QM: 8.2.2 Internal Audit

8.2.2

Internal Audit

8.2.2 Internal Audit

Internal audits are conducted at planned intervals to determine conformance to planned arrangements, to the requirements to ISO 9001:2008 standard, applicable regulatory requirements (Drug and Cosmetic Act and Rules, WHO, FDA, EU etc), GMP and company’s established Quality Management System. In addition, internal audits are conducted to ascertain whether the QMS is effectively implemented and maintained and to identify opportunities for continual improvements.

An audit program is defined and implemented, and identifies an audit schedule based on the importance of the areas to be audited, as well as the results of previous audit. The audit criteria, scope, frequency, methods, responsibilities and requirements for planning and conducting audits, and for reporting and maintaining results, are defined and documented in the internal audit procedure. 

The audit program includes:

Audits will be carried out against documented procedures and regulatory requirements on a yearly schedule

The schedule will be set based on importance of area to be audited (every activity and area is subject to an internal quality audit at least once a year)

Scope of the audit should be defined

Trained auditors will be selected independent of the area to be audited

Follow-up corrective actions and results of these audits will be documented and reported

Corrective and preventive actions are reviewed by the Quality department and follow-up audits are conducted, as appropriate

Records will be maintained of the audit and reviewed during the next audit scheduled for effectiveness

Managers and/or supervisors of the department being audited ensure that required actions (investigation and CAPA) from audit results are completed without undue delay. These actions should eliminate the nonconformities and their causes.

Results of the internal audits are evaluated and reviewed to verify the effectiveness and are used as inputs to the Management Review to ensure suitability of the Quality System.