The goal is to have a system that’s fit for purpose – enough but not too much – in Swedish this is referred to as “lagom”.
A good system will give you a set of interacting elements that detail the structure of the organisation to ensure constant quality of products and/or service.
You will be in a position to show inspectors and suppliers/customers that you are a trustworthy partner.
According to the EU GDP (Good Distribution Practice)-2013 you need to have a Quality Management System (QMS) when you are involved in the distribution of medicinal products.
The QMS describes procedures for managing activities, resources, contracts, risks, training and other processes.
Furthermore, you need Standard Operating Procedures (SOPs) describing important processes such as distribution, risk management, deviations and audits, as well as training of your staff.
Even though the law describes what you need to consider when setting up your QMS, every system is unique. For example, if you are a distributor buying and selling medicines you have different responsibilities and activities compared to a Marketing Authorisation Holder (MAH).
Arex Advisor can help you adapt the system to your needs and to be compliant to regulations.
Acting Responsible Person (RP), including 24/7 coverage
Auditing
Evaluation/structuring of distribution system
WDA application management, including inspection support
Input to quality agreements
Management of product quality complaints
Lovisa Rosenquist
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.