Services · Medicinal Product Release
Without release by a Qualified Person under § 14 AMG, no batch of a medicinal product may be placed on the market. If this function is not available in-house, the medicinal product cannot be released. A&O Pharma provides you with a named Qualified Person (QP) holding its own manufacturing authorisation (§ 13 AMG), who reviews your batch documentation and personally releases it by certification. If your company does not hold a manufacturing authorisation, we can also carry out the batch release under A&O Pharma's manufacturing authorisation.
Non-binding and confidential. Answer in one to two working days.
A finished batch that cannot be released for the market costs a great deal of money every day.
The question that matters
Yes. You can transfer batch certification to another company, clearly regulated by contract through a Service Agreement, supplemented by a Quality Technical Agreement (QTA) setting out the allocation of responsibilities. Overall responsibility for the medicinal product remains with the marketing authorisation holder (MAH) or the sponsor of the clinical trial. This is precisely what makes outsourcing attractive for companies without their own manufacturing authorisation: you get the release without having to maintain the § 13 AMG authorisation and the Qualified Person yourself.
Under Annex 16 of the EU GMP Guide, the Qualified Person (QP) confirms by certification that a batch complies with the requirements of Good Manufacturing Practice and with the marketing authorisation (or clinical trial authorisation). The QP ensures the batch was manufactured and tested in accordance with the applicable legislation and the dossiers approved by the authorities. Without this release, no batch of a medicinal product may be placed on the market or used in a clinical trial.
A&O Pharma holds its own manufacturing authorisation under § 13 AMG, under which batch releases can be carried out in accordance with CTR 536/2014 and Annex 16 or AMWHV § 16. The release can be carried out either under your own manufacturing authorisation or under ours, whichever you prefer.
All responsibilities and activities associated with batch release:
Process
4 Steps, a fixed contact person, no surprises.
Arrange an initial consultationYou describe the product, dosage form and timeframe. We tell you what we need for the batch release.
We review the existing documentation and define the release process together with you.
Any missing tests can be carried out in our GMP laboratory in Itzehoe, documented in accordance with GMP.
The Qualified Person certifies the batch. It may then go to market or into the clinical trial.
Typical initial situations
You have a product but no in-house QP. A full-time position is not worthwhile, and the trial will not wait.
Your product is finished. For the EEA market, you need a QP based in the EU who bears responsibility for batch release under European law.
Your own Qualified Person is unavailable or has resigned. Releases cannot wait regardless.
Investigational medicinal product for phase 1, 2 or 3 ready, trial start imminent. You need the release under CTR 536/2014, reliable and GMP-compliant.
Responsibility
You get the name, the legal role and the extension of the person who takes over your topic. Before the start of the contract, not afterwards, and not as a team, but as a person.
Founder and Managing Director
Key areas
Doctorate in analytical chemistry, degree in pharmaceutical sciences and chemistry
Investigational Medicinal Products and GCP
Key areas
Doctorate in clinical analytics, specialist pharmacist for clinical pharmacy
Business Development
Key areas
Training as a bank clerk, degree in pharmacy, licence to practise as a pharmacist, Master of Business Administration (MBA)
Qualified Person (QP) and Head of Quality Control
Key areas
Degree and doctorate in chemistry, further education in pharmacy to attain expert knowledge under § 15 AMG
Qualified Person (QP) and Head of Production
Key areas
Degree in pharmacy, licence to practise as a pharmacist, doctorate in pharmaceutical chemistry
Case studies
Anonymised projects from exactly this service, with initial situation, procedure and the final outcome.
Sponsor of clinical trials, small biotech company
Active substance manufacture in a non-EU country, formulation development, analytics and QP release: a project combining almost all of our services.
Read the full case studyLarge international pharmaceutical company
Analytical method transfer to our laboratory, EU retesting, import and warehousing with a logistics partner. Launch planned for 2027.
Read the full case studyInnovative biotech company in the field of cancer therapeutics
A renowned research institution is setting up a manufacturing facility for personalised peptide vaccines, we support them from regulatory affairs thro...
Read the full case studyMid-sized company. Marketing authorisation holder and pharmaceutical entrepreneur
Following a personnel shortage, our appointed persons secured batch release and the QM system, and business operations continued without interruption.
Read the full case studyMedium-sized company. Contract manufacturer of medicinal products
Continuous release of commercial medicinal products following import into the EU, plus advice on changes and operational QM support.
Read the full case studySponsor of clinical trials, small biotech company
A sponsor without its own QP needed GMP oversight for manufacture in a non-EU country, the IMPD and release of the investigational medicinal product,...
Read the full case studyWe clarify your questions in the initial consultation. Dr. Olaf Mundszinger takes the time for it.
Arrange an initial consultationAnnex 16 of the EU GMP Guide governs certification by the Qualified Person. In it, the QP confirms that a batch complies with both the requirements of Good Manufacturing Practice and the marketing authorisation, that is, the marketing authorisation itself or the clinical trial authorisation. Only with this certification may the batch be placed on the market.
Yes. We release investigational and comparator medicinal products for phase 1 to 3 trials under CTR 536/2014. We remain flexible according to timing, workload and number of batches.
Both are possible. The release can be carried out under your own manufacturing authorisation. However, A&O Pharma also holds its own authorisation under § 13 AMG, under which batch releases can be carried out in accordance with Annex 16 or AMWHV § 16, which requires corresponding registration in the marketing authorisation documentation.
Yes. That is precisely what we provide: a named Qualified Person under § 14 AMG from our company. She reviews your batch documentation and personally releases the batch by certification. The Qualified Person is integrated into your quality management system and works under your manufacturing authorisation.
We hold the manufacturing and import authorisation under § 13 AMG (MIA). This foundation is already fully in place in-house at two sites and does not need to be established. It is the prerequisite for our Qualified Person to be able to certify and release your batch at all.
If a batch is finished and only the release is outstanding, short-notice releases are possible. This requires complete, auditable batch documentation. As soon as we have the documentation, we begin the assessment, for time-critical cases, please contact us directly.
Deviations and out-of-specification findings are assessed before the release decision is made. Our Qualified Person examines whether the finding affects marketability and decides on this basis, in dialogue with you and, where necessary, backed by analytics from our GMP-certified laboratory. Only what can be justified is released.
Yes. For imports from third countries without a Mutual Recognition Agreement, we carry out the retesting required in the EU before the Qualified Person certifies the batch in accordance with Annex 21. Only then is the batch considered marketable. We cover the EU retesting with our GMP-certified laboratory.
Services that are often used together
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