Good manufacturing practice (GMP) support

Quality control and batch evaluation

Our experts support with QC and analytical methods to:

  • assure product quality when it comes to raw materials, components and finished product
  • enable a timely product release
  • facilitate the investigation of out of specification (OOS) and out of trend (OOT) values
  • minimise the risk for deviations, a very important component in a potential product recall situation
  • add value for the registration process
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About quality control

As described in EudraLex, Quality Control is the testing of ingoing materials and the final product according to approved and validated methods. It is your way to ensure that no batch is released for use before it has been shown to comply with the determined and approved specifications.

This is a resource-consuming activity which benefits from a clear definition of the standard you strive to achieve.

 

Why use our support with quality control?

Arex Advisor’s consultants have extensive experience with analytical chemistry combined with a deep understanding of regulatory and technical requirements.

We are familiar with analytical challenges that you may encounter during development, scale-up or production of a pharmaceutical product and can help with:

  • Advice on choice of analytical method and validity checking
  • Setting up ICH-stability protocols and in-use protocols
  • Review of SOPs for analytical methods
  • Checking and ensuring technical and regulatory compliance
  • Providing long-term support to your QC Analytics team when you have resource gaps

More good manufacturing practice (GMP) support services

Acting Qualified Person (QP)
Auditing
Commercial production support and advice
GMP responsibilities for MA holders
Quality assurance and GMP compliance
Technology transfer support and advice

Your contact person
Portrait of Nelly Fransen Arex Advisor

Nelly Fransén

www.arexadvisor.com

Arex Advisor AB

  • Sveavägen 9,
  • 111 57 Stockholm
  • Sweden

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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.