Question

According to the QSR, Quality Audits must accomplish the following:

A) Meet the same requirements of the original GMP
B) Evaluate if the Quality System is in compliance with the QSR
C) Determine the effectiveness of the Quality System
D) Focus on Design Controls and the CAPA system
E) B and C above
F) A and D above

Answer 1

Quality Audits under the QSR must evaluate the compliance of the Quality System with the QSR, with B and C being the correct answer.

Step-by-step explanation:

This means that the correct answer to the question is E) B and C above. Quality audits are structured evaluations that systematically assess whether the quality activities and results comply with planned arrangements and whether these arrangements are effectively implemented and suitable to achieve the objectives.

When conducting quality audits, it's essential to identify criteria and constraints. Criteria refer to the measurable attributes that the quality system must attain to be considered effective.

Quality audits do not necessarily need to meet the same requirements of the original Good Manufacturing Practice (GMP) or focus exclusively on Design Controls and the Corrective and Preventive Action (CAPA) system, although these areas can be included as part of the audit scope.