Services · QP Batch Release · Roles we take on
Qualified Person (QP) services: interim QP, batch certification and imports
Anyone who manufactures, imports or releases medicinal products needs a Qualified Person under § 14 AMG. A&O certifies your batches under its own manufacturing and import authorisation (MIA), including investigational medicinal products and imports from third countries, or provides an interim or part-time QP at your site.
Key points at a glance
Reviewed by Dr. Olaf Mundszinger
Legal basis checked against the statutory text, as of October 2026
Anyone who manufactures or releases medicinal products, or imports them from third countries, needs at least one Qualified Person under § 14 AMG who can fulfil the duties at all times.
Before a batch is placed on the market, the Qualified Person certifies that it was manufactured and tested in line with the requirements (§ 19 AMG, Annex 16).
A&O certifies your batches under its own manufacturing and import authorisation, or provides an interim or part-time Qualified Person at your site.
On site
Production and quality control work independently of each other and each sign their own record. Only on this basis does the Qualified Person release the batch.
At A&O Pharma
A&O's Qualified Persons certify your batches under A&O's own manufacturing authorisation under § 13 AMG: authorised medicinal products under Annex 16, investigational medicinal products under Regulation (EU) No 536/2014. You do not need a Qualified Person of your own for this step. For authorised medicinal products, A&O must be named as the batch release site in the marketing authorisation.
A Qualified Person from A&O takes on the role on an interim or part-time basis at your site and is named in your manufacturing or import authorisation. This suits a vacancy, an absence, or a role that does not justify a full-time position. We agree the level of on-site presence so that the obligations can be fulfilled at all times, as § 14(1) AMG requires. Like any Qualified Person, they are integrated into your quality management system and operations.
A&O imports your medicinal products under its own import authorisation, retests the batches in its GMP-certified laboratory in Itzehoe (EU retesting) and certifies them. A&O oversees GMP-compliant manufacturing at the third-country manufacturer and qualifies manufacturers through audits. Testing, supply chain and certification stay with one provider.
Process
You describe the product, its origin, the authorisation status and what you need. A Qualified Person gets back to you within 1 to 2 days.
Together we decide whether A&O certifies your batches, an A&O QP works at your site or A&O imports the product. Responsibilities are set out in a written contract under Chapter 7 of the EU GMP Guide.
If A&O certifies, A&O must be named as the batch release site in the marketing authorisation. If an A&O QP is named in your authorisation, you notify the authority in advance (§ 20 AMG).
We review the documents, specifications and supply chain, then routine batch certification begins.
What the law requires
Anyone who manufactures medicinal products commercially or professionally needs a manufacturing authorisation under § 13 of the German Medicinal Products Act (AMG). Under § 4(14) AMG, manufacturing expressly includes batch release. § 72 AMG applies the same rule to imports from outside the EU and EEA. Under § 14(1) AMG, the authorisation is refused if there is not at least one Qualified Person or if that person cannot fulfil their obligations at all times. For investigational medicinal products, Article 61 of Regulation (EU) No 536/2014 requires the authorisation holder to have permanent and continuous access to a Qualified Person.
Under § 19 AMG, the Qualified Person ensures that every batch has been manufactured and tested in accordance with the legal requirements for medicinal products, and certifies this in a register or equivalent document before the batch is placed on the market. The release process is governed by § 16 of the German Ordinance on the Manufacture of Medicinal Products and Active Substances (AMWHV) and by EudraLex Volume 4, Annex 16. Under Annex 16 point 1.1, only a Qualified Person of a manufacturer or importer named in the marketing authorisation may certify. For investigational medicinal products, the Qualified Person certifies each batch under Article 62 of Regulation (EU) No 536/2014.
For medicinal products from third countries, the Qualified Person ensures that each batch has undergone, in a Member State, a full qualitative analysis and a quantitative analysis of at least all active substances (Article 51 of Directive 2001/83/EC, § 17 AMWHV). This requirement can only be waived where the EU has an agreement with the exporting country. Annex 16 also requires:
a documented supply chain of the active substance and medicinal product up to certification (point 1.7.2)
completed audits of the manufacturing and testing sites and of the active substance manufacturers, with the reports available to the Qualified Person (point 1.7.3)
Imported investigational medicinal products must be manufactured to standards at least equivalent to EU GMP (Article 63(3) of Regulation (EU) No 536/2014).
Licence to practise as a pharmacist, or a completed university degree in pharmacy, chemistry, pharmaceutical chemistry and technology, biology, human or veterinary medicine (§ 15(1) AMG)
at least two years of practical experience in the analysis and quality testing of medicinal products at a site holding a manufacturing authorisation; different requirements apply to vaccines, blood preparations or advanced therapy medicinal products (§ 15(3), (3a) and (4) AMG)
deputies only from persons with the same expert knowledge (§ 16(6) AMWHV)
The authorisation holder notifies the authority of any change of Qualified Person in advance, or without delay if the change is unforeseen (§ 20 AMG).
Named individually
You know who is responsible for you before the contract starts and can reach that person directly. Cover comes from the same team.
Dr. Olaf Mundszinger
Qualified Person (QP) under § 14 AMG
Founder and Managing Director
Dr. Klaus-Peter Kreth
Qualified Person (QP) under § 14 AMG
Qualified Person (QP) under § 14 AMG
Dr. Kai Huwig
Qualified Person (QP) under § 14 AMG
Qualified Person (QP) and Head of Quality Control
Dr. Emmanuel Bey
Qualified Person (QP) under § 14 AMG
Analytical Development
Tatjana Pazer
Qualified Person (QP) under § 14 AMG
Quality Management and Sterile Manufacturing
Dr. Lenka Taylor
Qualified Person (QP) under § 14 AMG
Investigational Medicinal Products and GCP
Sascha Manthei
Qualified Person (QP) under § 14 AMG
Business Development
Dr. Thomas Lutz
Qualified Person (QP) under § 14 AMG
Qualified Person (QP) and Head of Production
Case studies
A marketing authorisation holder needed a Qualified Person (QP) for batch release and, for a period, a Head of Production. We provided both, and business operations conti...
Read case study Mid-sized contract manufacturer of medicinal productsA Swiss contract manufacturer needs batch release for its authorised medicinal products after import into the EU. We release every batch on an ongoing basis and advise on...
Read case study Clinical trial sponsor, small biotech companyA new active substance from a non-EU country was to be used in a phase 1 trial as an investigational medicinal product. We provided GMP oversight, project management, ana...
Read case studyWeighing it up
| Outsourced through A&O Pharma | Hire your own person | |
|---|---|---|
| Time to fill the role | Possible at short notice, as our experts already work as Qualified Persons. Notification to the authority under § 20 AMG is still required. | Depends on advertising, selection, notice periods and induction. |
| Cover for holidays and illness | Several Qualified Persons in-house, so a deputy with expert knowledge under § 15 AMG can be arranged within A&O. | You must provide a second person with expert knowledge under § 15 AMG yourself (§ 16(6) AMWHV). |
| Cost structure | Fees based on the agreed scope; no full-time position needed when demand is lower. | Salary, ancillary costs and training are incurred regardless of workload. |
| Commitment | Contract term agreed in writing, adaptable to a project or transition phase. | Long-term employment; the knowledge stays in the company. |
| Expertise | Experience of batch certification for a range of manufacturers and product types, plus A&O's own GMP-certified laboratory and regulatory affairs. | Detailed day-to-day knowledge of your own product and site; expertise depends on individuals. |
| Imported batches | A&O holds the import authorisation, carries out EU retesting in its own GMP-certified laboratory and certifies the batches, and audits the third-country manufacturer. | You need your own import authorisation; testing takes place in your own laboratory or at a contracted site (§ 14(4) AMG). |
Frequently asked questions
The Qualified Person under § 14 of the German Medicinal Products Act (AMG), known internationally as the QP, ensures that every batch has been manufactured and tested in accordance with the requirements before it is placed on the market (§ 19 AMG, Article 51 of Directive 2001/83/EC). This confirmation is called QP certification or QP release. Without a Qualified Person, no manufacturing or import authorisation is granted.
The Qualified Person is provided for in § 14 AMG, hence the term Qualified Person under § 14 AMG. § 15 AMG sets out the expert knowledge they must demonstrate: education and at least two years of practical experience in testing medicinal products.
The law requires that a Qualified Person is in place and can fulfil their obligations at all times (§ 14(1) AMG); it does not require permanent employment. The competent authority decides case by case whether a given scope is sufficient. A Qualified Person provided by a service company must also be formally integrated into the authorisation holder's quality management system and operations.
The QP must ensure that the batch was manufactured in line with GMP and the marketing authorisation, that the supply chain is documented and that audits of the manufacturing and testing sites are available (Annex 16 points 1.5.4, 1.7.2 and 1.7.3). Unless the EU has an agreement with the exporting country, each batch is also tested in the EU. A&O carries out audits, EU retesting and certification.
Not necessarily one of your own. Under Annex 16 point 1.1, certification is performed by the Qualified Person of a manufacturer or importer named in the marketing authorisation; A&O can take on this role under its own manufacturing authorisation.
A Qualified Person of a manufacturer or importer holding an authorisation under Article 61 of Regulation (EU) No 536/2014. Under Article 62, the QP certifies each batch and, for imports, that it was manufactured to standards at least equivalent to EU GMP. A&O provides this QP certification for clinical trials under its own authorisation.
A licence to practise as a pharmacist, or a completed university degree in one of the subjects listed in § 15 AMG, in each case with at least two years of practical experience in testing medicinal products. Different requirements apply to certain product groups.
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