A quality audit is an independent evaluation performed to review if activities are performed in a manner to comply with set objectives defined in the company’s quality system. In the pharmaceutical industry, audits are an effective means of verifying if the different departments comply with cGMP regulations.
Purpose of the Audit:
Audits serve to verify if the production and control systems are operating as intended. They help to uncover problem areas and thus, allow the timely correction of issues. Regular audits help to provide confidence that the organization is functioning under effective control. Audits performed in problem situations such as product recall or repeated market complaints are useful to identify non-compliance with cGMP and to drive initiatives to take the necessary corrective actions.
Quality audits may be of three types – internal audits or self-inspections, external audits for contract manufacturing/testing, and regulatory audits performed by regulatory bodies.
Internal audits are done by auditors within the company to assess cGMP compliance, identify problem areas and take corrective action, and prepare for audits by regulatory bodies.
External audits are carried out by a company at the sites of its vendors or contract manufacturers or testing laboratories. This type of audit helps to assess if the outside party understands the contract giver’s requirements and adheres to the quality system to reduce failure risk.
Regulatory audits are performed by regulatory bodies to check for adherence to statutory requirements. These audits are a must to ensure data quality and integrity in respect of products that seek regulatory approval.
After completion of the audit, an audit report is prepared with complete details of the areas audited, and the deficiencies observed. The report also suggests which corrective actions are required to remove problem areas, and for improvement of the quality system.
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