Five Things

Five things a Pharmacist should understand prior to writing that check for registration fees to the FDA for their brand new 503B outsourcing facility.

  1. These facilities are inspected by USFDA following the applicable FDA Compliance Policy Guide 7356.002 Drug Manufacturing Inspections and 7356.002A Sterile Drug Process Inspections. 

Center of Excellence on Compounding

As reported by Zachary Brennan (Feb 14, 2018), FDA Commissionner Gottlieb outlined FDA plans for FY 2019. Of specific interest to the Compounding world: FDA is proposing to create, as it did for oncology, a “Center of Excellence on Compounding for Outsourcing Facilities,” with expanded FDA engagement with outsourcing facilities and states to help the pharmacy outsourcing industry grow to meet its intended function and adhere to higher quality standards to protect patient health.… more

Phillips Medical Systems

USFDA inspected Phillips Medical Systems 7-17 to 8-18, 2017 and on completion of the inspection issued Phillips Medical Systems an 18 page 483 with 9 observations.

If I were a patient and had to get re-scanned/re-injected because of a known equipment failure (page 3, b1) , I would be a bit upset.… more

PDA Midwest Dinner Meeting

Performance Validation sponsored and exhibited at the PDA Midwest Dinner Meeting. In attendance from PV were Mike Stires and Gerry Achoki.

The speaker for this event was Tony Cundell, Ph.D. who presented on Current Activities of the USP General Chapters – Microbiology Expert Committee.… more

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