Qualified Person (QP) Services
Manufacturing Authorisation holders are mandated by law to maintain a continuous presence of at least one Qualified Person (QP). It is the responsibility of the QP to certify batches of medicinal products before they are allowed for sale or use.
At Apotech, we specialise in providing in-country interim QP services for the certification of both commercial products and investigational medicinal products. Our QPs bring extensive experience across diverse biotech and pharmaceutical products, including:
- Tablets and capsules
- Liquids
- Topical
- Sterile
- Biologics
- Advanced Therapy Medicinal Products (ATMPs)
- Blow-Fill-Seal
- PET Radiopharmaceuticals
Speak directly to one of our local EU QPs.
Trusted by top-tier teams worldwide
FAQs
At Apotech, we offer full transparency on our Quality Assurance services. We aim to make the process as simple to understand as possible and are always on hand to answer any questions you might have.
Here are some of the questions we get asked most often.
Yes, we have an amazing team of consultants who work with us to perform local activities such as batch release or authoring SOPs in local languages.
As we understand each country's specificities, we can supply you with the right qualified person, according to the local regulations required.
Featured case studies
Batch Release as EU Qualified Person
Batch Release as EU Qualified Person Introduction Our client is a vertically integrated company in chemical synthesis and manufacturing of generic Active Pharmaceutical Ingredients and Drug Products. Standards and references cGMP ISO 9001 GDPR Trackwise, World Excel, power point Scope of work Remote batch certification and release of medicinal products Provide regulatory expertise as…