Pharmacy

Facilities

  • Dedicated area for pharmacy procedures with access restricted to trained personnel
  • Segregated storage areas
  • Capable of IMP storage at ambient (15-25°C), refrigerated (2-8°C) or frozen (-20°C) with 24/7 back up
  • Grade D Production Area
  • Safety cabinet

Staff

  • 2 full time GPhC registered Pharmacy Technicians with more than 40 years combined experience in management of clinical trials
  • 2 contract QPs
  • Trained, dedicated support staff

Experience In

  • Various IRT methods
  • Aseptic manipulation
  • Complex primary packing procedures
  • Capsule filling
  • Over encapsulation
  • Liquid manufacture and dispensing

Capabilities

  • Robust procedures in place to ensure accurate traceability and accountability of IMP and NIMP
  • Procedures in place to produce unblinding envelopes for third parties or use in house
  • Destruction of IMP using an approved vendor

Activities undertaken in pharmacy facility:

  • Primary packing of tablets and capsules (oral or inhalation)
  • Secondary packing (Post QP certification labelling)
  • Reconstitution/dilution of IMP that is required to be given in a syringe/bag and labelled prior to immediate administration
  • Batch certification of imported aseptically prepared sterile products, non-sterile products, and gene therapy products

Activities undertaken in clinical area for immediate administration by pharmacy/ clinical staff:

  • Preparation/Reconstitution/Dilution of IMP for subcutaneous, intradermal, intravenous, intramuscular injection or nebulisation
  • Dispensing of tablets/capsules from bulk stock
  • Dispensing of oral solutions from subject specific stock