MedPharm plans expansion of its GMP manufacturing capabilities

MedPharm is investing in a new, purpose-built GMP manufacturing facility to be located close to its R&D headquarters. It is planned for operations by end of Q1 2011. The new facility will enable MedPharm to continue to offer full formulation development capability right through to manufacture of GMP supplies for Phase 1 or Phase II clinical trials.

Check back with us for progress and updates.

GMP Manufacturing

Since the implementation of the Clinical Trial Directive 2001/20/EC in May 2004, it is a requirement that all clinical trial supplies are manufactured to GMP standards.

To offer further integrated services to our clients, MedPharm has extended the activities of the R&D Centre to provide additional services in the development chain in the form of GMP clinical trial supply manufacture.

MedPharm has now the ability to progress formulations developed through to phase I/II clinical trials.

The following activities will be undertaken:

  • Transfer analytical methods,
  • Source raw materials,
  • Manufacture of batches to GMP standards of topical dosage forms for ICH stability trials and clinical evaluation for Phase I/II trials,
  • Sterile Manufacture
  • Process validation,
  • Cleaning validation,
  • Test batches to provisional specifications,
  • Small-scale manufacturing,
  • Powder manufacture by spray-drying, micronisation,
  • MDI development activities,
  • Special projects: there are a large number of companies with unusual projects where they may need particular assembly of drug delivery systems. In most cases people and facilities are required and possibly special designed assembly equipment.
  • Industrial scale-up.

 

Please download our brochure for a complete range of services:

GMP Facility (PDF)