GMP Clinical Manufacture & GLP Facilities
MedPharm has both GLP and GMP compliant laboratories at its base in the Surrey Research Park, just south of London.
MedPharm’s success has helped it to grow organically and it has invested profits in equipping and expanding these facilities. A new GMP facility, opened in 2013, sits adjacent to the company’s R&D labs and offices. This facility includes ISO 14644-1 compliant clean rooms (ISO 7 standard EU GMP Class C). The company is able to provide a complete service for clinical trial supplies, including manufacturing of batches up to 50 Kg, as well as labelling and randomisation services. The cGMP facility is designed for scale up and process design validation for semi-solids, aerosols and solutions. MedPharm offers services in
- Transfer of analytical methods
- Analytical and microbiological testing
- Sourcing of raw materials
- Manufacture of batches to cGMP standards of topical dosage forms for ICH stability trials and clinical evaluation for Phase I/II trials
- Process validation
- Cleaning validation
- Test batches to provisional specifications
- Small-scale manufacturing
- Industrial scale-up
MedPharm’s GLP compliant labs offer dedicated microbiology, API storage, microscopy and analytical and performance testing areas. They are equipped to a high standard with up-to-date scientific systems of ample capacity to allow multiple large studies to occur simultaneously. MedPharm is a member of the UK GLP Compliance Monitoring Programme and is assessed by the MHRA’s GLP Monitoring Authority and conforms to SI 3106, as amended by SI 994, 2004.
The laboratories have facilities and authorisation to handle OEB4 compounds.