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April 2018 (week of 4/23/18) three cGMP warning letters were posted by FDA. The most interesting warning letter was to a Chinese API manufacturer for an inspection from October 2017 and provides some interesting lessons learned. This API manufacturer promised FDA to improve controls over laboratory computerized systems to prevent unauthorized access or changes to data (data integrity) […]
Read MoreAmerican Society for Quality Certifications
Indianapolis, IN (June 7, 2013) Performance Validation, a nationwide leader in providing validation, commissioning, and quality services, today announced that Kristin Beckman successfully obtained certification as ASQ Certified Quality Auditor (CQA), and Evelyn Chrivia and Julie Hart successfully obtained certification as a Certified Quality Improvement Associate (CQIA). ASQ’s Certified Quality Auditor is a professional who […]
Read MoreAlex Whittaker – Certified Quality Auditor
For Immediate Release (Indianapolis, Indiana; July 21, 2017). Performance Validation is pleased to announce that Ms. Alex Whittaker has successfully completed certification as a Certified Quality Auditor. Alex is a Validation Specialist with Performance Validation and is responsible to assist in the implementation, monitoring, and continuous improvement of our Quality Management System at a divisional […]
Read More503B – Pre-registration Consulting
The Challenge A pharmacist seeking to build a new 503B Outsourcing Facility requested assistance in the understanding and implementation of current good manufacturing practices (cGMPs) and the FDA risk based inspection processes. Background: In 2012, the CDC and USFDA investigated a multistate outbreak of fungal meningitis and other infections among patients who received contaminated preservative-free […]
Read More503B Electronic Record Data Integrity
For compounding pharmacies regulated under section 503B, electronic record data integrity concerns are increasing in regulatory and customer visibility. The concepts of good data integrity practices is not new. Yet an organization can inadvertently open itself up to serious problems with their electronic record integrity if proper operating and computer system validation procedures are not […]
Read More503B Data Integrity Concerns
For compounding pharmacies regulated under section 503B, electronic record data integrity concerns are increasing in regulatory and customer visibility. The concepts of good data integrity practices is not new. Yet an organization can inadvertently open itself up to serious problems with their electronic record integrity if proper operating and computer system validation procedures are not […]
Read More21 CFR 211.42 – Buildings and Facilities
A review of FDA citations for 21 CFR 211.42 Subpart C Buildings and Facilities over the past 5 years (2018-2014) from the FDA Turbo data was conducted by Performance Validation. Our analysis identified that the highest frequency of citations within the buildings and facilities subpart were consistently attributed to two code sections: The citations to these two sections are […]
Read More21 CFR 211.192 Production Record Review
“The USP has established that the acceptable range of most compounded preparations is typically ±10%; however, it can be as great as ±20% (as with some proteins) or as tight as ±5% (as with potent analgesics). For some raw powders, potency is required to be within ±2%”, (Kupiec, 2005, p. 136; Rooney & Heuvel, 2004). […]
Read MoreData Integrity Warning Letter Summary – August 2018
The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter to a Japanese bio-chemical manufacturing company. The Warning Letter summarized significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). The letter cited non-compliance with section 501(a)(2)(B) of the 21 U.S.C. 351(a)(2)(B). The FDA inspection observed many data integrity non-compliances included retesting and manipulation […]
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The Relationship Between Sustainability and Commissioning
Before the green building movement got much traction, and before it was required by many of the energy codes and sustainability programs that we work with today. On this Earth Day, we want to talk about the role that commissioning has in sustainability, and why investing in sustainability is something we should all get behind. […]
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