As the first step in your professional life, your first job after college may impact the opportunities available to you for your entire career. In this blog post, we will discuss why your first job after college matters. It’s a learning experience. Your first job is an opportunity to learn more about the industry, gain valuable […]
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Pharmaceutical manufacturing is a highly regulated industry that requires strict adherence to quality and regulatory requirements. However, staffing shortages or a backlog of projects can put companies at risk of non-compliance and costly delays. In such cases, staff augmentation services can provide an effective solution for pharmaceutical manufacturers to meet their CSV needs. In this […]
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Performance Validation (PV) is pleased to welcome Scott Council as the new Division Director for PV’s North Carolina Hub. Scott’s extensive engineering background, combined with his experience in manufacturing and FDA-regulated environments, make him the perfect fit to lead PV’s operations in North Carolina. As a North Carolina native and North Carolina State University graduate, […]
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In Food and Drug Administration (FDA) regulated industries, computer systems and software play a critical role in managing data, controlling processes, and ensuring compliance with regulatory requirements. To ensure the safety, efficiency, and quality of pharmaceutical products, the FDA has established specific regulations and guidance documents that outline the requirements for computer system validation (CSV) […]
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Enterprise Resource Planning (ERP) validation is a critical step for FDA-regulated industries, to ensure compliance with regulatory requirements and industry standards. This process ensures that the ERP system accurately and consistently tracks and records critical data, such as product information and manufacturing processes. In this blog post, we will discuss why it is necessary to […]
Read MoreIn early 2019, the Washington State Legislature passed HB-1257, the Washington Clean Buildings Performance Standard, into law. The legislature requires that the majority of facilities greater than 50,000 gross square feet will need to meet or exceed a prescriptive energy usage target based on the type of facility, with the largest buildings needing to comply […]
Read MoreSeptember 2016, I blogged about the draft FDA Guidance Facility Definition Under Section 503B of the FD&C act. In May 2018, the draft guiance was approved and published in the Federal Register and is available here. Industry Questions: FDA has been asked whether an outsourcing facility can create a separate area within its facility for compounding according to […]
Read MoreThis year’s theme for the ISPE 2018 Annual Meeting and EXPO is Vision to Reality: Delivering Next Generation Therapies. One of the frequent challenges when delivering next generation therapies is available manufacturing space. Either the existing facility is committed to current products with no excess capacity, or the time/cost to reconfigure the existing facility to meet […]
Read MoreIn a recently posted FDA Warning Letter, USFDA provided a clear expectation concerning the purpose of validation: The purpose of validation is to determine whether your processes can operate within established parameters to assure consistent batch uniformity, integrity, and drug quality. Reliable and well-documented batch operations are essential to ensuring process control and drug quality. The firm […]
Read MoreWhat are the top 5 citations from FDA inspections for the past 3-years (2018-2020)? #1 For each of the past 3-years 21 CFR 211.22(D) has been the most frequent observations in FDA inspections. The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed. According to […]
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