Good Auditing Practices, Making the Most of Your Internal Review – EAS Short Course
Regular and formal internal audits provide a clear, unbiased view of your facility operations and uncover challenges that must be addressed. No matter your FDA regulated industry, having a formal, thorough and documented audit plan will streamline your audit processes …
Maintaining Compliance through Virtual Audits
When the phone rings at EAS Consulting Group lately it is very often someone seeking assistance with Good Manufacturing Practices. While COVID-19 has caused major disruptions to global supply chains and manufacturing capabilities, FDA regulated industries forged ahead…
Ensuring Regulatory Compliance of GMP Laboratories
Compliance with Good Manufacturing Practice (GMP) requirements for Research and Development and Quality Control Laboratories cover the physical, analytical, and microbiological safety of operations and products. It is critical to ensure laboratory GMP are met …
Selecting and Submitting an ANDA Application
The FDA Generic Drug User Fees Amendment (GDUFA) has entered a relatively matured stage with applicants of Abbreviated New Drug Applications (ANDAs) experiencing a timely review and communications regarding their submissions packet, as well as increasing approval numbers. However, until an ANDA …
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 …