What is Quality Audit in Pharma

-Quality audit means a systematic examination of a quality system.

 

-Quality audits are typically performed at defined intervals and ensures that the institution has clearly defined internal quality monitoring procedures linked to effective action.

-The checking determines if the quality system complies with applicable regulations or standards.

-The process involves assessing the standard operating procedures for compliance to the regulations and also assessing the actual process and results against what is started in the SOP.

Objective of Audit:

-To ensure the quality, all pharmaceutical manufacturers are required  to establish and implement as effective pharmaceutical QA system.

-To assess the effectiveness of these QA systems and to ensure it follow GMP, self inspection and other regulatory audits must be performed.

-Pharmaceutical manufacturers commonly use audits as effective mechanism to verify compliance with  GMPs.

-Audits are intended to verify manufacturing control systems are operating under the state of control. It also lead trouble free operation.

-Audit can be detect potential problems to permit timely correction

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-Audits can be used to establish with a high range of confidence to remain adequate level of control by management.

-  Indirectly improve the performance