BioZone Quality System

We are truly care-full with your products: BioZone Labs conducts all manufacturing under strict quality assurance and control standards per Good Manufacturing Practice requirements and guidelines as mandated by the U.S. Food and Drug Administration.

To ensure consistent production of safe, effective products, our BQS covers all aspects of the process:

  • Facilities and Equipment
  • Laboratory Control
  • Material Control
  • Production Packaging/Labeling

BioZone maintains strict compliance with current cGMPs 21 CFR Parts 111, 210 and 211 and is regularly inspected by the FDA and the California Department of Public Health.

In-House Analytical and Micro Laboratories

Biozone conducts physical, chemical and formal stability studies in our fully-equipped Analytical Laboratory, in accordance with ICH guidelines. Our scientists develop methods to determine identity, purity, potency and composition of raw materials and in-process/finished products; Customers with existing analytical test methods may easily transfer those to our lab. We conduct stability studies using both real time (25°C/60% RH) and accelerated conditions (40°C/75% RH).

Analytical Capabilities

BioZone’s laboratories conform to the United States Pharmacopeia-National Formulary pharmacopeial standards, cGMP regulations and applicable ICH guidance.

  • High-Performance Liquid Chromatography (HPLC)
  • Atomic Absorption Spectroscopy (AA)
  • Fourier Transform Infrared Spectroscopy (FT-IR)
  • Viscosity
  • Specific Gravity
  • Karl Fischer Moisture Content Analysis
  • pH Determination
  • Total Organic Carbon (TOC)
  • Method Development and Validation
  • Gas Chromatography (GC)
  • UV-Visible Spectroscopy (UV-Vis)
  • Refractive Index (RI)
  • Melting Point
  • Specific Rotation
  • Identity testing by USP methods
  • Conductivity
  • Stability Testing
  • Method Transfer

Microbiological Capabilities

Product testing/validation for the absence of objectionable microorganisms is supported in our in-house Microbiological Laboratory, saving development time and ensuring additional control.

  • Antimicrobial Effectiveness Testing by USP (51)
  • Microbial Enumeration Testing by USP (61 Plate Count Methods)
  • Testing for Specified Microorganisms by USP (62)
  • Microbiological Challenge Testing
  • Microbiological Media Qualification
  • Basic Identification Testing:
    1. Gram Staining
    2. Enzymatic Testing (Oxidase, Coagulase, Catalase)
    3. Growth on Selective and Differential Media

BioZone Registrations and Licenses

  • Registered as a Drug Establishment with the FDA
  • Licensed by the U.S. Drug Enforcement Administration (DEA) to handle controlled substances
  • Licensed as a Drug Manufacturer with the State of California
  • Registered as a Processed Food Manufacturer with the State of California

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