Quality
To achieve operational excellence, Santé Laboratories is dedicated to providing high quality testing and product development services to its partners worldwide.
As a result, we meet all applicable federal regulatory requirements including current GMPs in the United States and Australia as well as expectations established by the United States Pharmacopeia, ISO/IEC 17025:2017, and AOAC International. To achieve operational excellence, all regulations and standards including those regarding controlled substances (DEA), environmental protection (EPA), and employee safety (OSHA) must be met.
Santé Laboratories Quality Assurance program includes:
- Well-defined processes written into work instructions and standard operating procedures (SOP)
- Dedicated quality assurance staff to support compliance with applicable regulatory requirements
- Current GMP training programs and internal processes for Santé Laboratories staff members
- Operational synergy between all Santé Laboratory departments
- Risk management and rigorous supplier qualification requirements
- Routine management review and internal auditing
- Highly qualified scientists to support development, analytical, and document control functions