A quality audit is an independent evaluation performed to review if activities are performed in a manner to complies 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 recalls or repeated market complaints are
useful to identify non-compliance with cGMP and to drive initiatives to take
the necessary corrective actions.
Audit Types:
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 take corrective
action, and prepare for audits by regulatory bodies.
External audits are carried out by a company at the
sites of its vendors 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 with respect to 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.