503A Pharmacies

503A pharmacies were mentioned 31 times in FDA Commissioner Scott Gottlieb’s testimony before U.S. House of Representatives Subcommittee on Health, Jan 30, 2018

Commissioner Gottlieb states (Examining implementation, 2018, p. 5):

For example, during our initial inspections, we have seen vermin, such as cockroaches, in the area where employees prepare for sterile processing; employees processing sterile drugs with exposed skin that sheds particles and bacteria; contamination, including bacteria and mold, in the environment where sterile drugs are produced; and much more.… more


Design Review

A Design Review (DR) is a systematic process used to review the design of facilities, utilities, and equipment against specifications. It is best to complete a Design Review early in a project so that design or specification issues can be brought to the forefront before changes become damaging to the project budget and timeline.… more


NECC Nightmare Comes to a Close

With the sentencing of Glenn Chin the supervisory pharmacist at the now closed New England Compounding center to 8-years in prison, hopefully the NECC nightmare comes to a close. Previously Barry Cadden co-owner of NECC was sentenced to 9 years in prison.… more


ASTM E55 Winter Newsletter

The ASTM E55 Committee – Manufacture of Pharmaceutical and Biopharmaceutical Products Winter 2017/2018 newsletter is available for your review at the following link.

This newsletter provides information on:
  • E55 Subcommittee Reports and progress made on developing various standards
  • The establishment of a new subcommittee on Lyophilization
  • E55’s outreach strategies
  • 2018-2019 Committee Officers
  • Welcome to our new members
Performance Validation is a member of ASTM’s E55 committee and our active members are Bryan Zylla from our Michigan office, and Rick Van Doel from our Indianapolis office. … more

Validation of Ignition SCADA (Inductive Automation) System for Medical Device Assembly

A leading medical device manufacturer introduced a new production line to their assembly facility.  The new line was designed to accommodate the simultaneous production of several makes and models of hand-held motor-driven surgical devices.  This new line was designed to apply the latest integrated manufacturing technology to optimize flexibility, efficiency, quality controls, and real-time accountability toward meeting immediate market demand for product.  … more


FDA 2018 Compounding Policy Priorities

January 2018, FDA Commissioner Scott Gottlieb issued the FDA 2018 Compounding Policy Priorities Plan on the FDA website.

This communication provides a summary background on how the FDA became involved in compounding pharmacies, and a summary of how FDA will prioritize actions to protect the public health as obligated under DQSA.… more

User Requirements

User Requirements

User requirements are just what the name implies.  They are requirements set by the end user.  These requirements express how a facility, equipment or process should perform in terms of the product to be manufactured, required throughput, and conditions in which product should be made. … more


Quality Risk Management

Why are we concerned with Quality Risk Management (QRM) when planning, developing, and executing commissioning, qualification, and validation work?  

The simple answer is time and money.  Pharmaceutical companies are under pressure to bring new therapies to market quicker and to do so at less cost, while still meeting the mandates of cGMPs which ensure the Safety, Integrity, Strength, Purity and Quality of the manufactured medicine.  more


2017 FY FDA Inspection Summary

The 2017 FY FDA inspection summary has been published to the FDA website.  you may download the FY 2017 Excel File from the following link.  This file contains a summary of FDA Form 483 data for inspections ending between 10/1/2016 and 9/30/2017 and is a great tool to evaluate the various citations observed from various FDA inspections. … more


AI and Drug Development

Recent research published by the University of Warwick (2017), describes a new algorithm that can predict the interactions between a protein and a drug molecule based on a limited number of actual experiments (AI and drug development).  The algorithm can predict with a 99% accuracy if a drug molecule will bind to a target protein.… more