BioZone Laboratories, Inc. formulates, develops and manufactures high quality health, beauty and drug products for the cosmetic and pharmaceutical industries. All manufacturing is conducted under strict quality assurance and control standards in accordance with Good Manufacturing Practice (“cGMP”) requirements and guidelines as mandated by the U.S. Food and Drug Administration (“FDA”).
BioZone maintains a comprehensive quality system to ensure compliance with 21CFR parts 210 and 211. The BioZone Quality System consists of formal practices and standard operating procedures covering all aspects of the manufacturing process, including:
The Quality System provides for continual monitoring and evaluation of each project to assure that quality assurance and control standards are satisfied. Our goal is to ensure consistent production of safe and effective products.
Core principles of the Quality System:
The BioZone Quality System is based on the following guidance documents published by the FDA:
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.
We maintain a fully equipped analytical laboratory in which we conduct physical, chemical and formal stability studies in accordance with ICH guidelines. Our scientists are capable of developing and validating analytical methods to determine identity, purity, potency and composition of raw materials and in-process and finished products. Customers with existing analytical test methods may transfer those methods to the analytical staff in our laboratory. We conduct our stability studies at real time (25°C/60% RH) and accelerated conditions (40°C/75% RH).
We maintain a fully equipped microbiological laboratory in which we test and validate our products for the absence of objectionable microorganisms.
Our laboratories conform to the United States Pharmacopeia-National Formulary (USP-NF) pharmacopeial standards, cGMP regulations and applicable ICH guidance.