Analytical Methods

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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14
Feb
Hand Holding a Chemical Solution Test-tube in a bio-Chemistry DNA Research Laboratory

CBER Publishes a Boatload of New Gene Therapy Guidances

  January was a gangbuster month for the FDA’s Center for Biologics Evaluation and Research (CBER) with regard to publication of gene therapy (GT) guidance documents!  A total of six final guidelines and one draft guideline on GT products were issued.  These included: Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug […]

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13
Feb
Fingerprint

What Is It? – Identity Testing Re-visited

In earlier blogs, we have written about specific technical items related to identity testing.  However, a review of Warning Letters published on the US FDA website for the months of December 2019 and January 2020, revealed three Warning Letters citing instances of failures to perform identity testing of active pharmaceutical ingredients prior to the manufacturing […]

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10
Feb
Concept For Compliance For Services On Virtual Screen

The Importance of Sampling Plans for Uniformity of Dosage Testing

Numerous health authorities have cited companies for inadequate sampling plans of finished drug products. A recent 483 issued to a finished drug‑product firm specifically mentions the firm’s lack of a scientifically sound statistical sampling plan during production of all strengths of its drug product.  The FDA also mentions that this firm uses content uniformity results […]

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06
Feb
Abstract Molecular Structure

Revisiting the “Novelty” of Novel Excipients

February 3, 2020 was the last day to comment on the Food and Drug Administration’s (FDA) notice in the Federal Register on the Novel Excipient Review Program Proposal; Request for Information and Comments (here), which we reported on in a previous blog post (here).  In this notice, the FDA had proposed a pilot program related […]

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05
Feb
Researcher adding liquid from test tube with fire symbol, warning sign, danger

The “Unwelcome Guest” Spares Metformin

Recently, FDA has posted (here) that Metformin, from several sources, tested by FDA showed that the levels of N-nitroso-dimethylamine (NDMA) in the drug are below the levels of detection (here).  Great news!  NDMA belongs to the nitrosamine family, and is one of the well-known animal carcinogens and a suspected human carcinogen.  The nitrosamines, including NDMA, […]

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28
May

USP Chapter Spectroscopy Identification Tests – Controlling Your Identities!

This post was co-authored by Thu Truong, J.D., Senior Associate, Science and Technology Group, and Ron George, Ph.D, Director, Science and Technology Group Prior to USP 42 – NF 37 (effective April 30, 2019), USP Chapter <197>, Spectroscopy Identification Tests, stated, “The IR absorption spectrum of a substance, compared with that obtained concomitantly for the […]

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03
Jan

ICH Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation – A Step towards Modernizing to Current Standards and Technology?

Recently, the ICH has communicated the intention to develop a new ICH Quality Guideline, ICH Q14, on Analytical Procedure Development, and revise the ICH Q2(R1) Guideline on Validation of Analytical Procedures (here), where ultimately both documents may be combined into one document. This is welcome news as ICH Q2(R1) is long overdue for revision (current […]

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