Quality Audit

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.

Definition of GMP Audit

It is a documented, systematic tool used by management and done periodically by independent, qualified people to verify and evaluate an organizations use of the principles of good manufacturing practices and compliance to applicable GMP regulations.

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.

Step to Perform a Quality Audit

Key steps included: Define and goal of the audit. Identify areas and product to be audited. Select the type of audit. Define the audit approach to be used. Identify the team leader and members. Identify a date and tentative audit schedule. Define audit report format and distribution.

Type of Quality Audit

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

Implement the Internal Audit Program

Constitute a small team of experts

Provide Initial training

Fix Audit schedule(carried out at least once in six months)

Report the Audit finding and report given to top management and shows corrective actions

Repeat the audit as per preplanned schedule

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

Procedure of a Quality Audit

Audit Planning and Preparation Success or failure of audit in achieving its objectives depends on the advance planning and preparation. If audit is to be performed by a team, then team leader should be decided in advance.