Project Management

Source life science consulting offers GMP project management services to help you get up and running and comply with the relevant regulations. Our extensive experience in the pharmaceutical, biological, biotech and medical device industries will ensure that critical compliance issues are on the project plan. Underestimating the required validation effort is another common project management mistake.

Our team is made up of a wide range of industry experts who provide our clients with practical advice and solutions that are tailored specifically to your organization's requirements, internal resources and capabilities in the commissioning and qualification (C&Q) of process equipment, utility systems, and facilities.We understand the complexities of working with your organization and the inter-departmental interactions of Construction Teams, as well as those of Operations, Facilities, Engineering, and Quality.

Our team has extensive experience in building teams for on-site and off-site assignments designed to lead and support compliance and validation initiatives. Whether we are assisting a client by helping them augment their existing team through staffing services or building a highly qualified team to support an outsourcing effort, our focus is on bringing the right level of talent to bear on your projects.

Our documents are designed and laid out to promote the efficient generation of qualification protocols such as IQ, OQ and PQ. However, its not just the documents but the hands on practical in the trenches experience which is invaluable and access to colleagues with this professional knowledge.

Whether it is an existing facility, or a brand new facility manufacturing pharmaceuticals, medical devices or biologics; our consultant can navigate their way through the regulations and help you set up a compliant and practical validation approach and you can have confidence.

  • Source life science consulting LLC 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,material flows, people flows, equipment flows,prevention of cross contamination,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 including identifying appropriate GMP and Regulatory 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, 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.