02
Aug
Deadline.

Risk Meets Data Governance in the Supply Chain 

What do a cup of cappuccino and sterile water for injection have in common?  At first glance, there is no apparent correlation, except when you become “data curious” and take the macro view of the current convergence of economics, compliance, and maturation of risk management.  Sometimes utilizing existing data is the best way to understand […]

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09
Jun

Supply Chain Risk and Data Management Poised to Take a Leap Forward

In a complete supply chain, one site’s lag measure is another site’s lead measure.  As important as data integrity is to product quality decisions at the site, data risks in the supply chain can affect availability of product to patients.  As mentioned in a previous Lachman blog (here), drug shortages are the preeminent risk for […]

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15
Feb

Is Your Supply Chain at Risk?

Are your supply chain weaknesses putting patients at risk of not receiving safe, reliable medicines?  This could be a difficult self-reflection for weak supply chains, devastated by the pandemic.  The “race to the bottom” for cost and the cumulative effect of “lean-out” global supply chains have had an unintended consequence for the safe, reliable supply […]

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21
Nov

FDA Inspections Summit: Emerging from Covid and the Future of Data Integrity

The 17th Annual FDA Inspections Summit kicked off with high energy by keynote speaker Elizabeth Miller, Pharm.D., Assistant Commissioner for Medical Products and Tobacco Operations Regulatory Affairs who presented on the FDA perspective on inspections.  As the entire world emerges from the pandemic, it was reported that the ORA is holding “listening sessions” to see […]

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09
Nov

CDER Advisory Committee Votes to Progress Quality Management Maturity

Is a mature pharmaceutical quality system really a competitive advantage?  The industry held this as a belief, but progress in a tangible program was always elusive.  On  November 2nd, the CDER’s advisory committee, Pharmaceutical Science and Clinical Pharmacology Advisory Committee (PSCP‑AC), voted to establish a Quality Management Maturity (QMM) program to incentivize investments in mature […]

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28
Sep
Quality Agreements Image

Great Quality and Great Business Is Interdependence in Plain Sight?

If our supply chain was weak prior to the pandemic, this global event accelerated its failure.  These signals of weakness were laid bare during the pandemic  and identified in publications such as the 2019 report “Drug Shortages:  Root Causes and potential Solutions” (here).  Prior to the Covid PHE, focus on shortages was placed much more […]

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09
Sep

Annex 1: A Step Increase in Sterile Manufacturing Requirements

A 300% increase in anything gets attention, however, when it is a “rule governing medicinal product in the European Union” it demands attention and action (EudraLex – Volume 4 (europa.eu)).  Annex 1 which is the guide for the “Manufacture of Sterile Medicinal Products” (20220825_gmp-an1_en_0.pdf (europa.eu)) was just released on 22 August 2022.  This document is […]

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30
Aug

“GMP By the Sea” Reflections

In-person conferences continue to emerge as evidenced by the recent “GMP by the Sea” held on August 15, 16, 17th in Cambridge, MD.  A well balanced conference, led by regulatory leaders, provided relevant “look backs” as well as prospective “look forwards” giving attendees a collective perspective of learning from the past as well as a […]

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