cGMP Compliance Audit must be performed on a regular basis to ensure that systems are in control and in compliance. The cGMP-licensed facility QA management must create specific standard operating procedure (SOP) for the cGMP Compliance Audit. This SOP defines the frequencies and timeframe for performing routine cGMP Compliance Audit of the facility, supply chain, and contract operations.
In cGMP regulation, each manufacturer is required to have a self inspection program in place for verifying compliance with the current CGMP regulation. Some manufacturers do the minimum; they perform an internal audit annually. Others implement comprehensive audit schedules on a more frequent basis. Sometimes, “for-cause” audits are performed upon request in response to compliance issues.
In closing, each cGMP Compliance Audit is a fact-finding exercise that provides information to management for awareness and corrective action. Each Compliance Audit that is conducted must be based on facts. Auditors are fact finders! The Auditors verify that a cGMP-licensed facility comply with current cGMP regulation. All audit observations must be able to cross reference the cGMP regulations and current industry standards.
Remember, it is management’s responsibility to take appropriate action based on the audit information. The secrets to success at any cGMP Compliance Audit include being well prepared, having good audit management, having a good auditing team, and having site management support.
