Drew Hope, PhD, BSc (Hons), MRSB, GMP compliance consultant and UK qualified person at eXmoor Pharma, looks at what manufacturers should expect from a contract QP.
If the first time a QP sees a problem is at the point of batch certification, then the issue has usually started much earlier. During my QP training, a lecturer explained to a class of eager delegates that a contract QP cannot expect, or be expected, to show up at a site solely to certify batches. Although the legal batch certification duties of a QP are the key deliverable in a contract, their wider responsibilities as a custodian of GMP at a manufacturing site are frequently more demanding. In my sector, where Cell and Gene Therapy (CGT) manufacturing is complex, sterile and often aseptic, I know that the QP’s effectiveness depends on how well they understand the wider operation. In this article we will consider how contract QPs avoid those first-sight-at-certification problems, and what contract-giving manufacturers should expect from a QP.