The Lachman Blog

Subscribe to our blog

30
Jan
SOP Standard operating procedure concept. A yellow folder lies on an office shelf.

How to Effectively Update SOPs for Compliance: Ensuring Alignment Across Procedures

When a firm receives an FDA 483 finding of “does not follow Standard Operating Procedures (SOPs) for performing X GMP activity,” the immediate response is often to revise or update that specific SOP with more detailed instructions.  While this might seem like the right thing to do for a quick fix, it is crucial to […]

Read More
28
Jan
Businessman checking a document

Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers: Guidance for Industry – Now, That’s a Mouthful!

Revision 2 of the FDA Guidance for Industry “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers” was published on January 6, 2025 and it finalizes the previous draft version.  This is a procedural guidance that applies to medical products regulated by CDER, CBER, CDRH, […]

Read More
27
Jan
Ireland USA Puzzle Concept

Friendshoring: Irish American Supply Chain Examined as a Case Study

How is your company reacting to threats in its supply chain and transforming risk into opportunity?  In a mature application of Quality Risk Management (QRM), companies should lean into the political winds of “onshoring,” “nearshoring,” and “friendshoring” as these concepts have been stood up as well-discussed risk mitigations to the current drug shortage problems.  These […]

Read More
27
Jan
Unemployed Job Seekers. Bored People Waiting

Final Rule Delayed Until at Least March 21, 2025

In a prepublication Federal Register notice (here), it was announced that the final rule “Nonprescription Drug Product With an Additional Condition for Nonprescription Use” has had its implementation date delayed until March 21, 2025. According to the notice, the “FDA published a final rule, titled ‘Nonprescription Drug Product With an Additional Condition for Nonprescription Use,’ in […]

Read More
27
Jan
Businesswoman Looking At Contract Form Through Magnifying Glass

Forgotten Investigation Elements: Historical Analysis

Investigations have historically been among the most commonly cited observations in FDA 483s so a robust investigation strategy is an important element of any firm’s quality program.  A strong investigation is supported by a thorough and complete evaluation of the major elements: root cause analysis, impact assessment and scope, historical analysis, establishment of CAPAs, and a […]

Read More
23
Jan

Synthetic Data: Real or Fake?

Whether you believe synthetic data to be real or fake, the overall market for it is expected to grow from $351.2 million in 2023 to $2,339.8 million by 2030 (Synthetic Data Generation Market Forecast | Fortune Business Insights).  This statistic can make the most hardened cynic’s ears perk up.  But, surely, in our world of regulated medicinal […]

Read More
1 2 3 231