Qualified Person and medicinal product batch release – who authorizes a product for the market

A finished batch of a medicinal product, packed and labeled, is still not merchandise. Before it leaves the manufacturer’s warehouse, it must be formally released for the market – and this decision is made by one specifically named individual. Not the management board, not the sales department, and not the brand owner.

That individual is the Qualified Person, commonly referred to in industry practice as the Qualified Person (QP). Their signature closes the manufacturing process and changes the product’s status from work in progress to a medicinal product available to the patient. For a brand owner using an outsourcing model, understanding this role is of purely practical importance: the actual date on which the goods can be invoiced depends on it. Below, we explain how this mechanism works in a facility carrying out contract manufacturing of medicinal products.

Who the Qualified Person is and where their role comes from

The obligation to employ a Qualified Person arises directly from EU law – Articles 48–52 of Directive 2001/83/EC impose it on every holder of a manufacturing authorization. In the Polish legal system, this role is governed by Article 48 of the Pharmaceutical Law Act, which defines both the scope of responsibilities and the required qualifications.

The Qualified Person is not an administrative position, but a function based on personal responsibility. Their position rests on three pillars:

• formal qualifications – field-specific education covering the required range of subjects and documented experience in the qualitative and quantitative analysis of medicinal products;
• decision-making independence – refusal to release a batch cannot be overturned by a superior’s instruction or by a decision of the facility owner;
• continuous availability – the manufacturer must ensure that the function is covered throughout the entire period of operation, including by a deputy.

The Qualified Person’s details are already indicated in the application for a manufacturing authorization for medicinal products. Failure to fill this function is grounds for refusing to issue the authorization – and the loss of this function during operations effectively stops batch release.

What batch release for the market involves

Batch release is confirmation that a specific batch has been manufactured and controlled in accordance with the regulations and with the documentation approved in the marketing authorization. The Qualified Person does not assess the product “by eye” or solely on the basis of an analytical result – they review the entire history of the batch.

This assessment includes production records, certificates of analysis for raw materials and packaging materials, results of in-process controls and finished product testing, equipment qualification status, and the course of all deviations recorded during manufacturing. An unresolved deviation blocks release, even if the product parameters are within specification.

The assessment ends with an entry in the batch certification register. It is important to understand that this is a binary decision – there is no such thing as “conditional release” or “release pending clarification.” The batch is either authorized for the market or remains in quarantine until all open quality issues have been closed.

A separate regime applies to products imported from outside the European Economic Area. In the case of import, each batch is subject to full qualitative and quantitative analysis at least with regard to the active substances, performed within the territory of the EU. A manufacturer’s certificate from a third country is not sufficient in itself – except in cases covered by mutual recognition agreements.

Batch release in the contract manufacturing model

In a contract arrangement, the Qualified Person operates on the manufacturer’s side, not the brand owner’s side. As the marketing authorization holder, you do not release the batch and cannot force this decision – however, you are responsible for the product on the market, which is why you need full transparency in this process.

The tool that ensures this transparency is the technical agreement (Quality Agreement), agreed before the start of cooperation with a contract manufacturer. It should clearly describe who provides the input data for batch assessment, by what deadline the manufacturer provides the documentation, how deviations are reported, and what the procedure looks like for a batch on hold.

Batch release does not, in fact, end the manufacturer’s obligations. Requirements relating to packaging safety features, described in more detail in the article on serialization of medicinal products, are fulfilled at the same stage. Serialization data must be submitted to the system before the product enters distribution.

What the QP’s role means for your schedule and budget

The most common mistake in launch planning is treating the production completion date as the date when the goods become available. Between one and the other lie the completion of batch documentation, the results of release testing, and the Qualified Person’s review. The better prepared the process, the shorter this interval.

The quality of process preparation before the first commercial batch has the greatest impact on the speed of batch release. Properly conducted manufacturing process validation reduces the number of deviations, and a stable raw material specification reduces the number of out-of-range results. We describe the principles on which this repeatability is based in the text on Good Manufacturing Practice principles.

The practical conclusion for the brand owner is therefore as follows: when choosing a partner, ask not only about production capacity, but also about the average batch release time and the method of deviation reporting. These two parameters determine the predictability of supply.

Choose a manufacturer with a stable batch release process

A predictable batch release date comes from a mature quality system, not from goodwill. Laboratorium Galenowe Olsztyn, part of the Eubioco group, operates on the basis of a GMP certificate valid until 2028 and its own quality control facilities, which enables batch control to be carried out without waiting for external laboratories. Do you want to plan the production of a medicinal product with a realistic schedule for product availability? Contact us at sprzedaz@eubioco.eu to discuss your project and receive a quotation.

BIBLIOGRAPHY

1. Act of 6 September 2001, Pharmaceutical Law (Journal of Laws of 2001, No. 126, item 1381, as amended), Article 48.
2. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Official Journal of the EU L 311 of 28.11.2001, p. 67), Articles 48–52.
3. Regulation of the Minister of Health of 9 November 2015 on the requirements of Good Manufacturing Practice (Journal of Laws of 2022, item 1273, as amended).
4. European Commission (2022). EudraLex – Volume 4: Good Manufacturing Practice (GMP) guidelines, Annex 16: Certification by a Qualified Person and Batch Release. [online] Available at: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en [accessed online: 12.08.2026]
5. Chief Pharmaceutical Inspectorate (2026). Issuance of an authorization to manufacture or import a medicinal product. [online] Available at: https://www.gov.pl/web/gif/wydanie-zezwolenia-na-wytwarzanie-lub-import-produktu-leczniczego [accessed online: 12.08.2026]