Services · GMP and GxP Consulting & QA Support · Roles we take on
GMP consultant: expert support for validation, audits and inspections
A GMP subject matter expert (SME) handles qualification, validation, computer system validation (CSV), GxP audits, inspection readiness and GMP documentation when you lack in-house capacity or experience. At A&O, these specialists work under GMP themselves, backed by our own manufacturing authorisation and GMP-certified laboratory in Itzehoe.
Key points at a glance
Reviewed by Dr. Olaf Mundszinger
Legal basis checked against the statutory text, as of October 2026
A GMP subject matter expert (SME) supports qualification and validation, computer system validation, GxP audits, inspection readiness and GMP documentation.
You decide both the scope and the form of support from our experienced GMP experts.
Responsibility remains with the manufacturer, who reviews and approves plans, protocols and documentation.
At A&O Pharma
We take on a defined project: qualification of equipment and premises from DQ to PQ, process and cleaning validation, analytical method validation, computer system validation or a manufacturing transfer. Preparation for a GMP inspection and responses to audit findings can also be commissioned as a project.
We work within your quality system, for example on CAPA, deviations, change control, complaints, self-inspections and PQR, or help you set up a quality management system. This includes documents such as SOPs, the Site Master File and CMC documentation. If a quality assurance position is vacant, our interim management is also an option.
We audit suppliers and service providers against GMP, GDP or GCP and support supplier qualification. Our report gives you the basis for your assessment, which under Chapter 7 remains your responsibility as the contract giver.
Process
You tell us the reason and timeframe, such as an upcoming inspection, a project or an audit. We get back to you within 1 to 2 days.
Scope, schedule and responsibilities are set out in a written contract, as required by Chapter 7 of the EU GMP Guide and § 9 AMWHV.
Risk assessment, protocols, execution and reports. Review and approval stay with you.
You receive the report and documents. On request, we support you during the inspection and with the responses to findings.
What the law requires
Anyone who manufactures medicinal products commercially or professionally needs a manufacturing authorisation under § 13 of the German Medicinal Products Act (AMG). § 3 of the German Ordinance on the Manufacture of Medicinal Products and Active Substances (AMWHV) refers to the EU GMP Guide. Wholesale distribution is governed by the EU Guidelines on Good Distribution Practice (GDP), which likewise require self-inspections, supplier qualification and validated systems. GMP, GDP and GCP are often grouped together under the term GxP.
Chapter 2 of the Guide requires consultants to have adequate education, training and experience for the subject they advise on. Under Chapter 7 and § 9 AMWHV, every outsourced activity needs a written contract.
A consultant may prepare protocols and documents, carry out qualification and validation, and conduct audits.
The manufacturer remains responsible for the pharmaceutical quality system and for reviewing and approving protocols supplied by a third party (Annex 15, point 2.6).
Batch certification remains with the Qualified Person under § 14 AMG.
The validation master plan defines the programme. Qualification runs from user requirements (URS) through DQ, factory acceptance testing (FAT) and site acceptance testing (SAT), IQ, OQ and PQ. The programme also covers process and cleaning validation, validation of analytical test methods and change control. Scope and depth are based on a documented risk assessment. Retrospective validation is no longer considered acceptable.
Under Annex 11, applications must be validated and IT infrastructure qualified. A risk assessment determines the extent of validation and of data integrity controls. Requirements include a system inventory, access controls, audit trails that are regularly reviewed, and periodic evaluation of whether a system remains validated. Drafts of a revised Annex 11, a revised Chapter 4 and a new Annex 22 on artificial intelligence were open for consultation from July to October 2025.
Chapter 4 distinguishes instructions such as specifications and SOPs from records. The Site Master File is also part of the documentation. Under Chapter 9, self-inspections must follow a pre-arranged programme and be recorded, and independent audits by external experts can also be useful. Under § 64 AMG, sites holding a manufacturing or import authorisation are generally inspected by the competent authority every two years.
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.
Sascha Manthei
Business Development
Dr. Olaf Mundszinger
Founder and Managing Director
Leidy Fajardo
Risk Assessment and GMP Documentation
Dr. Emmanuel Bey
Analytical Development
Tatjana Pazer
Quality Management and Sterile Manufacturing
Dr. Klaus-Peter Kreth
Qualified Person (QP) under § 14 AMG
Alexander Trautmann
GMP Consulting and Training
Dr. Thomas Lutz
Qualified Person (QP) and Head of Production
Dr. Kai Huwig
Qualified Person (QP) and Head of Quality Control
Case studies
A research institution is setting up a GMP manufacturing facility for personalised peptide vaccines. We are supporting it from regulatory classification through to qualif...
Read case study Mid-sized company, marketing authorisation holderA marketing authorisation holder is planning to change its manufacturer. We reviewed the CMC documentation, made recommendations on selecting a contract manufacturer and...
Read case study Clinical trial sponsor, small biotech companyA 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, project management, ana...
Read case studyWeighing it up
| Outsourced through A&O Pharma | Hire your own person | |
|---|---|---|
| Availability | At short notice for a project or phase, without a recruitment process. | Available only after recruitment and induction, then permanently on site. |
| Breadth of expertise | Access to several specialists, for example for qualification, computer system validation and audits. | One person covers only what they know themselves. |
| Knowledge of your site | Needs time to become familiar with your equipment, processes and systems. | Knows the equipment, processes and contacts from day-to-day work. |
| Outside view | Looks at processes without the blind spots of routine. Chapter 9 notes that independent audits by external experts can be useful. | Knows why processes are set up as they are, but more easily overlooks what has become routine. |
| Responsibility | Works to a written contract. The quality system and approvals remain with you. | Can hold roles in your quality system on a permanent basis. |
| Cost | Costs arise only for the agreed service. If demand stays high over time, a permanent position may be more economical. | Fixed staff costs, even in periods with little project work. |
Frequently asked questions
A GMP consultant helps manufacturers meet the requirements of Good Manufacturing Practice, for example in qualification, validation, audits, inspection readiness and documentation. The consultant works under a written contract, while responsibility for the quality system stays with the manufacturer.
GMP is Good Manufacturing Practice. GxP groups several good practices together, including GMP, Good Distribution Practice (GDP) for storage and transport, and Good Clinical Practice (GCP) for clinical trials. GxP consulting therefore usually covers more than manufacturing.
Design qualification (DQ) shows that the design meets the user requirements and GMP; installation qualification (IQ) shows that the equipment is installed correctly. Operational qualification (OQ) shows that it performs as intended across its operating range; performance qualification (PQ) shows that it works effectively and reproducibly in the process.
Computer system validation is documented evidence that a computerised system reliably performs its intended function. Annex 11 requires a risk assessment that also covers data integrity, access controls, regularly reviewed audit trails, data back-up and periodic evaluation. A&O also validates the computerised systems in its own laboratory in Itzehoe.
Yes. Under Annex 15, protocols supplied by a third party must be checked by the responsible personnel at the manufacturing site for suitability and compliance with internal procedures before they are approved.
The usual starting point is a self-inspection or audit covering documentation, open deviations and CAPA, the status of qualification and validation, computerised systems and the control of outsourced activities. After the inspection, the findings are answered with an action plan.
Under § 64 AMG, sites holding an authorisation under § 13 or § 72 AMG are generally inspected every two years. Unannounced inspections are provided for, among other cases, where falsification or serious defects are suspected.
Chapter 9 of the EU GMP Guide provides for self-inspections to be carried out independently and in detail by designated competent persons from the company. Independent audits by external experts may also be useful. Every self-inspection must be recorded with its observations and actions.
More roles we take on
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