Jan 1, 2021 | Drugs, EAS in the News Drugs, EAS in the News Medical Device, Extra Article, Medical Devices
EAS published an article in MedTech Intelligence on the importance of component GMP requirements for drug-device combination products. “The rapid development of combination products—biologics, pharmaceuticals and their devices—provides great opportunity for...
Jun 1, 2020 | Drugs, EAS in Action, EAS in the News Drugs
Many companies limit change control to documentation, such as batch records, SOPs, protocols and specifications, while handling equipment and change control in isolation. As a result, new equipment is often installed and connected to utilities without input from facilities, engineering, validation and …
Jun 1, 2020 | Drugs, EAS in Action, EAS in the News Drugs
The US Food and Drug Administration (FDA) is responsible for advancing the public health by helping to speed innovations that make medicines safer and more effective and by helping the public get the accurate, science-based information it needs to use medicines to...
Jan 22, 2020 | Drugs, EAS in the News Drugs
Tablets and Capsules January 22, 2020 Comprehensive equipment and utility change control for GMP production facilities Greg...
Jul 22, 2019 | Drugs, EAS in the News Drugs
ISPE iSpeak blog July 22, 2019 https://ispe.org/pharmaceutical-engineering/ispeak/fda-office-regulatory-affairs-historical-look-and-evolving-future Joel Martinez
May 30, 2019 | Drugs, EAS in the News Drugs
ISPE iSpeak blog May 30, 2019 https://ispe.org/pharmaceutical-engineering/ispeak/common-pitfalls-during-implementation-cleaning-validation-program Miguel Montalvo
