Batch testing, Qualified Person review and QP certification are critical elements of the EU batch release process.
Conscio provides fully GMP-compliant batch release testing and QP certification services, helping pharmaceutical companies meet applicable regulatory and Marketing Authorisation requirements efficiently and on time.
The specific testing and certification requirements for medicinal products depend on the product, its manufacturing and supply chain, the applicable Marketing Authorisation and the country of origin.
Medicinal products imported into the EU or EEA from countries not covered by an applicable Mutual Recognition Agreement generally require batch retesting before market release. For products imported from countries covered by an applicable MRA or equivalent arrangement with the EU, certain retesting requirements may be waived, subject to the scope of the agreement and the availability of the required GMP and batch documentation.
For medicinal products for human use, the EU batch release process is governed primarily by Directive 2001/83/EC and the relevant requirements of the EU GMP Guide. Annex 16 defines the principles of Qualified Person certification and batch release, while Annex 21 sets out GMP requirements for medicinal products imported from outside the EU and EEA.
Capabilities:
We support a wide range of dosage forms, including solids, liquids, injectables, oral films (ODFs), patches, and more.
For a more detailed overview of EU batch release testing and QP certification requirements, read our dedicated White paper here.
Our R&D teams assess, verify and, where necessary, optimise analytical methods before routine cGMP testing begins. This helps reduce the risk of out-of-specification (OOS) results, method-related investigations and costly project delays.
Method suitability is evaluated using a systematic, risk-based approach. Depending on the method and its intended purpose, the assessment may include relevant analytical performance characteristics such as specificity, accuracy, precision, linearity, range, detection and quantitation limits, and robustness, in line with applicable ICH guidance and regulatory expectations.
This thorough preparation helps ensure that analytical methods perform reliably during routine GMP testing while supporting product quality, data integrity and regulatory compliance.
Let’s talk. Whether you’re scaling operations or prepping for your next audit, we’ll help you take the next confident step.
