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Regulatory & Compliance

Internal Compliance

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 as well as IPEC and USP “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 logistics, warehousing/material handling, 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.
  • Quality Agreements in place with all Rochem represented manufacturers.
  • Fully GMP compliant and FDA registered product distribution warehouse located at our Hauppauge, New York headquarters.
  • Qualified third party product distribution warehouses and transportation channels.
  • Rochem International Inc. has been FDA inspected as well as audited by several multinational organizations for cGMP compliance.