FDA Standards
FDA Specifications for Environmental Test Chambers
Food and Drug Administration (FDA)
FDA is a United States Department of Health and Human Services federal agency. Their responsibilities include promoting and protecting public health the the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical medications, vaccines, biopharmaceuitcals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal foods and veterinary products. The organization is headed by the Commissioner of Food and Drugs, who is appointed by the President.
CGMPs
Current Good Manufacturing Practices followed by pharmaceutical and biotech firms to ensure that the products produced meet specific requirements for identity, strength, quality and purity.
Q1A(R2)
Stability Testing of New Drug Substances and Products provides recommendations on stability testing protocols, including temperature, humidity, and trial duration for climatic zones. The purpose of stability testing is to provide evidence on how the quality of a drug substance or product varies with time under the influence of a variety of environmental factors.