Compliance

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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10
Sep
CAPAs

Effective CAPAs are the “Root” of Positive Change

CAPAs are one of the most important elements of the pharmaceutical Quality System.  During Day 1 of the PDA/FDA Joint Regulatory Meeting, Jonathan Chapman, Senior Policy Advisor at the FDA, spoke about CAPAs. Traditionally, we think of CAPAs as follows: Corrective actions are actions implemented to correct an identified problem. Preventive actions are actions implemented to […]

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09
Sep
Scientist working doing some research at a laboratory

Does Testing into Compliance Just Apply to Sample Release Test Data?

The WHO has a draft July 2013 guidance document titled “Deviation Handling and Quality Risk Management” that addresses the concept that not all Quality Events are equivalent and provides consideration for the classification of events.  For example, an incident would be an event that does not: “…affect a product attribute, manufacturing operational parameter or the […]

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28
Aug
Pharma What Can We Learn from the Infamous CrowdStrike Outage - Lachman Blog

Pharma, What Can We Learn from the Infamous CrowdStrike Outage?

A couple of months ago, when we returned from Barcelona to San Francisco, it was impossible to check in online for some reason. Then the news broke about flight disruptions due to the CrowdStrike software update! Some flights, including ours, were only a couple of hours delayed. However, many more passengers were affected even further […]

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