This blog post focuses on the unprocessed, processed, and re-processed chromatographic data (e.g., data generated using chromatographic instruments such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultra Performance Liquid Chromatography (UPLC), etc.). To some operators, the unprocessed chromatographic data might not be recognized, nor would they raise any concerns with the validity of the […]
It has been more than twelve years since the concept of Data Integrity was introduced formally to industry, and widely discussed throughout the industry, and yet, to this day, we continue to see how industry struggles with it. This blog post discusses some of the fundamental topics clarifying what data integrity is and how to […]
Join us November 28, 2023 / 14:00 – 15:00 GMT / 9:00AM – 10:00AM EST for A Lachman Learning Experience. Data integrity is an ever-increasing concern in life sciences for the purpose of ensuring safety and enhancing quality among all manufacturers. Coming under recent scrutiny is data integrity and its far-reaching impact on manufacturing safety […]
Did you ever want to do something to help half a million consumers (on average) who are impacted by a drug shortages? This may seem daunting and based on the last few years almost impossible, but the first step is clear: increase your or your company’s awareness of the situation. Knowledge is power. Lachman is […]
If you are responsible for data integrity for your company and you limit your thinking to Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs), you may be creating your own vulnerability. For too long, the “unloved” business continuity plan has been a paper exercise rather than a true investment in protection of a true […]
ISPE 2023 Annual Meeting Mandalay Bay Resort Las Vegas, NV October 16th – 18th, 2023 We are looking forward to seeing you at the 2023 ISPE Annual Meeting & Expo. This annual event will usher in a revitalized focus on excellence, modernization, and harmonization in pharmaceutical science and manufacturing. MEET WITH LACHMAN CONSULTANTS AT BOOTH […]
The FDA has issued a white paper on “CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development.” The paper details a program the center intends to establish whereby the goal is to promote QMM throughout the industry. Lachman recently issued a blog relating to this initiative that can be found here. […]
As Asia’s top financial hub and one of the top five busiest shipping ports in the world, Singapore is also one of Asia’s most modern. Recognized for its focus on strategic urban planning and renovation, innovative architecture, green sustainable initiatives, cultural diversity and high living standards, Singapore is a business-friendly city of high aspirations and […]
As U.S. consumers are facing critical drug shortages, leading Congress to question the FDA’s foreign inspection program, particularly for products with supply chains from India and China, the oversight of CGMP inspections is high on the Agency’s radar. With approximately 32% of generic drugs and 45% of active pharmaceutical ingredients (APIs) from these two countries, […]
Join Lachman Consultant Services, Inc. at PARKROYAL on Beach Road, Singapore for the 2023 PDA Pharmaceutical Manufacturing and Quality Conference, August 15th – 16th. The conference theme is “The Way Forward: Trends, Technologies and New Regulations Transforming Pharmaceutical Manufacturing.” Lachman Consultants is pleased to have Scott Deckebach, Senior Director of Data Integrity and Compliance, as […]
