On May 1, 2024, the first version of USP General Chapter <1079.4> on Temperature Mapping for the Qualification of Storage Areas became official, and it is the fourth part of USP General Chapter <1079> on Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products, which also includes: USP General Chapter <1079.1> on Storage and Transportation […]
Dealing with different product requirements is often difficult, especially when the regulation office or center may differ as well. Over the years, individual post-approval change requirements have been scattered in documents from different centers and, if you have a good enough memory, then maybe you picked the right reporting requirement based on the product and […]
In pharmaceuticals, maintaining product quality and safety is paramount. Visual inspection plays a vital role in detecting particulate matter and/or container/closure defects, though it may fall short in pinpointing the root cause of defects or material origins. To fortify visual inspection programs effectively, a comprehensive risk assessment serves as the foundational pillar. This blog delves […]
With the recent news of cuts in FDA funding (most recently reported by Zachary Brennan in an Endpoints News story entitled, “House Committee Raises Concerns on CDER-CBER Misalignment Amid 2025 Funding Markup” (here, subscription required), the question of FDA being asked to do more must be asked, as it now appears it will have to […]
The manufacturing landscape for cell and gene therapies is evolving rapidly, driven by the need for greater flexibility, efficiency, and proximity to patients. Two prominent models have emerged: Distributed Manufacturing (DM) and Point of Care Manufacturing (POC-M). Both approaches have unique benefits and challenges, particularly concerning quality control and regulatory compliance. This blog explores the […]
Each year, the Office of Pharmaceutical Quality (OPQ) releases a report on the state of pharmaceutical quality. This year’s report was released yesterday and can be found here. Every year we try to pick out key issues and highlight some of the statistics outlined in the report, and this year is no different! Some important […]
It’s fascinating to see the evolution and potential future of visual inspection in the pharmaceutical industry. The shift from manual methods to cutting-edge automated systems with artificial intelligence has significantly improved efficiency, accuracy, and reliability in product inspections. By leveraging AI technology in visual inspections, pharmaceutical companies can benefit from enhanced defect detection capabilities, greater […]
Container Closure Integrity (CCI) testing is a central aspect of contamination control for a product. Contamination control strategy begins with the design, qualification, and validation of a facility, equipment, and processes. Product containers and closures are a crucial element of contamination control. Package integrity is the ability of the package to prevent loss, maintain sterility, […]
Today, the FDA released a draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers (here). Try saying that without taking a breath! This draft is a revision of the initial draft guidance issued on February 4, 2020 (85 FR 6201) (the 2020 draft guidance). The […]
You’re invited to visit with Lachman at Booth #47. We hope to see you at the 10th Anniversary American Biomanufacturing Summit, one of the can’t-miss events of the year. It’s taking place on April 10-11, 2024, at the Hyatt Regency San Francisco Airport, San Francisco, CA. The American Biomanufacturing Summit is one of the most senior-level […]
