Good manufacturing practice (GMP) support
Consultant support as Acting Qualified Person (QP)
We can offer a dependable solution to ensure compliant product release.
We can offer a dependable solution to ensure compliant product release.
If you hold a manufacturing licence (including GMP certificate, Manufacturing and Importation Authorisation), legislation will require you to register at least one Qualified Person (QP) with the competent authority.
The responsibility of the Qualified Person is to assure that the good manufacturing practice standards are fulfilled and that the provisions described in the Marketing Authorisation are met.
The QP is legally responsible for any batch that he or she has certified.
To be considered for that position, they must have detailed knowledge of the steps that are included in your manufacturing process. In case of need the QP should be able to prove their continuous training regarding the product type, production processes, technical advances, and changes to GMP.
The QP performs:
Batch certification, meaning that the manufactured batch is safe in terms of quality, efficacy, and safety to be released for sale and distribution into the market.
Release of an investigational medicinal product for use in a clinical trial.
Local release of any pharmaceutical product that is imported from a third country.
Approval of an API (active pharmaceutical ingredient) used in manufacturing for specific pharmaceutical products must also be approved via a QP-declaration.
If you are relatively small, you might not find it feasible to employ a full-time QP.
Given the specific competence required, it may also be a challenge to find the right person to employ.
Our experts not only fulfill the legal requirements for acting QP, but also have a profound knowledge in quality assurance and are able to support the company QA manager.
We can offer QP support either as an interim solution, on a continuous basis or as back-up for the company employed QP.
Our experts can also assist with assessment of API-manufacturers for the statement of a QP declaration (Auditing), or the appropriate GMP-compliance for excipients and their suppliers.
Auditing
Commercial production support and advice
GMP responsibilities for MA holders
Quality assurance and GMP compliance
Quality control and batch evaluation
Technology transfer support and advice
Erik Hedner
Arex Advisor AB
Contact us
Staffan Thunell
Founding partner
BSc Economics and BA
Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from positions as Founder, Chairman, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.