For any organisation that plays a role in the supply of pharmaceutical products such as manufacturing, QC testing, packaging, storage and distribution, an audit is an essential exercise to evaluate the level of compliance to the required GxP standards. All personnel operating or supporting the manufacturing of medicines are required to understand the current Good Manufacturing Practice (GMP) requirements as detailed in Eudralex Vol 4 and the other applicable standards such as ICH, PIC/S, EMA, gxp which ensure that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use.

Why are QP audits necessary?

QP Audits are necessary to verify the GMP quality standards of all sites involved in the supply of medicines. It is not sufficient to rely on documented evidence alone from companies that they are following appropriate procedures. An experienced auditor can gain a much deeper insight into the GMP compliance level of a site compared to reviewing documentation/ meetings with that site.

So, what is a QP Audit in this context?

From a regulatory perspective Annex 16 (EudraLex Volume IV) states in point 1.7.3 that the QP must ensure that all audits of sites involved in the manufacture and testing of medicinal products and in the manufacture of the active substance have been carried out and that the audit reports are available to the releasing QP.

The Qualified Person is responsible for certifying batches for release to a clinical trial or onto the market. The QP is the gatekeeper of all Quality aspects impacting the product. As a result, it is expected that the QP will be involved in the conduct of audits of parties in the supply chain that have the potential to impact directly on the quality of IMPs or marketed products. A risk-based approach is ideal, whereby the QP will be one auditor of the audit team that performs the audits on critical third parties.

In larger companies, a global audit group may own the audit schedule. This can limit the ability of the QP to be part of the audit team. In this scenario, it is expected that the QP will be able to input into the audit agenda to ensure that topics of direct relevance and/or concern to them will be reviewed during the audit.

The QP needs to be involved in considering the outcome of the audit – the level of compliance of the site and to gain insight into any GMDP deficiencies or gaps identified.

The QP needs to be kept informed of the status of CAPAs to ensure that they can take due account of action programs at the site in the context of continuing to disposition batches of IMPs or marketed products.

QP Audits can be outsourced, to be performed by appropriately experienced and competent third parties. The QP needs to have confidence in the auditor’s ability to conduct the audit as needed. As a result, the QP should be part of the process for selecting and qualifying auditors. This can be as simple as a review of the CV of the auditor. It can also be achieved as part of the process to prepare for the audit, where discussions are held to define the audit agenda.

How MIAS Pharma can help?

MIAS Pharma is a QP batch certification site. We partner with our clients to provide quality oversight of the supply chain supporting our batch certification activities. This includes the conduct of third-party audits and working with you, our clients, to resolve supply chain challenges that have the potential to impact the market supply of your medicines.

For more information read our QP Audit services.  Get in touch with us here:


What is involved in the preparation of an Audit