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. 

2017 Temp Mapping Summary

2017 Temp Mapping Summary

During 2017, Performance Validation executed 31 projects that included a temperature mapping component of project work.  These projects were completed with multiple clients, across both Pharmaceutical and Medical Device life science industries.  These projects included mapping studies using PV’s own inventory of Vaisala Veriteq data loggers measuring temperature only, or temperature and humidity, or using the Kaye Validator 2000 for projects involving extreme cold or heat.  more

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

Building Management System

The Challenge

A leading pharmaceutical packaging company planned to migrate their outdated Building Management System hardware which controlled and monitored their freezers, coolers and packaging suites to their existing BMS system. The monitored temperature controlled spaces contained product during the migration. … more

PDA Midwest March 2018 Dinner Meeting

PDA Midwest March 2018 Dinner Meeting

(Indianapolis, Indiana, February 2018) Performance Validation will be attending and exhibiting at the PDA Midwest March 2018 Dinner Meeting.  At this meeting there will be a networking opportunity for the attendees and vendors.  Stephanie Ranck will be presenting Comparability Protocols, and Linda Biava will be presenting Regulatory Submissions and Changes.… 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

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