Data Integrity

25
Jun

Lachman OnCall™ GMP Teleconsulting – When you can’t wait to get going.

When you can’t wait for answers to your GMP questions, it’s time for Lachman OnCall™. Our Subject Matter Experts (SMEs) understand you need advice right away. Lachman’s SMEs have the knowledge, experience, and skills to address your most urgent scientific, technology, and compliance-related questions, such as: “We had to shut down our sterile manufacturing plant […]

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08
Jun

Data Integrity Issues Still Plague Pharmaceutical Manufacturers – Where’s the Beef?

I know that I have written about this issue multiple times (here and here; also search our blog for other data integrity posts) and I guess it is a holdover from my time at FDA and living through the generic drug scandal of the late 1980s, but, come on now, folks, the FDA’s bark seems […]

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01
Jun

Data Integrity: Beyond Electronic Records

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 […]

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21
Feb
Leadership Concepts with Arrows on Blackboad Background

Data Integrity – Management’s Responsibilities

Since the initial April 2016 draft published, the pharmaceutical industry has been working to toward complying with the FDA guidance on Data Integrity and Compliance With Drug CGMP (here) which was finalized in December 2018.  One passage in the introduction of the guidance has resonated with me: “Management’s involvement in and influence on these strategies […]

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18
Feb
Businessman examines a tablet with a magnifying glass. Concept of internet security

Out-of-Specification Investigations – Lessons Learned, or Not?

The FDA Guidance for Industry, Investigating Out‑of-Specification (OOS) Test Results for Pharmaceutical Production, was published in October 2006 (here).  The pharmaceutical industry has had about 14 years to learn how to comply to this guidance.  A quick survey of recent Form 483s and Warning Letters would indicate that there is still much to be learned […]

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08
Jan

The Role of Risk Assessment within Data Integrity

The World Health Organization (WHO) issued a draft guidance document titled “Guideline on Data Integrity” (October 2019) and within the document there is the statement: “Quality risk management (QRM), control strategies and sound scientific principles are required to mitigate such (Data Integrity) risks” and then further it states: “application of QRM with identification of all […]

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25
Jun

Frances Zipp Shares Market Insights at the CPhI China Exhibition in Shanghai

On June 20, 2019, LCS’ President and CEO Fran Zipp, moderated a panel at the CPhI China exhibition in Shanghai, organized by Informa Markets. The panel discussion, “How Can International and Domestic Manufacturers Collaborate to Improve Quality?” included members from a number of different segments of the regulated industry. Members on the panel were: Aurelio […]

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20
Dec

Happy Holidays from Us to You!

To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year.  The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as […]

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