SGS Life Science Services is proud to exclusively sponsor Pharmaceutical Technology Magazine’s Webinar Series – ‘What’s New in Pharmaceutical Testing Requirements’.
The pharmaceutical analytical-testing sector has experienced significant change over the last few years, largely as a result of global contamination and economically motivated adulteration. Industry and regulators have moved quickly to update standards, guidelines, and monographs to help prevent future drug-product safety breaches. In a special webinar series, hear from industry and regulatory experts on the latest international requirements for testing for heavy metals, extractables and leachables, and contaminants.
The live events, aired June 14 to July 1, 2010, are now available for On Demand viewing. Simply click on the topics below, register and view.
This webinar highlights the changes affecting industry in the area of heavy metals testing, including a look at the latest US Pharmacopeial revisions (<231> Heavy Metals) and replacement chapters (<232> Elemental Impurities –Limits; <233> Elemental Impurities –Procedures; <2332> Contaminants in Dietary Supplements) as well as differences in impurity testing between the global pharmaceopeias USP, JP, and Ph.Eur. View the Heavy Metals webinar.
Extractables and Leachables
Monomers and additives such as antioxidants, plasticizers, and stabilizers may potentially migrate into medicinal products and should be evaluated as required by regulatory authorities. Processing equipment as well as primary and secondary container materials must be considered. This webinar highlights the changes affecting industry in the area of extractables and leachables testing, including an in-depth look at PQRI thresholds and the implementation of ICH Q4B and global pharmacopeial differences between USP, JP, and Ph.Eur. requirements. View the Extractables and Leachables webinar.
Melamine Contamination Challenges
After a series of recent contamination crises around the world, it is more important than ever to test pharmaceutical excipients for melamine adulteration, particularly those with nitrogenous composition. Granular melamine was found to have been intentionally added to product formulations, including infant formula, in order to pass protein tests by indicating a higher level of protein than actually existed in the products. Regulatory authorities have acted quickly to change testing requirements for melamine. This webinar highlights the changes affecting industry, including recent FDA guidance, USP monographs, and international harmonization efforts to standardize testing. View the Melamine Contamination Challenges webinar.
For more information, please contact:
Global Marketing Director
Life Science Services
75 Passaic Avenue,
Fairfield, NJ 07004, USA
t: +1 (973) 276 8463
The SGS Group is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With 59,000 employees, SGS operates a network of over 1,000 offices and laboratories around the world.