Finished Drug Product Distribution Warehouse Commissioning

The Challenge

A large pharmaceutical company planned a new construction finished drug product distribution warehouse located in Indianapolis.  The project included controlled room temperature (CRT) storage, refrigerated storage, and freezer storage for products as well as an attached administrative office area. … more

2018 ISPE Aseptic Conference

Indianapolis, IN, February 13.  Performance Validation (PV) a nationwide leader in providing commissioning, qualification, validation, and quality services to the pharmaceutical, biotechnology, and medical device industries will be attending and exhibiting at the 2018 ISPE Aseptic Conference in Reston, VA. Interested in learning how PV has assisted other aseptic manufacturers?  … 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

USP Chapter Updates – PDA Midwest Meeting

(Indianapolis, Indiana, January 2018) Performance Validation (PV) will be attending and exhibiting at the PDA Midwest February 2018 Dinner Meeting.   At this meeting there will be a networking opportunity and Dr. Tony Cundell will be presenting information concerning USP Chapter updates. … 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

Performance Validation Becomes a 100% Employee Owned Company

INDIANAPOLISJan. 3, 2018 /PRNewswire/ — Performance Validation (PV), a nationwide leader in providing commissioning, qualification, validation, and quality services to the pharmaceutical, biotechnology, and medical device industries, is pleased to announce the company has established an Employee Stock Ownership Plan (ESOP), becoming a 100% employee owned company.… more