Regulatory Services

Auditing

Quality systems for manufacturing and laboratory operations are easily overlooked in small to medium sized companies. Effective programs for calibration, validation and maintenance are not established overnight and require vigilance to ensure consistent compliance.

To help you avoid getting side tracked by growth or change, QSP can provide third party audits to identify compliance issues before the FDA or a customer does. Our experts help ensure that you’re meeting the requirements of your quality system or see how far you need to go to meet it.

Our quality experts can inspect complete facilities or specific areas to provide an objective analysis of GMP compliance.

We can inspect:

• Manufacturing and packaging operations
• Laboratory operations
• Validation programs
• Calibration and maintenance systems
• Suppliers
• Product and process specifications
• Batch and test records
• Equipment vendors including Factory and Site Acceptance Tests (FAT and SAT)
• Facility and Utility Qualification