The FDA requires that suppliers of critical materials be monitored and regularly evaluated. This responsibility falls primarily on the user of the materials to ensure quality conformance at the point of use. But supplier management is more than just a requirement, it’s also a smart business practice that can prevent costly procurement mistakes.
We offer supplier quality management services that conform to your procedures and ensure that a supplier’s materials, processes and tests meet stated specifications and regulatory requirements. Our compliance experts can monitor supplier performance by providing the following services:
Supplier site audits
Supplier performance reviews based on collected data
New supplier approval processes
Laboratory Compliance Auditing
Quality measures in manufacturing and laboratory operations can sometimes be overlooked – especially in small to medium sized companies. Effective programs for calibration, validation and maintenance are not established overnight and require vigilance to ensure consistent compliance. Don’t let compliance get side tracked. We offer auditing and consulting services to help identify compliance issues before an inspector does. Our experts provide an objective analysis of your quality system to ensure it complies with predicate rules and make recommendations for improvement.
Our consults can inspect entire operations or specific areas to provide GMP compliance, including:
Manufacturing and packaging operations
Calibration and maintenance programs
Product and process specifications
Batch and test records
Equipment vendor compliance including Factory and Site Acceptance Tests (FAT and SAT)