Quality audit define as a systematic and independent examination to determine whether activities and related result comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives
Quality audit means a systematic examination of a quality system. Quality audits are typically performed at defined intervals Any failure in the proper implementation may be published publicly and may lead to a revocation of quality certificate.
Advantages of Audit
An audit will show how activities and existing system are being used at time of audit. Audit can not only identify the problem but also point out the root and contributing causes of the problems.
Internal Audits
External Audits
Regulatory Audits
Internal Audit
To ensure that adequate quality systems are maintained To assas compliance with the C-GMPs and firms standard operating procedure To achieve consistency between manufacturing and testing facilities To identify problems internally and correct problems prior to a FDA inspection
Report the Audit finding and report given to top management and shows corrective actions
External Audit
Purpose of External Audit: Confidence in the partnership arrangement Ensuring that requirements are understood Enabling reduction of in- house QC testing of starting materials Reducing the risk of failure Carried out by a company on its vendors or sub contractors
No legal requirement for to conduct audit Regular audits will be carried out to assesses compliance with agreed standards Increase confidence in vendor auditing Reduce level of external auditing
Regulatory Audit
Purpose of Regulatory audit: Networking and confidence- building between national inspection authorities Development of quality systems Work towards global harmonization of GMP