Services · Operational QM/QA Support
Overdue PQRs, a backlog of deviations, CAPAs that no one can keep up with, and no hands to work through them reliably. A&O Pharma takes on your operational QM work with named points of contact and statutory roles (Qualified Person under § 14 AMG, Head of Quality Control or Head of Production) in-house, so your process quality remains continuously assured and your team gets some breathing room back.
Non-binding and confidential. Answer in one to two working days.
Every unprocessed deviation and every overdue PQR is an open risk in your system, and a defective product costs more than the quality work that would have prevented it.
The question that matters
The work. Deviations, CAPA, change control and Product Quality Reviews are actually processed by us, in your system and according to your SOPs, not as advice on how it could be done. Final approval remains with your QM management, unless you have us fill that role as well through our interim management service. This gives you additional capacity without blurring responsibilities, and your team gets breathing room back for what only they can do internally.
A quality management system relies on several tools that, together, ensure and continually improve the quality of your products. Effective, continuous quality assurance lowers quality-related costs, because expenses caused by defective products are avoided. This only succeeds, however, if the tools are established at every level and actually applied. This is precisely where things most often fall behind in day-to-day business.
Process
4 Steps, a fixed contact person, no surprises.
Arrange an initial consultationWhat is outstanding, how old, what carries the highest priority. Where it hurts most.
First the genuine risks, then the finer points.
We work according to your SOPs and your tools, so nothing is maintained twice.
Either handed back to your team, cleanly documented, or we keep the area running on an ongoing basis.
Typical initial situations
The annual product quality review is overdue, in some cases for several products. This is the first item checked in an audit.
Open cases keep getting older instead of being closed. Each one is a documented risk within your own system.
Someone has left and ongoing processes do not wait for a replacement to be hired.
The plan exists, but no one has the time. Self-inspections not carried out are a recurring audit finding.
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
Qualified Person (QP) under § 14 AMG
Key areas
Licence to practise as a pharmacist, doctorate in pharmaceutical analytics, specialist pharmacist for pharmaceutical analytics
GMP Consulting and Training
Key areas
Licence to practise as a pharmacist
Risk Assessment and GMP Documentation
Key areas
B.Sc. Pharmaceutical Chemistry, M.Sc. Biomedical Informatics, specialisation in strategic corporate management
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
Quality Management and Sterile Manufacturing
Key areas
Degree in pharmacy, licence to practise as a pharmacist, pharmaceutical technical assistant
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.
Large 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 studyWe clarify your questions in the initial consultation. Dr. Olaf Mundszinger takes the time for it.
Arrange an initial consultationBoth. You can book individual building blocks, for example only the annual Product Quality Review, only supplier qualification, or only self-inspections, or outsource your entire operational QM function on an ongoing basis. In the scoping conversation, we clarify which arrangement fits your needs and capacity.
As a rule, we work within your system, so that records, documentation and responsibilities stay where they belong. We adapt to your SOPs and your document control system. Where you do not yet have a suitable system, we support you in building one.
For most operational QM work, PQR, deviations, CAPA, self-inspections, supplier qualification, a dedicated Qualified Person is not strictly required; we provide these services independently. Where your quality system requires involvement of the Qualified Person under § 14 AMG, we coordinate with your QP or provide this role from our organisation.
After a brief scoping conversation, we typically prepare a concrete proposal with a timeline and a named point of contact within a few days. For acute backlogs, for example open deviations with deadlines or an overdue PQR, we prioritise the start accordingly, so that nothing remains unprocessed.
Where demand fluctuates, positions are vacant, or individual tasks are particularly time-consuming, usually yes. You get experienced QM specialists exactly when you need them, without maintaining permanent full-time positions. In addition, effective QM assurance lowers costs, because defective products are avoided. Where volume is consistently high, your own personnel may be more sensible, and we assess that honestly with you in conversation.
Overall responsibility for your quality system remains with you and your management, as required by pharmaceutical law. Unlike with a staffing agency, however, you receive from us a named, professionally experienced point of contact who can also draw on the expertise of our entire organisation. For specialist questions, our full team stands behind them. Responsibilities and interfaces are set out clearly in the contract.
Services that are often used together
Call us or write three lines. You will reach someone directly who can assess your subject professionally.
As a member of the Life Science Nord cluster, we benefit from a strong, innovative network and work with other experts in the industry on forward-looking developments.
