond Compliance

The design, construction, commissioning and qualification of a new GMP facility is typically managed over a number of project phases. The objective of the project is to design and construct a facility which meet the requirements of GMP and the expectations of the Regulatory Agencies during the Pre-approval Inspection (PAI).

Typically, project phases start with development of Design and Construction Specifications for the facility with concomitant development of User Requirement Specifications (URSs) for the utilities and equipment. The project then progresses to construction of the facility and installation, commissioning and qualification of the facility and its supporting utilities.

Essential to the success of the GMP facility design and build is the clear assignment of roles and responsibilities to all functions involved, whether outsourced or in-house, a commitment to compliance with GEP (Good Engineering Practice) and GMP and oversight by Quality to ensure appropriate quality systems are implemented at appropriate points in the process and that stage gates are met in terms of the quality of the documentation generated to support progression to the next phase.

PharmaLex provides the following services to support GMP facility design and build and Biotech facility design and build activities.

  • Advice and support in the design and construction of the new GMP or Biotech facility
  • Review of facility plans and drawings for compliance with GMP in terms of
    • material flows, people flows, equipment flows
    • prevention of cross contamination
    • environmental conditions
    • systems for control of critical parameters that impact product quality
    • supporting utilities while interpreting GMP regulations and guidance to suit the product type
  • Mapping the GMP facility design and build process, incorporating phases for
    • development of design and construction specifications
    • development of URSs for utilities and equipment
    • facility construction and finish
    • facility and equipment installation, commissioning and qualifications and
      • including identifying appropriate GMP and Regulator stage gates
      • incorporating engineering, validation, technical, procurement, supply chain, manufacturing, IT, quality and Regulatory Affairs roles
      • specifying handover documents and information from one phase to the next.
    • Support in the management of GMP and Biotech facility design and build projects, whether for a new facility or for the re-design and fit out of an existing facility, to ensure that
      • key milestones of the project are identified and met
      • challenges to the success of the project are identified
      • GMP compliance risks are identified and actions to mitigate the risks are identified and implemented
      • there is appropriate Quality management oversight of the process
      • the design and build process is completed effectively, efficiently and meets regulatory expectations and compliance
    • Guidance and support on preparation of documentation required for GMP compliance, including:
      • Drawings to be submitted to the Regulatory Agency or to be available to the Regulatory Agency, to obtain approval for the new facility
      • User Requirements Specifications
      • FAT and SAT protocols and reports
      • Commissioning protocols and reports
      • Equipment installation and operational qualification protocols and reports
      • Utilities installation and operational qualification protocols and reports
      • SOPs for equipment and utilities calibration, maintenance, cleaning and use
      • Change Control, Deviation Investigation and CAPA SOPs required for GMP compliance and implemented during appropriate phases of the project.

PharmaLex’s team of experts, which includes a number of former EU regulators, have the appropriate technical experience and expertise to provide services supporting GMP facility design and build and Biotech facility design and build projects.