Bioanalytical Archives - Lachman Consultant Services, Inc.

Will you be joining us at the American Biomanufacturing Summit?

By Webmaster Lachman Mar 27, 2024 Bioanalytical Biologics Emerging Technology Manufacturing News Pharmaceutical industry Quality Quality control Quality issues Regulatory Affairs Regulatory intelligence

You’re invited to visit with Lachman at Booth #47. We hope to see you at the 10th Anniversary American Biomanufacturing Summit, one of the can’t-miss events of the year. It’s taking place on April 10-11, 2024, at the Hyatt Regency San Francisco Airport, San Francisco, CA. The American Biomanufacturing Summit is one of the most senior-level […]

Oct

Connect With the Lachman Consultants Team at the 2023 ISPE Annual Meeting

By Matt Taylor Oct 11, 2023 Analytical Methods Bioanalytical Data Integrity Pharmaceutical industry Regulatory Affairs Regulatory intelligence

ISPE 2023 Annual Meeting Mandalay Bay Resort Las Vegas, NV October 16th – 18th, 2023 We are looking forward to seeing you at the 2023 ISPE Annual Meeting & Expo. This annual event will usher in a revitalized focus on excellence, modernization, and harmonization in pharmaceutical science and manufacturing. MEET WITH LACHMAN CONSULTANTS AT BOOTH […]

Aug

New Guidance for Industry- Acceptable Intake Limits for NDSRIs and a New Webpage from FDA

By Rebecca Welton Aug 04, 2023 Analytical Methods ANDAs Applications Bioanalytical Biologics cGMPs CMC Compliance FDA Generics Guidance for Industry Industry Manufacturing NDSRI New Drugs Nitrosamines OTC Pharmaceutical industry Quality Regulatory Affairs Risk Management Safety

Unless you’ve been living under a (pharmaceutical) rock, you are aware of the struggle that both FDA and industry are having with Nitrosamines impurities in pharmaceutical products. As a reminder, APIs are at risk of forming nitrosamine drug substance-related impurities (NDSRIs) when they contain secondary amines or dimethyl tertiary amines. We have published many blogs […]

Feb

Glimpses of What’s Ahead – FY 2019 GDUFA Science and Research Report

By Amy Schutte Feb 24, 2020 ANDAs Approvals Bioanalytical Bioequivalence Biologics Brand Name Drugs CBER CDER CMC Complex Generics Emerging Technology FDA Generics NDA New Drugs Regulatory Affairs Science & Technology

The FDA issued its Fiscal Year (FY) GDUFA Science and Research Report last week (read the full report here and the awarded research contracts and grants here). A review of the innovative scientific focus areas helps those of us in the industry to get a sense of where the FDA is headed in support of […]

Feb

Leadership Concepts with Arrows on Blackboad Background

Data Integrity – Management’s Responsibilities

By Tim Rhines, Ph.D Feb 21, 2020 Analytical Methods Bioanalytical Chemistry Data Integrity Laboratories Quality

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 […]

Feb

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

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

By Ron George, Ph.D. Feb 18, 2020 Analytical Methods Bioanalytical Bioequivalence CBER CDER Chemistry CMC Compliance Data Integrity Laboratories Manufacturing Quality

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 […]

Nov

Hope at This Time of Giving Thanks

By Bob Pollock Nov 26, 2019 505(b)(2) Abuse deterrent Accelerated Approval Advertising Analytical Methods ANDAs Approvals Bioanalytical Bioequivalence Biologics Biosimilars BLA Brand Name Drugs Bulk Drugs List CBER CDER Chemistry Clinical CMC Combination Products Complex Generics Compliance Compounders Compounding Controlled correspondence CVM Data Integrity DEA Device Dietary Supplements Drug Pricing Drug Shortages eCTD Emerging Technology Enforcement Exclusivity FDA FDA First Generics Foods GDUFA Fees Generics Guidance Homeopathic Drugs ICH Imports International Label Changes Labeling Laboratories Manufacturing Medical Devices NDA New Drugs OGD Opioids OTC Petitions PMA Post Approval projectsnowflake Receipts Regulatory Affairs Safety Science & Technology Shortages Training Uncategorized User Fees Validation

Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]

Apr

Bioanalytical Workshop Generates Question on FDA vs. ICH Guidance

By David O'Connor Apr 05, 2019 Bioanalytical Bioequivalence FDA Science & Technology

The 13th annual WRIB (Workshop on Recent Issues of Bioanalysis) was held in New Orleans, LA this week and is wrapping up today. The workshop was well represented by regulators and industry (both from Pharma and CROs), with numerous discussions and topics for the bioanalysis of small and large molecules. Presentations covered the full spectrum […]