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US FDA Regulatory Compliance and Testing

The company’s in-house QA/QC department is operated by a team of accredited scientists who pride themselves on adhering and complying    with a list of international quality standards:

  • US FDA  (US Food and Drug Administration)
  • NSF GMP  (NSF accredited for cGMP compliance
  • Dietary Supplement 21 CFR part 111 Compliance
  • HACCP Plans
  • NABL  (National Accreditation Board of Testing & Calibration Laboratories)
  • DCGI  (Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy)
  • GLP  (Good Laboratory Practices)
  • WHO GMP (World Health Organization Good Manufacturing Practices)
  • ISO 9001:2008  (International Organization for Standardization)
  • ISO/IEC 17025:2005 (International Organization for Standardization)
  • ISO 14001 (International Organization for Standardization)
  • ISO 18001 (International Organization for Standardization)
  • FSSAI (Food Safety and Standards Authority of India)

The fully equipped and modern laboratories offer quantification of dietary supplements as well as:

  • Vitamin and amino analysis on HPLC
  • Mineral analysis on ICP-OES, On ICP-MS
  • Botanical identification/standardization – HPLC, GC, UV
  • Endotoxin testing – LAL method
  • Heavy Metal analysis on ICP-MS
  • Testing of Aflatoxins – B1, B2, GI and G2 by HPLC
  • Pesticides residue analysis – USP, AOAC, EPA on GC and HPLC
  • Microbiological contamination testing
  • Irradiation and radioactive testing on PSL
  • Residual solvent analysis according to ICH guidelines – Q3 on GC

Additionally, the laboratories at US Pharma Lab India are commercially approved by the DCGI (Drugs Controller General of India) and the Department of AYUSH (Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy).  US Pharma Lab India offers:

  • NABL accredited laboratories for chemical/microbiological testing
  • Analytical division assessed by NABL and compliant with ISO/IEC 17025:2005
  • Government of India approved R&D department
  • Laboratories approved by DGCI for pharmaceutical testing
  • Analytical division certified as per GLP from Government of Rajasthan

By effectively managing the QA/QC standards for compliance, US Pharm Lab is the right partner for those who need the best in formulation science.