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
Aseptically designed Pharmacy Assembly Suite GMP Grade C (ISO Class 7) equipped with a negative pressure Isolator GMP Grade A (ISO CLASS 5)
Staff
1 full time Pharmacist and 2 full time 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 technique
Complex primary and secondary packing procedures
Capsule filling
Over encapsulation
Non-sterile liquid manufacture and dispensing
Importation
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
Reconstitution/dilution of IMP that is required to be given in a syringe/bag and labelled prior to immediate administration (Post QP certification labelling)
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
