Laboratories

12
Aug

Analytical Data Review:  The Thankless Job

In any analytical laboratory that performs cGMP testing, data review is required.  However, to an analytical chemist that prefers benchwork, reviewing the data of a fellow analyst is often deemed an undesirable chore.  The data reviewer rarely gets a “Thank you” for pointing out irregularities in documentation.  The role of the data reviewer is to […]

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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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06
Dec
Training Fundimentals

Training Fundamentals: Important to Baseball and the Analytical Laboratory

Training Fundamentals: Important to Baseball and the Analytical Laboratory By Tim Rhines, Ph.D | December 6, 2019 | Compliance, FDA, Laboratories, Science & Technology |  3 | Baseball season ended over a month ago, and I am already looking forward to when teams report for spring training.  At this time, team management is evaluating where the team succeeded and where improvement is needed.  It […]

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11
Jul

Ready or Not Here They Come – Lab Regulatory Inspections

Like death and taxes, eventually every pharmaceutical testing laboratory will get a regulatory agency inspection.  The anticipation of a regulatory inspection will instill great angst even within the most compliant laboratories.  The anticipated inspection might be a periodic inspection, but most often is a Pre-Approval Inspection (PAI).  The anxiety about an impending inspection often triggers […]

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