External QP and batch certification

An external Qualified Person certifies batches and takes responsibility under Section 14 AMG.

14 providers with evidence Sourced from law and guidelines · as of 10.11.2026 View providers

Partners for External QP and batch certification

Paid placements · labelled

3 partner positions freeYour company at the top of External QP and batch certification €1,500 per year per service (Founding price) →

In brief

Before a batch of a medicinal product is placed on the market, a Qualified Person (QP, in German law the Sachkundige Person) must confirm that it was manufactured and tested in accordance with Good Manufacturing Practice (GMP) and, for authorised medicinal products, that it complies with the marketing authorisation. Only then may the batch be released.

Anyone in Germany who holds a manufacturing or import authorisation needs at least one such person. The law does not require permanent employment, but it does require that the Qualified Person can fulfil their duties at all times. An external QP therefore takes on the task under contract, often for smaller companies, for imports or as a deputy.

Who needs it

Every holder of a manufacturing or import authorisation under the German Medicines Act (Arzneimittelgesetz, AMG).

Legal basis

Sections 14, 15 and 20 AMG, Section 16 of the German manufacturing ordinance (AMWHV) and Annex 16 of the EU GMP Guide.

Typical scope

Review of the manufacturing and testing records and certification of every single batch before it is placed on the market.

What matters

The QP must be able to fulfil their duties at all times, including during holidays or illness, through an arranged deputy.

When an external QP makes sense

An external QP is particularly worthwhile where an in-house full-time Qualified Person would not be fully occupied or where capacity is lacking at short notice. Typical cases are:

Small manufacturers and start-ups, for whom an in-house full-time QP would be too much.
Imports from third countries: medicinal products from outside the EU and the EEA need certification by a QP in the EU before they are placed on the market here.
Investigational medicinal products for clinical trials: medicinal products for trials are also certified by a QP, under separate GMP rules for investigational medicinal products.
Deputising during holidays, illness or a change of your own QP.
Peaks, for example at market entry or when many batches are due at once.

Legal basis

In Germany, the Qualified Person is mainly governed by the German Medicines Act (AMG) and the German Ordinance on the Manufacture of Medicinal Products and Active Substances (Arzneimittel- und Wirkstoffherstellungsverordnung, AMWHV). For imports, Section 72 AMG refers to the same provisions, so that a pure importer also needs a Qualified Person.

Section 14 AMG

The manufacturing authorisation is refused if no person with the necessary expert knowledge is available or if that person cannot fulfil their duties at all times.

Section 15 AMG

Which education and which practical experience in the testing of medicinal products are required for the expert knowledge.

Section 20 AMG

A planned change of the Qualified Person must be notified to the authority in advance, an unforeseen change without delay.

Section 16 AMWHV

The release of a batch for placing on the market by the Qualified Person, including the rules on deputies.

EU GMP Guide, Annex 16

How certification by the QP and batch release work in detail, in force since April 2016.

Investigational medicinal products

Regulation (EU) No 536/2014, Delegated Regulation (EU) 2017/1569 and the Commission’s GMP guidelines for investigational medicinal products.

How the collaboration works

The collaboration with an external QP usually begins a few weeks before the first certification, because the QP first needs to get a picture of the quality system and the supply chain. After that, it usually follows these steps:

Initial meeting and review

The products, sites and authorisations concerned are clarified. The QP looks at the quality system and the supply chain, because where manufacturing is split across sites, the QP must be satisfied that the manufacturers involved are capable.

Contract

A written contract defines who is responsible for what and which resources the authorisation holder makes available to the QP.

Naming the QP to the authority

The QP is named for the authorisation. A change must be notified to the competent authority of the federal state (Land), together with evidence of the expert knowledge.

Ongoing certification

For each batch, the QP reviews the signed manufacturing and testing records and certifies the batch, often supplemented by visits to the manufacturer or contract laboratory.

Important

The Qualified Person remains personally responsible for certification, even when relying on confirmations from others in multi-stage manufacturing. In the event of short-term unavailability, only someone who has the expert knowledge under Section 15 AMG may act as deputy. Arrange the deputy in the contract from the outset.

What to look for

When choosing a QP, what counts besides formal expert knowledge is above all whether the QP knows your products and is available when batches need to be certified urgently. These questions help with the comparison:

Questions to ask the provider

Does the person have experience with your dosage form, such as solid, sterile, biological or investigational medicinal products?

How is deputising arranged if the QP is unavailable?

How quickly is a batch certified once complete documentation has been received?

Does the QP work alone or in a team that can absorb bottlenecks?

Do they know your competent authority, and have they already accompanied inspections?

How is billing done: monthly flat fee, daily rate or per batch?

Frequently asked questions

May a QP work for several companies? +

The law does not rule it out, and it is common for external QPs. What matters is that the person can fulfil their duties for each company at all times. Whether this is achievable given the number of their mandates can be checked by the authority when granting the authorisation.

What is the difference between certification and release? +

Annex 16 of the EU GMP Guide refers to the certification of the batch by the QP, which is recorded in a register or equivalent document before the batch is released for sale. The German AMWHV calls this step release for placing on the market (Freigabe zum Inverkehrbringen). In practice, the two terms are often used interchangeably.

Does a pure importer also need a QP? +

Yes. Anyone who commercially imports medicinal products from countries outside the EU and the EEA needs an import authorisation under Section 72 AMG, and the provisions on the Qualified Person apply accordingly.

Sources

Every statement in this text was checked against these primary sources (as of 10.11.2026). Laws, guidelines and authority websites, no advertising.

Providers

companies name this service on their own website.

A&O Pharma GmbH Efringen-Kirchen
Actrevo GmbH Hamburg-Altstadt
Ayna Analytics GmbH Kleinmachnow
Canify AG Leipheim
Diapharm GmbH & Co. KG Muenster
MSK-Pharmalogistic GmbH Heppenheim

View all

Related services

Providers

Filter by federal state and type →

Company	Location	EvidenceQuote from the company’s website (German)	Credentials
A&O Pharma GmbH A&O Pharma GmbH, based in Efringen-Kirchen with sites in Itzehoe and Lörrach, provides service support to pharmaceutical companies, including batch certification by Qualified Persons, regulatory affairs, GMP consulting and GMP-certified analytics.	Efringen-Kirchen	Evidenced „stellt Ihnen eine namentlich benannte Sachkundige Person mit eigener Herstellungserlaubnis (§ 13 AMG), die Ihre Chargendokumentation prüft und mit ihrer Zertifizierung persönlich freigibt“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Actrevo GmbH actrevo GmbH, based in Hamburg, provides pharmaceutical companies with EU marketing authorisation procedures, import services and Qualified Person batch certification. The company also markets its own medicinal products, including Alltrevo, Hialurom and Rafaject.	Hamburg-Altstadt Hamburg	Evidenced „Import, analytische Freigabeuntersuchungen im eigenen Labor und EU-QP-Freigabe – alles aus einer Hand.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Ayna Analytics GmbH Ayna Analytics GmbH, based in Kleinmachnow, operates a testing laboratory that analyses medicinal products non-destructively by near-infrared spectroscopy for pharmacies and pharmaceutical companies. The laboratory also carries out stability studies and batch certification.	Kleinmachnow Brandenburg	Evidenced „Chargenfreigabe durch unsere Sachkundige Person nach §14 AMG für Arzneimittel (auch BtM)“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Canify AG Canify AG (Leipheim) produces medical cannabis in a former NATO bunker under GMP and GACP and offers contract manufacturing, laboratory analytics and batch certification for partners. The company also distributes its own products.	Leipheim Bayern	Evidenced „supplier qualification, laboratory analysis and stability testing, import, GMP processing, batch release, warehousing and distribution.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Diapharm GmbH & Co. KG Diapharm GmbH & Co. KG, based in Münster, advises pharmaceutical companies on regulatory affairs, GMP quality management and pharmacovigilance, and also assumes responsibility functions such as acting as an external Qualified Person.	Muenster Nordrhein-Westfalen	Evidenced „übernehmen die Verantwortung als externe QP in Qualitätsmanagementsystemen der Klienten“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
MSK-Pharmalogistic GmbH MSK Pharmalogistic GmbH, based in Heppenheim, is a full-service provider of pharmaceutical logistics, offering storage, kitting, packaging and quality management. The company operates storage facilities in Heppenheim and Bensheim under GDP requirements.	Heppenheim Hessen	Evidenced „Bei Bedarf übernehmen wir die Legal-Funktionen in Ihrem Unternehmen, beispielsweise als Head of Quality Management- (QMB), Großhandelsbeauftragten oder Qualified Person“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Nuvisan GmbH Nuvisan GmbH, based in Neu-Ulm, is a contract research organisation (CRO) with laboratories in Germany and France. It conducts clinical trials and recruits trial participants at its own clinical research sites.	Neu-Ulm Bayern	Evidenced „Nuvisan offers batch release overseen by an EU-qualified person (QP). The QP services include batch certification of commercial products for European market release.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
PROMEDIPHARM GmbH PROMEDIPHARM GmbH in Bensheim has been an independent service provider for pharmaceutical development and marketing authorisation since 1994. The company supports production and batch certification at contract manufacturers, as well as quality systems and regulatory inspections.	Bensheim Hessen	Evidenced „We support your ongoing commercial production at contract manufacturer sites including batch release activities.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
PharmaKorell GmbH PharmaKorell GmbH, based in München and Lörrach, advises the pharmaceutical industry on GMP, GDP and ISO 13485, provides Qualified Persons for batch certification, and carries out audits. The company also offers storage, primary packaging and labelling services.	München Bayern	Evidenced „Für die Chargenfreigabe/ –zertifizierung von Arzneimitteln und Wirkstoffen bieten wir zwei Optionen an.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Rotop Pharmaka GmbH ROTOP Pharmaka GmbH, based in Dresden-Rossendorf, manufactures radiopharmaceuticals and cold kits for nuclear medicine and also offers these services as a contract development and manufacturing organisation (CDMO) partner for clients.	Dresden Sachsen	Evidenced „QP-Dienstleistungen (Qualified Person)“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
THE QP SERVICES GmbH THE QP SERVICES GmbH in Taucha provides external Qualified Person services to pharmaceutical companies, including batch certification, product release responsibility and GMP quality consultancy, also under its own manufacturing and import authorisation.	Taucha Sachsen	Evidenced „Wenn Sie keine eigene Herstellungs- oder Einfuhrerlaubnis besitzen, führen wir die Freigabe bzw. den Import Ihrer Arzneimittel in die EU basierend auf unserer eigenen Herstellungs- und Einfuhrerlaubnis durch.“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
TentaConsult Pharma & Med GmbH TentaConsult Pharma & Med GmbH, based in Münster with a site in Planegg, advises life sciences companies on regulatory affairs, quality management and pharmacovigilance. Its services also include the external assumption of the Qualified Person (QP) and Qualified Person for Pharmacovigilance (QPPV) roles.	Muenster Nordrhein-Westfalen	Evidenced „Wir unterstützen Sie als externe Sachkundige Person (QP)“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
Tentamus Pharma & Med Deutschland GmbH	Oldenburg Niedersachsen	Evidenced „Unsere sachkundigen Personen (Qualified Person gemäß Direktive 2001/83/EG) testieren auf Wunsch die durchgeführten Freigabeprüfungen zur Bezugnahme gemäß Annex 16 des EU-GMP-Leitfadens“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate
picopharma GmbH picopharma GmbH in Weyarn provides GMP services, including packaging, labelling and batch certification of clinical trial medicinal products, import and release of commercial products, and the establishment of quality management systems. It also offers a Qualified Person (QP) service.	Weyarn Bayern	Evidenced „Picopharma hat mich (mein Arbeitgeber) zweimal über mehrere Monate mit einem QP-Service unterstützt. Dirk hat sich schnell in unsere lokalen Prozesse eingearbeitet“ Source · 10 Nov 2026 ↗	Manufacturing authorisation GMP certificate

Order: partners (paid, labelled), then alphabetical. No rating.