Inspections

26
Jun

Mastering Drug Product Remediation: 5 Essential Principles Post FDA Action 

In the realm of pharmaceuticals, navigating the intricate landscape of facility and Quality Management System (QMS) remediation following FDA enforcement actions demands precision, foresight, and a commitment to sustainable change. When faced with regulatory scrutiny, it is imperative for companies to not only address the identified issues but also to comprehensively understand the root causes […]

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21
Feb

Join Lachman Consultants (Ireland) at the PDA Ireland Event: Contract Manufacturing – Achieving & Maintaining a Successful Partnership, Cork, 29th Feb.

The one-day event will explore how to achieve and maintain good relationships with your Contract Manufacturer Organisation (CMO) Partners. Key industry leaders will share their perspectives on many topics such as the selection of a service provider, regulatory trends, and how to foster collaborative synergies when outsourcing. Lachman Consultants (Ireland) provides a full range of […]

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10
Nov

A New Approach to cGMP Inspections is Coming Soon. Our Contract Pharma Article Gives You a Preview.

Earlier this year, the FDA issued a draft Guidance for Industry titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry.” The proposed Guidance uses a risk-based approach based on product quality or facility-related risks and will be determined on a case-by-case basis by the FDA. Are you among the many […]

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01
Sep

Is your company suitably staffed? Our article in Contract Pharma takes this issue head on.

According to reports, the pharmaceutical job market has been expanding exponentially in recent months and is on an upward trajectory for job seekers. Occupational profiles are changing and many existing jobs, as a result of automation, are evolving, while completely new jobs are emerging. In this post-pandemic growth period, pharmaceutical companies are beginning to recognize […]

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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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10
Aug

Is Your Company “Inspection Ready?” Our article in Contract Pharma will help you be better prepared.

It has been more than a year-and-a-half since the FDA released its publication “An update to the Resiliency Roadmap for FDA Inspections.” Are you among the many companies wanting to stay current and who can benefit from some assistance in creating an executable year-to-year plan to maintain both long and short-term inspection proactivity? If so, […]

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05
May

Ready for an FDA Inspection? Be prepared. Read our Contract Pharma article.

Being proactive is always better than being reactive. And when it comes to a possible “visit” from FDA, anticipation and preparation go a long way in lowering anxiety and navigating the process successfully. Knock, knock. When an FDA investigator walks into your facility informing that they are going to conduct an inspection, a tense moment […]

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05
Jul

How to Prepare for an FDA Inspection – Important Things to Know, from the Perspective of a Former Investigator (Part 3)

In our previous installment on inspectional preparation and conduct, we covered recommended actions to be inspection ready, how to interact with FDA, and how personnel should conduct themselves during an FDA inspection. In today’s installment, we will cover what happens after the inspection, focusing on responding to an FDA 483 and inspectional outcome decision making. […]

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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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