Services · Strategic GxP Consulting & QA Support
An unvalidated process, unqualified equipment, a QM system with gaps, and no resources to address them. A&O Pharma provides you with an experienced consultant who sets up your QM system, validates processes, qualifies premises and equipment from DQ to PQ, and implements QM processes in line with GMP, for predictable costs and consistent product quality.
Non-binding and confidential. Answer in one to two working days.
As long as the method and process are not validated, and premises and equipment are not qualified, your facility produces stock rather than released goods, and your business stalls.
The question that matters
Only in the rarest cases does everything need to be redone. What matters is not the scope but a sound, practice-oriented risk-based assessment, to ensure productivity and quality following a change. We assess what has actually changed and what it affects, and derive from that what must be validated, what must be requalified and how it must be documented. This generally saves considerably more effort than the assessment itself costs, and gives you the assurance of continuing to produce reliably.
Validated methods and processes as well as qualified machinery and equipment are essential prerequisites for the reliable, error-free manufacture of your products. They allow you to ensure consistent quality with predictable costs. Poor product quality, by contrast, leads to high, unpredictable expenditure. Sound validation and qualification therefore pay off both for the patient and for you as the manufacturer.
Process
4 Steps, a fixed contact person, no surprises.
Arrange an initial consultationWhat exists, what are your goals, what is missing. Usually more is already in place than expected, just not documented.
Together we determine what needs to be created, validated and qualified, how and in what order.
Creating/revising the quality system, process and method validation, qualification from DQ to PQ, process validation. On request, also with analytics from our laboratory.
You receive a quality system and reports that withstand scrutiny. On request, we are present during the inspection.
Typical initial situations
A new site, new product or new equipment, and the authority has announced its visit. You need someone who knows what will be scrutinised.
An audit has uncovered gaps and the response needs to be robust, not just fast. An inadequate response only generates the next finding.
A process is moving to another line or another plant. Without clean transfer and process validation, batch release is at risk.
You are growing, or for the first time need a system that is more than a collection of files.
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.
Business Development
Key areas
Training as a bank clerk, degree in pharmacy, licence to practise as a pharmacist, Master of Business Administration (MBA)
Founder and Managing Director
Key areas
Doctorate in analytical chemistry, degree in pharmaceutical sciences and chemistry
Risk Assessment and GMP Documentation
Key areas
B.Sc. Pharmaceutical Chemistry, M.Sc. Biomedical Informatics, specialisation in strategic corporate management
Development Analytics
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
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
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 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 studyMid-sized company, marketing authorisation holder
Review of the marketing authorisation chapters and quality documents, risk assessments and a robust transfer plan for the planned change of manufactur...
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. Sascha Manthei takes the time for it.
Arrange an initial consultationBoth. You can commission a specific module, such as just carrying out an audit, the qualification of premises or a new piece of equipment, or support for an upcoming inspection, or the entire spectrum from setting up the QM system through validation and qualification to the inspection as a complete package. We start wherever you currently feel the greatest pressure.
Responsibility lies with a named, knowledgeable and experienced consultant who is directly reachable by you. You do not speak to an anonymous ticketing system but to the person accountable for your project. That is the core of our model: personal consulting and continuity rather than changing points of contact.
We start with a risk analysis and then support you through all four qualification stages: Design Qualification (DQ) for specification and selection, Installation Qualification (IQ) for correct installation, Operational Qualification (OQ) to demonstrate specified function, and Performance Qualification (PQ) to demonstrate reproducible performance in routine operation. Equipment and premises are covered equally, each traceably documented for reliable production.
We first gain a complete overview of your QM system and close the gaps identified in a risk-based, structured manner. We accompany you on-site during the inspection, and afterwards we support you in addressing findings and defining corrective and preventive actions. How much can be achieved in the remaining time depends on the starting position, which we assess openly in the first, non-binding discussion.
No. We carry out analytical method validation, from method development through the validation plan and execution to the validation report, in our GMP-compliant, fully digitalised laboratory. This model is therefore also suitable for companies without their own analytics, including virtual pharma companies.
We plan the product transfer in a structured manner, carry out the process validation at the receiving site, and document the outcome in a process validation report in accordance with GMP. This demonstrates that the transferred process reproducibly delivers products of the required quality, forming the basis for subsequent routine operation and batch release.
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.
