DO YOU NEED DIRECTION? LET CSA BE YOUR GUIDE!
The FDA requires not only material monitoring for quality and effectiveness, but also documentation of regularly scheduled evaluations and quality standards. This can leave business owners in a bind, leading to a lack of documentation as required and at times, costly procurement mistakes. With CSA’s experience, we can guide your business and make recommendations on what steps are necessary for compliance, as well as provide services to get you there.
GMP COMPLIANCE CONSULTATION INSPECTION INCLUDES:
- Manufacturing and packaging operations
- Validation programs
- Laboratory operations
- Calibration and maintenance programs
- Pre-inspection assessment
- Product and process specifications
- Batch and test records
- Equipment vendor compliance including Factory and Site Acceptance Tests (FAT and
SUPPLIER QUALITY MANAGEMENT
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.
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.