Batch release testing and Qualified Person (QP) certification are mandatory steps for placing medicinal products on the EU market. Conscio provides a fully GMP-compliant service that ensures your products meet all regulatory requirements efficiently and on time.
Medicinal products imported from non-MRA (Mutual Recognition Agreement) countries must undergo batch re-testing and QP certification before market release. Manufacturers from MRA countries may qualify for exemptions, but full GMP documentation is required. These requirements follow EU GMP Annexes 16 and 21 and Directive 2001/83/EC.
Batch release testing and Qualified Person (QP) certification are mandatory steps for placing medicinal products on the EU market. Conscio provides a fully GMP-compliant service that ensures your products meet all regulatory requirements efficiently and on time.
Medicinal products imported from non-MRA (Mutual Recognition Agreement) countries must undergo batch re-testing and QP certification before market release. Manufacturers from MRA countries may qualify for exemptions, but full GMP documentation is required. These requirements follow EU GMP Annexes 16 and 21 and Directive 2001/83/EC.
With GMP-certified laboratories in Czechia, Slovakia, and Austria, strategically located in the heart of Europe, we offer:
Capabilities:
We support a wide range of dosage forms, including solids, liquids, injectables, oral films (ODFs), patches, and more.
Our R&D teams verify and optimise methods before cGMP testing begins, reducing the risk of Out-of-Specification (OOS) results and preventing costly delays. To enhance method suitability, robustness is assessed early using a systematic approach—this includes evaluating parameters such as specificity, accuracy, precision, linearity, detection limits, and robustness, in line with ICH and FDA expectations. Such thorough preparation ensures that analytical methods perform reliably during routine GMP testing and helps safeguard product quality 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.
