QP contract for CMO – Cell-based IMPs

A small sterile production facility in the North West of England required the services of an IMP QP to support the certification of an aseptically produced cell-based biological product. The organisation already employed a contract IMP QP who was known to JWQC. A direct recommendation lead the company to select our expertise to fulfil their additional QP needs.

JWQC’s specific experience in biological sterile product manufacture matched the customer’s needs and a tailored service to meet their specific requirements was provided. The JWQC QP:-

• worked flexibly with the customer to support timely release of this short shelf life IMP

• provided ad hoc advice to the small manufacturing and QC teams, promoting GMP awareness

• supported self-inspection and GMP investigations when required

Since working for this organisation JWQC QPs have been requested to provide ad hoc services to the academic institution that has taken over the use of this clean room facility.