The Quality Assurance process starts at the very beginning of each project by incorporating quality by design into all experiments. In addition to this principle, the CBF also ensures that raw materials are suitable for use by releasing all consumables, reagents and cleaning products against a master Certificate of Analysis. Through a system of batch records and audits, all materials used in the production process are logged to ensure full traceability. Buffer components are each tested for proper identification, and where required, tested to pharmacopoeial standards to fulfill regulatory requirements.
Many of the standard in process tests and QC release tests are also carried out in house. These include:
endotoxin testing (LAL assays)
Batch record review is a multi-step process; each critical procedure is checked at the time of completion by a member of the production team. The entire batch record is then checked by the Production Manager, Quality Assurance Manager, and Head of CBF. The batch is released to trial by the on-site Qualified Person.
As required by the regulators, the CBF has a self-inspection schedule, complaints system and recall procedure.
The QA Manager ensures all relevant staff are trained to the appropriate standard with documentation to prove that training has occurred. Yearly GMP training is provided to all staff and any significant updates to Statutory Instruments, Annexes and Guidance Notes as published by EMEA/MHRA are disseminated to the staff to ensure that all work is carried out to the highest standard.