GMP EU For Cro Phase 2 Audit Checklist

At a GMP audit, regulatory agency inspectors will carefully scrutinize documents, interview personnel and inspect production batches. An efficient audit management software such as SimplerQMS makes this task faster and simpler by quickly and effortlessly reviewing all documents, records and systems associated with pharmaceutical company documents, records and systems.

Documentation

The QP Declaration is a requirement in CT applications submitted for IMPs that were manufactured outside the EU, to certify their compliance with GMP standards at least equivalent to those anticipated within Europe. This two-part article serves as an essential foundation for U.S. sponsors in terms of creating clear responsibilities and expectations between themselves and EU QPs for an expeditious batch release process.

The QP Declaration must contain information from all companies involved with IMP manufacturing, conversion from API to finished drug product (including packaging and labelling) as well as laboratories responsible for stability testing. EU GMP compliance can be verified either via an audit of manufacturing site(s), or for biological or advanced therapy investigational medicinal products, by inspection by competent authority(s).

Processes

For GMP compliance, all manufacturing steps should be overseen by trained scientists, including upstream and downstream process development, formulation, and stability testing. A strong technical team composed of scientific, engineering, and pharmaceutical specialists should be established; this is particularly essential when dealing with products at early clinical trial stages that have yet to reach industrial maturity. This requirement applies especially when working on phage therapy products which remain industrially immature.

MHRA must be informed of any special GMP considerations in the production process, such as manufacturing tablets for use in producing inhaled penicillin (and other beta-lactams). Therefore, clear expectations with EU QPs must be set in order to prevent delays in batch release.

MHRA requires proof that EU GMP standards are at least equivalent to your local standards through a verification visit, including onsite inspections or third-party audits, with personal inspections or third party audits as appropriate. Furthermore, analysis by non-EU laboratories is acceptable.

Equipment

For GMP compliance, facilities must possess all of the necessary equipment. Furthermore, it must be regularly inspected to ensure it’s operating efficiently – an essential requirement of any pharmaceutical manufacturer. A GMP audit checklist will allow companies to keep an inventory of all equipment used at their facilities as well as document the results of inspection.

Be ready for an inspection when it begins and be sure you can provide all documents and records requested by the inspectors. Ideally, designating one person to remain with them and take notes during their inspection – this is especially helpful for CROs audited by MHRA. Furthermore, having a notebook ready is highly advised so as to fill it in during their visit.

Records

An audit checklist can be an excellent way to organize your thoughts for an on-site inspection, but remember it does not replace knowledge of GMP regulations. Furthermore, using a notebook for recording comments and questions during an audit is key; just be sure to label it with its type and date!

Both 21 CFR Part 11 and EU Annex 11 address electronic records and signatures; the difference lies in that 21 CFR Part 11 is a regulation with legal standing while EU Annex 11 offers guidance for implementation and management of computerized systems.

This two-part article has provided U.S. sponsors with an introduction to Quality Protocol (QPs), their terminology and how they work in support of clinical trials in Europe. Furthermore, valuable insights were offered regarding requirements that go beyond audit checklists such as drug substance considerations or handling shipping excursions during limited stability periods.