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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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How Commissioning Shapes the Built Environment
Over the past few years, the focus in the construction and design, especially in the K-12 world, has shifted to thinking about the built environment. Simply put, the built environment considers and encompasses more about a space – it includes what the space is used for, who the space is used by, and how we […]
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White House Announces Firmer Stance on Energy Efficiency in Commercial Buildings
On January 21, 2022, the White House announced it is partnering with states and communities to evaluate, improve, and manage building performance standards across the country. Their goal is to take a more uniform approach at the federal level to reduce emissions from commercial and government buildings. Here in the Pacific Northwest – both the […]
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Washington Clean Buildings Performance Standard Consulting – Now Offered by PV
Performance Validation is excited to announce we will be offering consulting services to help clients across Washington bring their facility portfolios into compliance with the new Clean Buildings Performance Standard (HB1257). HB1257 is a recently adopted legislative measure that requires existing commercial buildings over 50,000 square feet to meet or exceed energy benchmarks as defined […]
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