EAS Publishes Article on Packaging Challenges for FDA Industries in Tablets and Capsules
EAS Independent Consultant and expert in packaging solutions for FDA industries, Jim Goldman, wrote an article on quality considerations and mitigations of supplier and customer challenges that was published in Tablets and Capsules. EAS experts such as Jim help...
What are the Requirements for a Successful DMF Submission for an Active API?
EAS independent consultant, Radhika Rajagopalan answers your questions on DMF submissions in Tablets and Capsules magazine. Under the Generic Drug User Fees Act (GDUFA), the FDA applies a holistic, life-cycle approach to the evaluation of active pharmaceutical...
Pharmaceutical GMPs, Quality Control, and Data: A Deeper Look at FDA’s FY 2020 FDA Observations
By Amy Scanlin Reprinted with permission from FDLI Update Good Manufacturing Practices—those minimum requirements for methods, facilities, and controls used in manufacturing, processing, and packing of drug products.1 Though clearly articulated by FDA, a review of FY...
GMPs for Combination Drug-Device Products – Understanding Compliance Requirements for Each Component
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...
Good Manufacturing Practices – Comprehensive Equipment and Utility Change Control for GMP Production Facilities
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 …