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Quality Assurance Program

QA PROGRAM


Our compounding facility located in San Jose, CA is state-of-the-art and built to cGMP, USP, and ISO14644 standards.

United States Pharmacopeial Convention (USP) standards, including USP-797, USP-795, and USP-71, as well as state boards of pharmacy regulations.

  • Non-sterile ISO-8 Compounding laboratory certified every six months
  • ISO-8 anteroom certified every six months
  • ISO-7 buffer room certified every six months
  • ISO-7 negative pressure room certified every six months
  • ISO-5 primary engineering control certified every six months

Our state-of-the-art compounding lab includes:

  • Built-in non-viable particle monitoring
  • Built-in viable air impact monitoring
  • Alert system for monitoring of particle counts, differential pressure, temperature, relative humidity %, and all refrigerators and freezers.