Regulations

38 Results

Cleanroom and Isolator Instrumentation: Best Practices

Cleanroom and Isolator Instrumentation: Best Practices

Merck KGaA, Darmstadt, Germany | Recorded the 08-Dec-2016 | Webinar

Choosing and implementing your environmental monitoring instruments is critical for a safe production & continued compliance. Ensure optimum performance...

FDA Focus̶ Product Design and Post Approval Changes

FDA Focus̶ Product Design and Post Approval Changes

Colorcon Inc. | 19-Sep-2016 | Technical / White Paper

Review a new Colorcon Technical Paper offering a summary of key points presented in the recent US Center for Drug Evaluation and Research (CDER) Guidance...

SGS-LSS

Amino Acid Analysis of Pharmaceutical Products

SGS Life Science Services | 11-Jul-2016 | Technical / White Paper

Amino Acid Analysis in general can be used for identification testing of biopharmaceutical active ingredients and the determination of impurities and related...

Article on Viral Clearance for Biopharmaceuticals

Article on Viral Clearance for Biopharmaceuticals

Catalent Pharma Solutions | 24-Aug-2015 | Technical / White Paper

Viral clearance studies are mandated prior to entering clinical trials and for commercial launch of biopharmaceuticals.  These studies are a key component...

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