Services · Medicinal Product Release · Roles we take on
Contract Qualified Person: batch certification, import and interim QP
Anyone who manufactures, imports or releases medicinal products needs a Qualified Person under Section 14 AMG. A&O certifies your batches under its own manufacturing and import authorisation, including clinical trial supplies and third-country imports, 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, releases or imports medicinal products from third countries needs at least one Qualified Person under Section 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 (Section 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 release your batches under A&O's own manufacturing authorisation pursuant to Section 13 AMG: authorised medicinal products under Annex 16, investigational medicinal products under Regulation (EU) No 536/2014. You do not need your own Qualified Person 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 fill a full-time position. We agree the level of presence so that the obligations can be fulfilled at all times, as Section 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 retest) and certifies them. A&O oversees GMP-compliant manufacturing at the third-country manufacturer and qualifies manufacturers through audits. Testing, supply chain and release are handled in one place.
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.
We decide whether A&O certifies, a person joins your site or A&O imports. 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 batch release site in the marketing authorisation. If an A&O person is named in your authorisation, you notify the authority in advance (Section 20 AMG).
Documents, specifications and the supply chain are reviewed, then regular batch certification begins.
What the law requires
Anyone who manufactures medicinal products commercially or professionally needs a manufacturing authorisation under Section 13 of the German Medicinal Products Act (AMG). Under Section 4(14) AMG, manufacturing expressly includes batch release. Section 72 AMG applies the same to imports from outside the EU and EEA. Under Section 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 Section 19 AMG, the Qualified Person ensures that every batch has been manufactured and tested in accordance with medicines law and confirms this in a continuous register before the batch is placed on the market. The release process is governed by Section 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, Section 17 AMWHV). This can only be waived where the EU has an agreement with the exporting country. Annex 16 also requires:
Imported investigational medicinal products must be manufactured to standards at least equivalent to EU GMP (Article 63(3) of Regulation (EU) No 536/2014).
Any change of Qualified Person is notified to the authority in advance, or without delay if unforeseen (Section 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
Development Analytics
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, at times, a Head of Production. We provided both, and business operations continued...
Read case Medium-sized company. Contract manufacturer of medicinal productsA Swiss contract manufacturer needs batch release for its authorised medicinal products after import into the EU. We release on an ongoing basis and advise on changes and...
Read case Sponsor of clinical trials, small biotech companyA new active substance from a non-EU country was to go into a phase 1 trial as an investigational medicinal product. We provided GMP oversight, project management, analyt...
Read caseWeighing it up
| External via A&O Pharma | Hire your own person | |
|---|---|---|
| Time to fill the role | Possible at short notice, as the experts already work as Qualified Persons. Notification to the authority under Section 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 expertise under Section 15 AMG can be arranged within A&O. | You must provide a second person with expertise under Section 15 AMG yourself (Section 16(6) AMWHV). |
| Cost structure | Fees based on the agreed scope, no full-time position when demand is lower. | Salary, ancillary costs and training are incurred regardless of workload. |
| Commitment | Contractually agreed term, adaptable to a project or transition phase. | Long-term employment relationship, knowledge stays in the company. |
| Expertise | Experience from releases for various manufacturers and product types, plus a GMP-certified laboratory and regulatory affairs at A&O. | Detailed day-to-day knowledge of your own product and site, expertise depends on individuals. |
| Imported batches | Import authorisation, EU retest in its own GMP-certified laboratory and certification at A&O, plus audits at the third-country manufacturer. | Your own import authorisation is required, testing is carried out in your own laboratory or at a contracted site (Section 14(4) AMG). |
Frequently asked questions
The Qualified Person under Section 14 of the German Medicinal Products Act (AMG) ensures that every batch has been manufactured and tested in accordance with the rules before it is placed on the market (Section 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 Section 14 AMG, hence the term Qualified Person under Section 14 AMG. Section 15 AMG sets out the expertise 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 (Section 14(1) AMG); the wording does not mention permanent employment. Whether a given scope is sufficient is assessed by the competent authority case by case. 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, 1.7.3). Without 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 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, they certify each batch, and for imports also the at least equivalent manufacturing standards. A&O carries out this QP release 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 Section 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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