New Warning Letters - Quality Units in the Focus

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7/8 May 2024

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The U.S. Food and Drug Administration FDA keeps on issuing new Warning Letters. In some of the latest, the role of the Quality Unit is criticised.

Production and laboratory processes are for sure still a hot topic in inspections. But inspectors are also focussing on the role of the Quality Units. In the recent Warning Letters of the FDA, their failures are cited more often now.

Rxhomeo Private Limited for example was criticised because the "firm's quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP"!
Structure, function and responsibilities of the Quality Unit (QU) are not described. Even worse, manufacturing units and the QU are not independent. The same operators that manufacture the drug products also authorise review and release. Procedures for many quality and production processes were not established, and the quality unit (QU) "failed to provide adequate oversight" over the manufacturing processes.

Furthermore, the company's batch records lack important details; some products even share a single master batch record.

The quality unit of the Chinese Company Xi'an Livingbond Nonwoven Products Corp. seems to have similar problems. Their quality unit also "failed to establish written procedures for multiple responsibilities", like for example cGMP training, annual product review (APR), and stability program.

FDA sums it up in one sentence: "Your firm's quality systems are inadequate" and refers to FDA's guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations to help "implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211".