Services · QP Batch Release
Without certification by a Qualified Person under § 14 AMG, no batch of a medicinal product may be placed on the market. If you do not have this function in-house, your product cannot be released. A&O Pharma holds its own manufacturing authorisation (§ 13 AMG) and provides a named Qualified Person (QP), who reviews your batch documentation and personally certifies the batch. If your company does not hold a manufacturing authorisation, we can also release the batch under A&O Pharma's own authorisation.
No obligation, in confidence. We reply within one to two working days.
A finished batch that cannot be released for sale costs a great deal of money every day.
The question that matters
Yes. You can outsource batch certification to another company, set out in a service agreement and a quality agreement (technical agreement) that defines who is responsible for what. Overall responsibility for the medicinal product remains with the marketing authorisation holder (MAH) or the clinical trial sponsor. This is exactly what makes outsourcing attractive for companies without their own manufacturing authorisation: you get batch release without having to maintain a § 13 AMG authorisation and a Qualified Person yourself.
Under Annex 16 of the EU GMP Guide, the Qualified Person (QP) certifies that a batch complies with Good Manufacturing Practice and with the marketing authorisation (or, for investigational medicinal products, the clinical trial authorisation). The QP ensures that the batch has been manufactured and tested in accordance with the applicable legislation and the product dossiers approved by the authorities. Without this certification, 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 and import authorisation (MIA) under §§ 13 and 72 AMG, under which batches can be certified in accordance with CTR 536/2014 and Annex 16 or § 16 AMWHV. Batch release can take place either under your own manufacturing authorisation or under ours.
All responsibilities and activities related to batch release:
QP certification of investigational and comparator medicinal products for phase 1 to 3 trials under CTR 536/2014, flexible in timing, workload and number of batches.
EU batch release of authorised commercial medicinal products under Annex 16 of the EU GMP Guide or § 16 AMWHV.
Oversight of GMP-compliant manufacturing and testing across the entire manufacturing process, including GDP-compliant transport along the whole supply chain, from active substance manufacture to shipment to the distribution centre, pharmacies or clinical trial sites. We carry out audits and keep the whole supply chain in view.
Qualification of your suppliers and manufacturers, whether active substance manufacturers, manufacturers of packaging materials or excipients, or contract manufacturers and contract laboratories. We qualify and audit using a risk-based approach.
§§ 13 and 72 AMG, our own manufacturing and import authorisation (MIA) at two sites, Efringen-Kirchen and Itzehoe.
§ 14 AMG, named Qualified Persons in-house.
CTR 536/2014, investigational medicinal products for phase 1 to 3 clinical trials.
Annex 16 EU GMP Guide, certification by a Qualified Person and batch release.
§ 16 AMWHV, batch release under the German Ordinance on the Manufacture of Medicinal Products and Active Substances (AMWHV).
§ 13 AMG, GMP-certified laboratory for accompanying analytical testing.
Roles we take on
Process
4 steps, one dedicated contact, no surprises.
Book an initial consultationYou tell us about the product, dosage form and timeframe. We tell you what we need for batch release.
We review the existing documentation and define the release process together with you.
Any missing tests can be performed in our GMP laboratory in Itzehoe and documented in line with GMP.
The Qualified Person certifies the batch. It can then be placed on the market or used in the clinical trial.
Typical starting points
You have a product but no in-house QP. A full-time position does not pay off, and the trial will not wait.
Your product is ready. For the EEA market, you need a QP based in the EU who takes responsibility for batch release under EU law.
Your own Qualified Person is unavailable or has resigned, but releases cannot wait.
Your phase 1, 2 or 3 investigational medicinal product is ready and the trial is about to start. You need reliable, GMP-compliant release under CTR 536/2014.
Responsibility
You get the name, statutory role and direct phone number of the person handling your project before the contract starts, not afterwards. A named person, not a team.
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 analysis, specialist pharmacist in clinical pharmacy
Business Development
Key areas
Banking apprenticeship, 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, postgraduate pharmacy programme to acquire the expert knowledge required 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
Qualified Person (QP) under § 14 AMG
Key areas
Licence to practise as a pharmacist, doctorate in pharmaceutical analysis, specialist pharmacist in pharmaceutical analysis
Analytical Development
Key areas
Doctorate in pharmaceutical chemistry
Quality Management and Sterile Manufacturing
Key areas
Degree in pharmacy, licence to practise as a pharmacist, pharmaceutical technical assistant
Case studies
Anonymised projects from this service: starting point, approach and outcome.
Clinical trial sponsor, small biotech company
A 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, pro...
Read the full case studyLarge international pharmaceutical company
A marketing authorisation holder is planning to launch a medicinal product made in a non-EU country. We handle method transfer, EU retesting, import w...
Read the full case studyInnovative biotech company in cancer therapeutics
A research institution is setting up a GMP manufacturing facility for personalised peptide vaccines. We are supporting it from regulatory classificati...
Read the full case studyMid-sized pharmaceutical company and marketing authorisation holder
A marketing authorisation holder needed a Qualified Person (QP) for batch release and, for a period, a Head of Production. We provided both, and busin...
Read the full case studyMid-sized contract manufacturer of medicinal products
A Swiss contract manufacturer needs batch release for its authorised medicinal products after import into the EU. We release every batch on an ongoing...
Read the full case studyClinical trial sponsor, small biotech company
Active substance from a non-EU country, investigational medicinal product for a trial in several European countries: we provided GMP oversight, the IM...
Read the full case studyWe will answer your questions in an initial consultation. Dr. Olaf Mundszinger will take the time to go through them with you.
Book an initial consultationAnnex 16 of the EU GMP Guide governs certification by the Qualified Person. The QP certifies that a batch complies with GMP and with the marketing authorisation (or, for investigational medicinal products, the clinical trial authorisation). Only once it has been certified may the batch be placed on the market.
Yes. We certify investigational and comparator medicinal products for phase 1 to 3 trials under CTR 536/2014, with flexibility on timing, workload and number of batches.
Both are possible. The release can take place under your own manufacturing authorisation. A&O Pharma also holds its own manufacturing and import authorisation (MIA) under §§ 13 and 72 AMG, under which batches can be certified in accordance with Annex 16 or § 16 AMWHV. This requires A&O Pharma to be named as the batch release site in the marketing authorisation documents.
Yes. That is exactly why we provide a named Qualified Person under § 14 AMG from our own team. The QP reviews your batch documentation and personally certifies the batch. If you hold your own manufacturing authorisation, the QP works under it, integrated into your quality management system. If you do not, the QP certifies the batch under our own authorisation.
We hold a manufacturing and import authorisation (MIA) under §§ 13 and 72 AMG. It is already fully in place at two of our sites and does not need to be set up first. This means our Qualified Person can certify and release your batch even if you do not hold a manufacturing authorisation yourself.
If a batch is complete and only the release is outstanding, release at short notice is possible. This requires complete batch documentation that is ready for review. We start the assessment as soon as we have the documents. For time-critical cases, please contact us directly.
Deviations and out-of-specification results are assessed before the release decision is made. Our Qualified Person assesses whether the finding affects whether the batch can be placed on the market and decides on that basis, in consultation with you and, where necessary, backed by testing in our GMP-certified laboratory. We only release what we can justify.
Yes. For imports from third countries without a mutual recognition agreement (MRA), we carry out the EU retesting required before the Qualified Person certifies the batch in accordance with Annex 21. Only then can the batch be placed on the market. We perform EU retesting in our own GMP-certified laboratory.
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