Manufacturing drug products aseptically requires the utmost care to ensure that safe and effective products can make it to patients. It starts with the facility design and construction and is immediately followed by the manufacturing equipment selection, installation, and implementation. When choosing the correct equipment and systems for manufacturing, process scientists, process engineers, microbiologists, and […]
Advanced Aseptic Processing starts with the facility: To assure safety and efficacy of the medicines many rely on, the manufacturers must embrace advanced aseptic processing. To the regular person, this might sound like a fancy buzz phrase but to those in the industry and those creating the powerful therapeutics that patients rely on, this is a […]
Performance Validation, Inc. (PV) is thrilled to announce that Robert Perks has joined our team as the new Digital Solutions Director. This strategic addition to our team will significantly enhance our Automation and CSV services, including IT and OT CSV, Process Automation, Paperless Validation, and Digital Transformation initiatives. Robert’s extensive experience and expertise will undoubtedly […]
Automated Storage and Retrieval Systems (AS/RS) have revolutionized the landscape of material handling and storage, offering unprecedented efficiency and space optimization. However, the path to a seamlessly integrated AS/RS in a facility is fraught with challenges, especially during the validation phase. This critical stage is where theoretical designs and simulations confront the tangible realities of […]
In pharmaceutical and medical device manufacturing, the concepts of Commissioning, Qualification, and Validation (CQV) form the backbone of ensuring that equipment, systems, and processes operate as intended, consistently producing high-quality products. These activities are not just operational necessities; they are stringent regulatory requirements designed to safeguard patient safety. With a landscape governed by international standards […]
In the critical field of pharmaceutical manufacturing, where patient safety is paramount, the strength of our engineering teams is not just a matter of efficiency or productivity—it’s a matter of life and death. As leaders, our approach to building and nurturing these teams directly impacts the quality of our output and, ultimately, the safety of […]
In the fast-evolving world of pharmaceutical manufacturing, we stand at a crossroads where tradition meets innovation. As an industry, we are custodians of health, holding the safety of patients firmly in our hands. This immense responsibility, I believe, is shouldered not just by the meticulous processes we uphold but significantly by the manufacturing staff who […]
In the fast-paced world of pharmaceutical manufacturing, ensuring regulatory compliance and maintaining data integrity are crucial for success. That is why finding the right Commissioning, Qualification, and Validation (CQV) partner is essential. This blog explores the key factors that pharmaceutical manufacturers should consider when seeking a CQV provider to establish robust data governance practices. Establishing […]
September 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 […]
This 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 […]
Vice President of Services Products -
Brad has over 20 years of experience managing and executing CQV projects for the pharmaceutical and medical device industries. He has extensive experience in dry products, parenteral, facilities and utilities, and in-vitro diagnostics.
Vice President of Services Delivery -
With over 20 years of industry experience, John has been fortunate enough to experience all levels at PV and has provided services to the pharmaceutical and medical device manufacturing industries. He has extensive experience in dry products, parenteral, facilities and utilities, API, and computer systems.
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