Quality Systems

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Articles

Harmonization of regulatory guidelines not only reduces workloads for manufacturers and regulators but can potentially help to accelerate patient access to vital therapies.

Regulatory Harmony

Instrumentation advancements over the past 30 years have certainly enabled greater efficiency in pharma development and analysis despite slow adoption by the industry.


Tooling Up for Pharma

To deal with the complex requirements of biopharmaceuticals, companies need a sophisticated toolbox of analytical and purification techniques.


Analysis and Purification: Instrumental to BioPharma

Sean Milmo is a freelance writer based in Essex, UK.

European Union regulators have taken a significant step towards resolving some of the major supply-chain difficulties behind medicine shortages.


One Small Step for Man, One Giant Leap for Pharma Regulators

Machine vision systems have been an integral part of pharma manufacturing and packaging for many years and, with the introduction of stricter safety regulations, are set to become more vital.


Farther Than the Eye Can See

Jessica Rayser is product manager, Accugenix, Microbial Solutions, at Charles River. 

Strong personnel training, detailed SOPs, commitment to data integrity, investigation and implementation of appropriate modern methods, and employing Lean and Six Sigma methodology initiatives are key best practices for the quality control microbiology lab.

Best Practices in the QC Micro Laboratory

J. Scott Mellors is principal scientist at 908 Devices Inc.

Helen Yan is senior associate scientist at Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320.

Burton Lee is senior associate scientist at Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320. 

Jiemin Bao is scientist at Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320. 

Tawnya Flick is principal scientist at Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320. 

Laura E. Blue is principal scientist at Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320.

The ZipChip CE-ESI interface was evaluated for suitability as a platform approach for quantitation of MIs in API. 

Quantitation of Mutagenic Impurities in APIs Using a Platform Chip-Based CE–MS Method

Protein characterization is a critical part of drug development, but as there are still limitations with available techniques, industry needs to look at technological advances to meet the specific requirements of complex molecule characterization.

Accepting the Challenge of Protein Characterization

Agnes Shanley is senior editor of Pharmaceutical Technology.

Senior managers of OTC drug companies are on a learning curve, as FDA warning letters cite insufficient understanding of cGMPs and inadequate responses to prior 483s.

FDA Steps Up Enforcement of cGMPs for OTC Drugs

A July article in Science suggests that FDA enforcement activities have dropped significantly during the current US presidential administration.

Quality Assurance/Quality Control