Rochem’s internal
global operations are fully GMP compliant according to requirements set forth
in ICH Q7 “GMP Guide for Active Pharmaceutical Ingredients” for Pharmaceutical
distributors and IPEC “Good Distribution Practices”. This internal GMP control
includes the following:
- Global operations completely controlled by internal Standard
Operating Procedures and quality systems which include control of purchasing,
accounting, logistics, and all Regulatory/Compliance quality activities.
- Logistics procedures maintained to ensure complete traceability
of all distributed material.
- Customer change communication and quality complaint handling
systems in place.
- Fully GMP compliant and FDA registered product distribution warehouse located at our Ronkonkoma, New York headquarters.
- Qualified third party product distribution warehouses and transportation channels.
- Rochem International Inc. was last inspected by the FDA in November 2006.