PV & the Building Commissioning Annual Conference

The Building Commissioning Annual Conference is a premiere event chock full of training, memorable speakers and presentations, and a chance to connect with prominent building industry professionals!

Neil Enlow

Join Certified Commissioning Professional Neil Enlow at the BCxA Annual Conference in Schaumburg, IL from September 25-27.… more


Validation of Storage Conditions

In the September 4th edition of Device Daily, it was reported that the FDA cited Dharma Research, for failing to validate the storage conditions for its Etchant gel.

Don’t let this happen to you.

Performance Validation (PV) has completed hundreds of mappings including Sub-freezers/cryogenic storage, USP Freezers, USP cold storage or chill rooms, and distribution warehouses. … more


Airline Cargo Facilities – Temperature Controlled Storage

The Challenge

A large international airline company needed to have temperature controlled storage at two major U.S. airports for the transport and short-term storage of Time and Temperature Sensitive Products (TTSPs).  As part of IATA’s (International Air Transport Association’s) certification process, a temperature mapping is required of all temperature controlled storage areas to be used for this purpose. … more


July 10 FDA Warning Letter Review

July 10 FDA Warning Letter Review

This past week two warning letters to 503B outsourcing facilities were posted to the FDA website.

In one of the warning letters, the outsourcing facility compounded drugs using raw material not on the 503B bulks list, failed to include all drugs compounded in the prior 6-months, and failed to report an adverse event within the required time period.… more


Supplier CofA’s – Do I need to do anything??

A common observation during FDA inspections is a failure of the drug company to perform incoming testing of raw materials and relying solely upon the suppliers CofA.  A common misconception is that I can simply accept the CofA from my supplier with no testing or qualification of the supplier.… more


Compounding Pharmacy Recalls

Recent Compounding Pharmacy Recalls –

Premier Pharmacy Labs is voluntarily recalling all unexpired products, intended to be sterile, due to a lack of sterility assurance. The Unexpired Sterile Drug Product Lots (include dates dispensed) are being recalled due to concerns presented during the latest FDA inspection including insufficient environmental controls, potential cross contamination and lack of product specific process validations. … more


Repeated Failures

What happens when a FDA regulated company has repeated failures during inspection or when promised corrective action does not appear to be effective?

In a recent warning letter, FDA identified four citations:

  1. Releasing products to the US market without conducting finished product quality testing.
more

New EMA Guideline

EMA released the Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container on 6 March 2019, and it will go into effect 1 October 2019.

The guideline is available here.
This document addresses:
4. General requirements
 4.1.
more

Pharmakon – Trial set

In a previous blog post I shared the current information on Pharmakon, an Indiana 503B Outsourcing Facility that released sub/super potent drugs. This facility closed in 2016 after the third FDA investigation which was prompted by an adverse event report concerning the administration of superpotent morphine sulfate (2,460 times potency) to three infants.… more


Starting Materials

Starting Materials for Drug Products:

Analysis of 108 FDA Form 483’s issued to Compounding pharmacies in 2018 was performed. A textual analysis for the term non-pharmaceutical identified approximately 11% of the facilities (12) received an observation associated with the use of non-pharmaceutical products as an ingredient (starting materials) and 1 case where a non-pharmaceutical cleaning solution was used for washing glassware.… more