How do you safeguard batch release and GMP compliance when your Qualified Person is unavailable?
We provide experienced Qualified Persons (QPs) on demand who take over batch release under Art. 51 of Directive 2001/83/EC and §16 AMWHV, assume responsibility for GMP compliance and bridge QP vacancies. Legal responsibility remains with the holder of the manufacturing authorisation; the technical release decision is made by the named QP. The central sticking point is not the availability of the person, but the notification to the competent state authority and the onboarding into the product-specific PQS, without which no batch may be certified.
- Pharma
- Biotech
Overview
When do critical QP bottlenecks arise?
QP activity under Art. 51 Directive 2001/83/EC, §16 AMWHV and EU GMP Guide Annex 16 · Batch Release, Import Release, Interim QP
Last updated: 2026-06-12
Batch release is, under Art. 51 of Directive 2001/83/EC, mandatorily tied to a Qualified Person who is named and notified to the authority. If this person is lost, release grinds to a halt without a back-up QP - and with it the placing on the market. The most common triggers:
- Staff turnover: when the in-house QP leaves the company, months can pass without an authorised release person until the role is refilled and notified under §16 AMWHV.
- Capacity peaks at CDMOs: increased batch volume overloads the available QP capacity, while every batch must be certified individually under Annex 16.
- Project-driven additional load: site takeovers, new product lines or requalifications tie up QP resources that are then missing for routine release in parallel.
- Import release from third countries: releasing batches from non-EU manufacturing under §17 AMWHV requires a QP who confirms the equivalence of the manufacturing conditions - a specialist competence in its own right.
- Illness or vacation: the short-notice absence of the sole named QP blocks batch release entirely.
Services
How we support you
Batch Release & QP Activity
Assumption of the QP activity including batch certification (batch release) for sterile and non-sterile medicinal products under §16 AMWHV and Annex 16, documented through the review of manufacturing records, certificates of analysis and deviations for each batch.
Interim QP Management
Full bridging of a QP vacancy over a defined period: notification as Qualified Person to the authority under §16 AMWHV, integration into the existing PQS, and continuity for ongoing GMP projects and authority communication.
QP for Importers & CDMOs
Import batch release under §17 AMWHV: assessment of manufacturing batches from third countries for GMP conformity and equivalence, plus support in qualifying third-country partners, evidenced by a documented import release decision for each batch.
Project-Based QP Expertise
QP support for site openings, product line takeovers, GMP remediation and inspection readiness, with knowledge transfer and handover-ready documentation for the in-house team.
Learn more →GMP Compliance Review
Assessment of manufacturing and testing documentation against the EU GMP Guide ahead of release, with a named list of the deviations and CAPAs to be closed before certification.
How we work together
What it comes down to
Batch release is the point at which GMP compliance condenses onto a single person: under Art. 51 of Directive 2001/83/EC, a batch may only be placed on the market once a named Qualified Person has certified that manufacturing and testing comply with the marketing authorisation and the GMP principles. This responsibility cannot be split and cannot be automated. If the QP is lost, it does not block a document but the entire placing on the market - and this is precisely why a QP vacancy is not a staffing matter but a regulatory standstill.
The bottleneck rarely arises where you would expect it. An experienced QP is found faster than they can be deployed in a legally effective way: before the first certification under Annex 16, the notification to the state authority under §16 AMWHV, the quality agreement and the onboarding into the product-specific Pharmaceutical Quality System must all be in place. Those who know this sequence plan the bridging early - for import batches also the equivalence assessment under §17 AMWHV - and avoid a situation where a formally available QP fails on a missing authority notification.
Our approach
Our approach
Step
Result
Clarify need & setup
Defined scope of engagement (routine, interim or project), product range and required QP qualification under Art. 49 Directive 2001/83/EC are captured.
Contract & authority notification
Concluded QP service contract, quality agreement and notification of the QP to the competent state authority under §16 AMWHV.
Onboarding into the PQS
Onboarded QP with knowledge of the product-specific SOPs, specifications and the Pharmaceutical Quality System under EU GMP Guide Part I, Chapter 1.
Batch release in operation
Ongoing batch certification under Annex 16, documented per batch including the assessment of open deviations.
Handover or extension
Orderly handback to the in-house QP with status documentation, or a defined extension of the engagement.
Common pitfalls
Where projects commonly fail
The external QP is deployed without being notified to the competent state authority.
Without this notification under §16 AMWHV, batch certification is not legally effective - the release is deemed not to have taken place, regardless of the technical qualification.
Release responsibility is confused with legal responsibility.
The technical release decision is made personally by the QP under Art. 51 Directive 2001/83/EC; the legal responsibility for GMP conformity remains with the holder of the manufacturing authorisation. Failing to separate the two cleanly in the quality agreement creates a liability gap in the event of an inspection.
Import batches are treated like EU batches.
For manufacturing in a third country, §17 AMWHV requires a renewed full analytical testing within the EU unless an MRA recognition applies - a mere visual check of the third-country certificates is not sufficient.
The QP certifies despite open deviations without a documented assessment.
Annex 16 requires the QP to provide a reasoned assessment of every outstanding deviation before release; certification despite an unassessed deviation is a classic inspection finding.
The onboarding into the PQS is underestimated.
Without knowledge of the product-specific specifications and SOPs, the QP cannot stand behind the release decision under Annex 16 - the availability of the person alone does not shorten the bottleneck.
FAQ
Frequently asked questions
Sources
- Directive 2001/83/EC - Community code for medicinal products for human use, Art. 49, 51
- AMWHV (Arzneimittel- und Wirkstoffherstellungsverordnung, German Ordinance on the Manufacture of Medicinal Products and Active Substances) - §16, §17
- AMG (Arzneimittelgesetz, German Medicines Act) - §14, §15
- EudraLex Volume 4, EU GMP Guide - Annex 16 (Certification by a Qualified Person and Batch Release), Part I Chapter 1
- Writer source file: output/expertise-pages/regulatory-compliance/qualified-person-on-demand/qualified-person-on-demand.md
- https://theentourage.de/regulatory-compliance/qualified-person-on-demand/ (existing page content, revised)
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Case Studies
What this looks like in practice
Regulations & standards considered
- Directive 2001/83/EC Art. 51 (obligations of the Qualified Person, batch certification)
- Directive 2001/83/EC Art. 49 (qualification requirements for the Qualified Person)
- Directive (EU) 2017/1572 (GMP principles for medicinal products for human use, replaces Directive 2003/94/EC)
- AMWHV §16 (activity of the Qualified Person, batch release)
- AMWHV §17 (placing on the market, import release from third countries)
- AMG §14/§15 (manufacturing authorisation and requirements for the Qualified Person)
- EU GMP Guide Annex 16 (certification by the Qualified Person and batch release)
- EU GMP Guide Part I, Chapter 1 (Pharmaceutical Quality System)
Have a concrete project?
Briefly outline your situation. We'll respond with an initial assessment, usually within one business day.
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info@theentourage.de
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