Batch certification by the QualQualified Person (QP) is the formal quality act by which an individual finished product batch is released for use. In doing so, the QP confirms that manufacture and testing of the batch comply with the applicable GMP requirements and the specifications applicable to the product. For investigational medicinal products, the suitability of the batch for the clinical trial is assessed prior to release on the basis of the relevant documentation.
Decision on the individual finished product batch
What is certified is not a manufacturing site, not product development, and not the clinical trial as a whole, but a specific finished product batch. Annex 16 describes certification as the part of the batch release process that constitutes the quality release of the batch. Only after this decision can transfer into saleable stock or export take place; for investigational medicinal products, it complements the other study-specific release steps.
The Qualified Person is responsible for ensuring that each batch has been manufactured and tested in accordance with the legal requirements applicable at the place of certification and complies with GMP. For investigational medicinal products, they must also take into account the specific requirements of the clinical trial, knowledge of pharmaceutical development, and the supply chain of the specific batch. Certification is therefore not merely a signature after completion of quality control.
The qualified-person entry relates to the person’s role and qualification. Batch certification, by contrast, describes their action with a specific batch. This distinction is essential: a qualified person does not achieve certification of a batch simply by being appointed; only their documented decision after reviewing the required information has this legal and quality relevance.
Scope of review and documented basis
Before certification, the assessment is based, among other things, on batch documentation, control and in-process test reports, deviations, additional tests performed, manufacturing conditions, and the qualification of equipment as well as the validation status of processes and methods. For investigational medicinal products, the documentation should also demonstrate compliance with the Product Specification File, order, trial protocol and, where applicable, the randomisation code.
The Product Specification File must be accessible to the Qualified Person because it forms the basis for assessing the suitability of the specific batch. Also relevant are stability data, origin and evidence of suitable storage and shipping conditions, and the involvement of manufacturing, packaging, labelling and testing sites. The depth of review cannot be replaced by a generic checklist, because product origin, development phase and supply chain must be taken into account.
Certification is recorded in a register or an equivalent document. This makes it clear which Qualified Person assessed which batch. For subsequent investigations of quality defects or recalls, this allocation and the underlying records are decisive.
Distinction from official batch release by authorities
Batch certification by the Qualified Person is not identical to official batch release by authorities. Annex 16 explicitly excludes “Official Control Authority Batch Release” for certain blood and immunological products from its scope. However, the Annex does address certification by the Qualified Person and the subsequent release of such batches.
Official batch release by authorities is therefore not simply another name for QP certification. It is based on a specific official control for certain product groups. A batch may therefore, in a given case, be subject both to QP certification as the manufacturer’s quality act and to a separate official procedure. For investigational medicinal products, this distinction must not be blurred by the regulatory release of trial shipments.
Relevance for clinical trials
For clinical trials, batch certification consolidates the product-related review before a batch enters the supply chain. Incomplete documentation on packaging, testing, deviations or transport can delay the decision, even though the trial is already advanced from a regulatory perspective. For imported investigational medicinal products or those handled at multiple sites, it also becomes apparent whether all quality information is actually available to the Qualified Person.
Full-service CROs such as Mediconomics provide support by coordinating batch status lists with study demand, tracking approved labelling documentation, and aligning sponsor, manufacturer, depot and trial sites. This work does not replace the Qualified Person’s decision, but it ensures that study information relevant to certification is available in an organised manner and that subsequent supply is aligned with it.
Certification must also not be derived solely from planning data. It is performed on the basis of the batch records actually generated and the results, deviations and actions reviewed in relation to them. This is why it is positioned at the end of the quality-relevant manufacturing and control chain.
Frequently Asked Questions (FAQ)
What does batch certification relate to for an investigational medicinal product?
It relates to the specific finished product batch. The Qualified Person reviews its GMP compliance and the requirements relevant to its use in the clinical trial.
Is the Qualified Person comparable to the QPPV?
No. The Qualified Person is responsible for batch certification in the GMP context. The QPPV is a pharmacovigilance function with different tasks.
Is a passed quality control sufficient for certification?
No. Analytical results are important, but the assessment also covers manufacturing documentation, deviations, equipment and process status, the supply chain, and other relevant documentation.
Regulatory References
- EU GMP Guide, Annex 16, Section 1.1 – requires certification of every finished product batch by a Qualified Person prior to release.
- Detailed Commission Guidelines C(2017) 8179 final, Section 8 – specifies the certification of investigational medicinal products prior to use in a trial.
- Regulation (EU) No 536/2014, Article 62 – sets out the certification requirement for investigational medicinal products.