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QA/QC

 

Endotoxin definition and standardisation

20 May 2019 | By

Appropriate standards for impurity tests are an important part of analytical testing. In this paper, Kevin Williams outlines various requirements of standards for endotoxin, as stated by United States Pharmacopeia (USP), and elaborates on the definition of endotoxin as distinct from other cellular constituents.

Nelson Labs: supporting internal quality processes

14 May 2019 | By

Nelson Labs has a long history of partnering with pharmaceutical and biopharmaceutical companies. We perform a variety of testing to support your internal quality processes including: sterility (USP 71) testing in a cleanroom for isolator environment, particulates testing (USP 787, 788) using a variety of methods, bacterial endotoxin, filter validations,…

Eurofins BioPharma Product Testing

10 May 2019 | By

From starting materials through to finished product testing, Eurofins BioPharma Product Testing’s 34 facilities in 17 countries deliver a comprehensive scope of harmonised GMP testing services and seamless regulatory acceptance.

Charles River microbial solutions

8 May 2019 | By

Those who work in QC know that the job is more than a box to be checked, and that it can’t be done effectively without confidence in the reported results. Tight timelines, regulatory demands, and stringent data integrity standards can make it hard to focus on what’s really at stake…

Taking the difficulty out of API process filtration

26 April 2019 | By

Amazon Filters has selected the Making Pharmaceuticals Exhibition & Conference 2019 to showcase its latest filter housings and microfiltration filter cartridges, which are used in the manufacture of Active Pharmaceutical Ingredients (API) and are the essential components when creating pharmaceutical products.

European Pharmaceutical Review Issue 2 2019

25 April 2019 | By

This issue questions whether companies are sufficiently investing in regulatory intelligence software and what the potential consequences of Brexit might be for locations outside of the UK and EU. The issue also features articles on microbiology, formulation and biopharma, courtesy of our in-depth focus sections; as well as outlining the…

Don’t let difficult substances control your cleaning validation

18 April 2019 | By SUEZ

TOC analysis is a widely adopted method for detecting residual product or cleaning agents on manufacturing equipment. Compared to specific methods such as HPLC, TOC can provide better process understanding and efficiency for cleaning validation (CV), verification and continuous monitoring...

Flyer: Your drug development partner

21 March 2019 | By

Eurofins CDMO provides full range of drug development and manufacturing services from formulation screening and development, analytical development, stability studies and pre-clinical safety assessment studies to sterile and non-sterile manufacturing, IND/ IMPD and NDA/ CTD services, as well as clinical trial material including packaging and logistics.