Pharmacy

The Simbec Pharmacy is fully GMP and GCP compliant.

Inspections and Accreditations:

• Manufacturer’s/Importer’s Authorisation for Investigational Medicinal Products (MIA(IMP) No 4757)
• MHRA GMP Inspections 2004, 2006, 2008 & 2011
• GMP Certificate (Aug 2008)

We have the capability to work with many different and novel formulations, including preparation of placebo for blinding compliance. We manufacture IMP onsite and release direct to clinic (including short shelf life products).

Our pharmacy is responsible for:

• Blinded and dose escalation studies
• Microdosing studies
• Primary and Secondary packaging (e.g. tablets, capsules, inhalers etc)
• Blinded Randomisation code generation
• Annex 13 Compliant IMP Label design
• Manufacture or procurement of NIMPs (e.g. challenge agents)
• Importation of IMP from Third Countries
• Quality Control Release Testing (via Contract Laboratory)

Our highly trained staff includes four Qualified Persons who offer covers:

• Expertise in formulation/CMC advice
• Regulatory advice e.g. IMPD preparation
• Audit of Third Country Sites, GMP Declarations and Certification of IMP upon importation

Our state-of-the-art pharmacy facilities include:

• Grade A Type I Positive Pressure Isolator and HLF cabinet for sterile production
• Grade C Production Area
• GCP/GMP compliant segregated material storage
• Controlled ambient temperature in Production and Storage areas
• Controlled Refrigerated (2 to 8ºC) and Frozen (-15 to -25ºC) storage
• Continuous temperature monitoring & alarm system

Simbec is fully compliant with all Controlled Drugs requirements, with a full range of Home Office licenses and suitable storage/record keeping.