By engaging our experts you can save time and add resources to your already competent group for a specific assignement in quality assurance.
We can also help you investigate if there is potential to improve the system, leading to saved resources further on.
In addition, we support your preparation for an upcoming audit or inspection from a customer or from the competent authority.
Quality cannot, and must not, be added at the end; it must be built into the system from the start. That is the only way to ensure that requirements be ascertained, mistakes avoided, and processes performed efficiently with minimum resource.
Maintaining your GMP helps you deliver safe and accurate pharmaceuticals.
The pharmaceutical GMP principles are mainly the same globally with minor differences between, for example, the EU, US and Japan.
Here are the basic things to know about Good Manufacturing Practice:
It is a regulatory framework that governs the manufacturing within the pharmaceutical industry.
It describes the minimum quality standard that a manufacturer of marketed pharmaceuticals or clinical trial materials must meet.
There are 10 basic principles of GMP, but these can be simplified into documentation and control.
When you work with GMP you must be able to prove and show who did what, when and how. You will work according to determined and documented procedures, and all deviations must be documented, assessed, and resolved.
Arex Advisor can help you build an efficient quality system:
– We evaluate current systems and processes to find potential gaps.
– We identify possibilities for simplifications and improvements.
– We help avoid deviations and time-consuming detours by setting you up on the documented way from the start.
Acting Qualified Person (QP)
Auditing
Commercial production support and advice
GMP responsibilities for MA holders
Quality control and batch evaluation
Technology transfer support and advice
Nelly Fransén
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.
