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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
- 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
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