Building a pharmaceutical facility during drug approval stage can put companies in an extremely risky and costly position. Before you pour your concrete or sign your lease your best insurance policy is an independent GMP review of your facility design.
Why waste money on remediating your facility after it has been built in order to meet GMP compliance? You could save yourself a substantial amount of money if your GMP review is completed in advance.
A GMP facility review will ensure your facility is designed and constructed to meet the requirements of GMP and the expectations of the Regulatory Agencies during the Pre-Approval Inspection.
Our experienced team of consultants can help you with the design, design review, selection and installation of facilities and equipment. We provide the following services to support GMP facility design and build and Biotech facility design and build:
- Advice and support in the design and construction of the new GMP or Biotech facility or the re-design and fit out of an old facility
- Review of facility plans and drawings to meet GMP requirements
- Map the GMP facility design and build process and incorporate phases for
- Development of design and construction phases
- Development of URS for utilities and equipment
- Facility construction and finish
- Installation, commissioning and qualification of facility and equipment
- Guidance and support on the preparation of documentation for GMP compliance including drawings to be submitted to the regulatory agency (or to be available to the agency), FAT and SAT protocols and reports, Commissioning protocols and report, IOQ protocols and reports
McGee Pharma International, a Pharmalex company, has a vast team of consultants including a number of former EU regulators, who have the appropriate technical experience and expertise to provide services supporting GMP facility design and build and Biotech facility design and build. We’ve seen what works and what definitely doesn’t.
Remember the remediation costs can far exceed the cost of using an independent consultant to perform a GMP review of your facility from the outset.