PV @ Midwest Society of Quality Assurance Annual Meeting – 6-7 August 2019

PV’s  Kevin Marcial will be presenting “A Practical Guide to Risk Based Computer System Validation” at the Midwest Society of Quality Assurance Annual Meeting August 6-7, 2019. Come to Indianapolis to learn about risk-based CSV and other great topics in the QA world.… 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


Kaye Validator AVS ICAL Software Validation

The Challenges

A manufacturing division of a major pharmaceutical corporation owned and operated a number of Kaye Validator thermal validation systems. Historically, the facility’s Metrology department had outsourced the scheduled calibration of the Kaye Validators and their sensor input modules (SIMs) to the vendor, which limited their control over the time it took to return the units to service.  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

IBM Clinical Development EDC Validation

The Challenge

A global organization that develops, manufactures and sells diagnostic instruments and related software needed validation for their cloud based Electronic Data Capture “EDC” platform, “IBM Clinical Development” to help reduce the time and cost of clinical trials.  Their clinical sites would enter study data into the software and it would expedite their data review and processing.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


Data Integrity Risks on SCADA Systems

SCADA (Supervisory Control and Data Acquisition) software vendors have historically served industries that require tight controls over system configurations and data records.  As a result, modern SCADA software systems have evolved to provide a robust set of tools intrinsically designed to prevent the intentional or unintentional undetectable alteration of system data.  more