Compliance

04
Nov
Laptop Cartoon - Thinking

Cybersecurity and AI: Navigating the Digital Frontier

In an era of rapid technological breakthroughs, the incorporation of artificial intelligence (AI) into numerous industries is transforming the way in which we all work. AI has been shown to be a valuable tool for automating mundane processes and analyzing large datasets. However, as we embrace its potential, we must also address the cybersecurity threats […]

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01
Nov
Female biologist testing the oxygen levels in the river

Water Conductivity Testing: More Than a Simple Test

Water is a critical component used in the manufacture of pharmaceutical products, and it must meet specific quality standards in order to demonstrate that the water intended to be used for manufacture is suitable for its intended purposes.  USP <1231> on Water for Pharmaceutical Purposes provides an overview of the different water types used in manufacturing, […]

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01
Nov
Blog Brief on Several FDA Actions and Topics of Interest - Lachman Blog Image 2

Brief on Several FDA Actions and Topics of Interest

Baxter Recovery and FDA Actions The FDA announced additional actions “to increase access to and supply of IV and peritoneal dialysis (PD) solutions following Hurricane Helene-related damage to Baxter International Inc.’s North Cove facility in Marion, North Carolina.”  The FDA performed assessments to enable import of IV solutions and PD solutions from seven different Baxter […]

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31
Oct
young professional who is writing down math formulas

Are Your Methods Fit for Purpose?

When addressing the requirements of analytical test procedures, 21 CFR 211.160 states: “Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.” 21 CFR […]

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14
Oct
Paper clipboard with text POLICIES AND PROCEDURES.

More Compounding News – Temporary Policy on Certain Parenteral Products

As of October 10, 2024, pursuant to section 319(a) of the Public Health Service Act (PHS Act), Department of Health and Human Services (DHHS) Secretary Becerra has determined that public health emergencies (PHEs) resulted from the devastation caused by hurricanes Helene and Milton.  Because of the disruption to the availability of certain parenteral products, the […]

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10
Oct
FDA Grants Exemption to Connected Trading Partners - Lachman Blog

FDA Grants Exemption to Connected Trading Partners

Though the FDA had indicated previously that it would not extend the deadline for full implementation of Drug Supply Chain Security Act (DSCSA) requirements, discretion appears to have become the better part of valor. On June 13, 2024, we posted a blog about waivers that would be available for certain small dispensers, and yesterday the FDA […]

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11
Sep
PDA Conference Day 2 - An Overview - Lachman Consultants

PDA Conference Day 2 – An Overview

Day 2 of the 2024 PDA/FDA Joint Regulatory Conference kicked off in a similar format to Day 1 with a panel discussion, moderated by Andrew Hopkins, that delivered key messages from various FDA leaders.  An explanation of the imminent changes in the Agency’s organizational structure (CBER, CDER, and CVM) dominated the conversation.  However, an impactful response from […]

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11
Sep
PDA/FDA Joint Regulatory Conference 2024 - Day 1

PDA/FDA Joint Regulatory Conference 2024 – Day 1

It’s been a pleasure to return to the PDA/FDA’s 2024 Joint Regulatory Conference.  This is the first FDA co-sponsored conference that I’ve attended since my retirement from the Agency in 2023, and it has a bit of a high-school-reunion atmosphere for me.  I’m grateful for the friendships with my FDA colleagues that have extended beyond […]

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