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, […]
Unless you’ve been living under a (pharmaceutical) rock, you are aware of the struggle that both FDA and industry are having with Nitrosamines impurities in pharmaceutical products. As a reminder, APIs are at risk of forming nitrosamine drug substance-related impurities (NDSRIs) when they contain secondary amines or dimethyl tertiary amines. We have published many blogs […]
Join Lachman Consultant Services, Inc. online and in-person at Suntec Singapore for the 2023 ISPE Singapore Affiliate Conference & Exhibition, August 23rd – 25th. The exhibition showcases the latest technologies and services for pharmaceutical and biomanufacturing. The three-day conference is expected to include more than ninety international exhibitors and sponsors. Lachman Consultants is pleased to […]
In our previous installment, Tamil Arasu, former investigator with FDA, detailed preparations that a firm can make in advance of an FDA inspection, as well as details on the types of inspections that FDA performs on drug firms. In today’s post, Tamil will describe appropriate conduct during an inspection, including both the personnel that will […]
When an FDA investigator walks into your facility and informs you that they are going to conduct an inspection, a tense moment may arise even at the most cGMP (Current Good Manufacturing Practices) compliant facility. Paging the employees to inform them of the presence of FDA at the facility is a common occurrence so that […]
Paul Mason, Ph.D., Lachman Consultants, wrote an article for Contract Pharma covering “The Importance of Data Integrity Risk Assessment.” Here is a brief excerpt from the article: “The FDA and other Health Agencies have an expectation that companies understand the capability of their systems that generate and store data/records including any data integrity risks associated […]
Ricki A. Chase, M.S, Lachman Consultants, wrote a recent article for Contract Pharma looking at the benefits and challenges of the trend towards combination products. Here is a brief excerpt from the article: “As the life sciences industries have continued to evolve, the need for ever changing nomenclature has evolved along with it. It was […]
Paul Mason, PhD, Lachman Consultants, wrote a recent article for Contract Pharma discussing why it is critical to have controls in place during out-of-specification investigations to provide quality assurance. Here is a brief excerpt from the article: “While being audited by government health agencies, it can be expected that quality investigations will be reviewed since […]
Contract Pharma recently published an article written by Timothy Rhines, Ph.D., Director in the Science and Technology Practice of Lachman Consultants. He discusses how to get your data integrity house in order. Here is a brief excerpt from the article: “The global pharmaceutical industry has been grappling with the regulatory agencies’ focus on data integrity […]
