Pharmaceutical industry

26
Jan

Lachman Consultants will be at Access! 2024 in February. Will you?

As a proud Silver Sponsor of this important conference, we’ll be looking for you at Access! 2024. This annual meeting of the Association for Accessible Medicines (AAM) is happening in Tampa, Florida at the JW Marriott from Monday, February 5th through Wednesday, February 7th, 2024. Visit with us at Booth #11. The Lachman Consultants team […]

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26
Oct

Join Lachman Consultants (Ireland) at the PDA Quality and Regulations Conference in Belgium

Lachman Consultants (Ireland) will participate at this year’s PDA Quality and Regulations Conference in Antwerp, Belgium, November 7 – 8. The two-day in-person event will cover a wide range of topics related to regulatory and industry best practices, with a particular emphasis on addressing shortages and enhancing supply chain resilience. Lachman Consultants (Ireland) will be […]

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11
Oct

Connect With the Lachman Consultants Team at the 2023 ISPE Annual Meeting

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 […]

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07
Sep
PDA Pharma Mfg Conference 2023 1- Lachman Consultants

The Singapore PDA Manufacturing and Quality Conference – The Future of Pharma in a City of the Future

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 […]

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24
Aug
Mock-Inspection-Blog-image-Lachman-Consultants

5 Reasons Why You Should Perform a Mock Inspection Now

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, […]

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04
Aug

New Guidance for Industry- Acceptable Intake Limits for NDSRIs and a New Webpage from FDA

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 […]

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03
Aug

Connect with Lachman Consultants at ISPE Singapore Affiliate Conference & Exhibition August 23 – 25, 2023

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 […]

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01
Jul

How to Prepare for an FDA Inspection – Important Things to Know from the Perspective of a Former Investigator (Part 2)

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 […]

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30
Jun

How to Prepare for an FDA Inspection – Important Things to Know from the Perspective of a Former Investigator (Part 1)

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 […]

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07
Jul

The Importance of Data Integrity Risk Assessment

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 […]

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