Science & Technology

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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06
Nov
The Answers May be in What Is Not Stated Image

The Answers May be in What Is Not Stated – Drug Substance and Drug Product Manufacturers – Partnering to Improve the Process

An interesting session during the GRx+Biosims conference held in Bethesda on November 4, 2019 addressed Drug Substance and Drug Product Manufacturers – Partnering to Improve the Process.  The presentations from the FDA, as well as industry, acknowledged that the adequacy of drug master files (DMFs) for APIs in one cycle has been a lot more […]

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05
Nov
Keeping an Eye on The Ultimate Goal Image

Keeping an Eye on The Ultimate Goal – How to Ensure Success In Developing Complex Generics

One of the popular sessions in GRx+Biosims Conference held in Bethesda on November 4, 2019 was about Developing Complex Generic Products – How to Ensure Success. The session involved presentation and discussion by FDA and industry. Both sides agreed that the most important factor in assuring success in the development of complex generic is communication, […]

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29
Oct
Nitrosamines – Expensive Witch Hunt or Very Broad Safety Concern Image

Nitrosamines – Expensive Witch Hunt or Very Broad Safety Concern?

I have recently touched upon the subject of nitrosamines in drug products as part of a blog on Extraneous Peaks (here).  The concern about nitrosamines in drug products continues to grow, and it will be a significant challenge for the regulators and pharmaceutical industry to establish meaningful policies and procedures to ensure there are no […]

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10
Oct

Proactive Evaluation of Possible Genotoxic Impurities During the Early Stages of Drug Development

[vc_row][vc_column css=”.vc_custom_1570720331401{margin-bottom: 20px !important;}”][vc_column_text]Aloka Srinivasan, Vice President, Regulatory Practice at Lachman Consultants recently wrote an article for PharmTech, detailing the Proactive Evaluation of Possible Genotoxic Impurities During the Early Stages of Drug Development. The article provides a direction for identifying genotoxic impurities early in the drug development process, regulating genotoxic impurities at acceptable levels in […]

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18
Sep
Continuous Manufacturing and its Regulatory Challenge Image

Continuous Manufacturing and its Regulatory Challenge

So, what is the buzz about continuous manufacturing (CM)? What benefits does it bring to the manufacturer and what are the regulatory challenges? The author of this Contract Pharma article, José L. Toro, Ph.D. of Lachman Consultants, discusses the current thinking on the benefits of CM and the regulatory hurdles a manufacturer has to overcome. […]

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18
Sep
Extraneous Chromatographic Peaks Image

Extraneous Chromatographic Peaks – What’s a Lab to Do?

Recently, the United States Pharmacopeia and National Formulary (USP-NF) announced a three-month public consultation period on a proposal to change the approach to impurity reporting thresholds for drug products and drug substance monographs[i].  This activity is part of the USP-NF’s ongoing efforts to ensure that monographs reflect technical advances and current regulatory expectations.  In 2016, […]

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09
Sep
Scientific and Technical Assistance

Bioanalytical Laboratories:  What to Do with Variable Internal Standard Response?

For all Sponsors submitting INDs, NDAs, ANDAs, BLAs, and supplements, and the bioanalytical laboratories analyzing and reporting the data to support these submissions, the FDA just issued its Guidance for Industry, “Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers.”  The Q&A guidance contains five questions, along with the Agency’s current thinking on […]

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