Custom Processing Services:
- is committed to the requirements of the ISO 9001 quality system;
- will strive to meet or exceed our customer’s expectations and requirements;
- will continually improve the effectiveness of the quality management system;
- is cGMP (current Good Manufacturing Practices) compliant;
- has an established HACCP (Hazard Analysis Critical Control Point) system.
cGMP are FDA regulated requirements to ensure that the products produced meet specific requirements for identity, strength, quality, and purity. Put another way, Good Manufacturing Practices are standard guidelines set by the FDA to ensure all parts of drug development are carried out in safe and quality processes, to avoid contamination and ensure repeatability.
HACCP is a quality management system (based on seven principles) which identifies and evaluates points during production (starting with receiving and ending with shipping) in order to set up measures and control biological, chemical, and physical hazards to ensure product safety. The seven principles of HACCP are:
- Conduct a hazard analysis.
- Identify critical control points.
- Establish critical limits for each critical control point.
- Establish critical control point monitoring requirements.
- Establish corrective actions.
- Establish record keeping procedures.
- Establish procedures for verifying the HACCP system is working as intended.