Performing cGMP Compliance Audit of products, processes, and systems is important to ensure that a cGMP-licensed manufacturing site and its suppliers are assessed, reviewed, and evaluated for compliance to current cGMP regulation, other market regulations, and site quality policies and procedures, with emphasis on the company’s own quality manual. Health Canada or other regulatory agencies will suspend any non-cGMP compliance site operation.
The severe consequences of cGMP violations include loss of revenues, loss of license, shutdown of manufacturing facility, seizure of products, recall of products, and competitive disadvantage, which are all very costly.
A cGMP Compliance Audit is an evaluation tool that can:
- Assess site cGMP practices to verify that required systems and controls are in place and in compliance with cGMP regulations
- Verify if site policies and procedures are being followed
- Provide site management with information regarding the level of compliance at the site and suppliers
- Facilitate early detection of any problem/discrepancy
- Help determine the depth of any identified problem/discrepancy
- Investigate and determine the root cause of any problem/discrepancy
- Recommend approval and certification of a supplier
The benefits of a cGMP Compliance Audit include:
- Ensuring that company customers receive products of acceptable quality, efficacy, and safety
- Continually improving cGMP systems and potentially transferring the best practices across the corporation
- Identifying, eliminating, and preventing problems early in the design and life of a process or system, through pro-action
- Decreasing the number of discarded, recalled, and reworked lots
- Decreasing the number of customer complaints