March 28, 2023 || Brian Stephens
EXECUTIVE SUMMARY In June 2017 the FDA announced that they would not enforce the Drug Supply Chain Security Act (DSCSA) until November 2018 in a move to avoid supply disruptions by providing manufacturers with additional time to implement compliant systems. The Agency still maintains the goal of complete serialization of…
March 28, 2023 || Richard Tree
Project Overview A global medical device manufacturer sought to improve Safety, Equipment Reliability, Overall Equipment Effectiveness (OEE), and cGMP regulatory compliance by performing a plant-wide reliability and best-practice benchmarking assessment. The goal: perform a thorough reliability assessment and benchmarking against industry standards, OSHA, and cGMP requirements to establish a reliability…
March 28, 2023 || R. Filannino
EXECUTIVE SUMMARY The competitive market demands rapid introduction of new GMP products. Manufacturing organizations configure their production systems to achieve the necessary agility and flexibility to rapidly develop and manufacture new GMP products at full-scale. But the market also demands reliable and inexpensive sources of existing GMP products. Many manufacturing…
March 28, 2023 || Chip Bennett
Design Review (DR) and Quality Risk Management (QRM) are considered current industry practice and are essential as enabling processes for verification of facilities, systems, and equipment. But what is Design Review? Why is Design Review underutilized in Commissioning, Qualification, and Validation projects? What are the risks of not performing Design…
March 28, 2023 || Jeff J. Gaerke P.E.
Executive Summary There has been significant debate over the years between regulatory agencies and the pharmaceutical industry regarding the advantages and disadvantages related to patient sterility risk with performing Pre-Use Post-Sterilization Integrity Testing (PUPSIT) of sterilizing-grade filters. This white paper will not add to this specific discussion; instead, the purpose…
March 28, 2023 || Rich Tree
INTRODUCTION Following any tech transfer project, the subsequent startup of the manufacturing line is almost always full of challenges. The goal is to startup as soon as possible once the project is completed but also to achieve steady state throughput as quickly as possible after the startup begins. This type…
