Skip to main content
Over the past few years, I have read hundreds of FDA warning letters. A common observation that I wanted to share was the apparent difference in perceptions between the inspected organization and the FDA. My opinion is that in most cases, the inspected organization takes the FDA findings for this instance in time and often […]
Read MoreTesting and Risk-Based Computer System Validation
Performance Validation recently featured an introductory post on risk-based computer system validation. It is an approach by which one can focus the validation effort on critical business and regulatory requirements and reduce the need for excessive testing and redundancy. A fundamental aspect of this approach is to leverage software vendor functional testing. This permits the […]
Read MoreTemperature Mapping and WHO
There are a number of industry regulations from all around the world that explicitly and implicitly require temperature mapping as a documented process to demonstrate adequate temperature conditions are maintained for storage of temperature-sensitive pharmaceutical products. However, most of those regulations provide little guidance as to the specifics on how an appropriate temperature mapping should […]
Read MoreSupplier Qualification
In a recently posted warning letter, a drug manufacturer was cited for receipt and delivery of adulterated drugs. As cited in the warning letter: We note that an inspection of records at your facility and a review of FDA import data demonstrated that FDA has, in the past, taken regulatory action against at least 23 of your […]
Read MoreSupplier 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. This is not acceptable per the […]
Read MoreStephanie Welte – Receives ASQ Certified Quality Auditor Certification
For Immediate Release (Indianapolis, Indiana; June 16, 2014). Performance Validation is pleased to announce that Ms. Stephanie Welte has successfully completed certification as a Certified Quality Auditor. The Certified Quality Auditor is a professional who understands the standards and principles of auditing and the auditing techniques of examining, questioning, evaluating and reporting to determine a […]
Read MoreStephanie Welte Promoted to Principal Validation Engineer
Indianapolis, IN (August 2015) Performance Validation, a nationwide leader in providing validation, commissioning, and quality services, today announced the promotion of Stephanie Welte to Principal Validation Engineer. The Principal Validation Engineer advises clients on best industry practices; defines, plans and executes project work including research, evaluation, and/or solution development to achieve customer objectives; and lead project related functions […]
Read MoreStarting 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 […]
Read MoreSoftware as a Medical Device (SaMD): Clinical Evaluation and Validation
So you have a Fitbit or activity tracker? How is it going – is it helping motivate you to move more, perhaps monitoring your heart rate? That is great – but is your doctor using the data to make decisions about your health? Probably not. However, this is the kind of question we begin to […]
Read MoreSmoke Studies
A review of the Form 483’s issued to the 45-registered and inspected 503B Outsourcing Facilities identifies that over 40% (n = 19) of the inspected facilities received one or more observations concerning inadequate smoke studies. Common findings of the smoke studies included studies that were not performed under dynamic conditions, studies that do not adequately reflect […]
Read More