July 18, 2008

The FDA issued 74 good manufacturing practice (GMP)-related warning letters to device firms last year, 84 percent of which contained citations for Corrective Action Preventive Action (CAPA) system deficiencies.

FDA Focusing:

  1. On CAPA system deficiencies
  2. On right to review all CAPAs even when companies begin them as a result of internal audits


CAPA management is integral to meet the FDA’s expectations and its GMP regulations. More than just a regulatory requirement, effective CAPA management also is a good business practice that can reduce company liability and warranty claims and increase customer satisfaction.


Effective CAPA systems reduce regulatory risk by managing and streamlining the quality-reporting process.


  1. Reduces bad inventory
  2. Generates fewer regulatory warnings and recalls, and
  3. Increasing company profits and customer satisfaction

More here>>

A must training of individuals involved in carrying out research in human subjects

July 18, 2008

The US government is considering setting up a register of institutional review boards (IRBs) and asking for enhanced training of individuals involved in carrying out research in human subjects.

Reason behind training

The move follows a damning report on the US Food and Drug Administration’s oversight of clinical trials, published in September 2007 by Daniel Levinson, the inspector general of the Department of Health and Human Services (DHHS).

Among the deficiencies noted in the report were that the FDA did not have any clear picture of the number of trials being conducted in human subjects and low rates of clinical trial site auditing (less than 1 per cent). Of the estimated 350,000 trial sites the FDA was believed to have inspected 2,855.

What FDA Focus more during inspection is:

Moreover, when inspections did take place, they generally targeted completed trials and often focussed on verifying the quality of the data rather than human subject protection, according to the report.

What the US offices are looking for

  • Training
  • Educational programmes


The implementation of such training and education programs might help to ensure that individuals involved in the conduct or review of human subjects research at institutions … understand and meet their regulatory responsibilities for protecting human subjects.