Abstract

R. Swetha Sri*, Dr. K. Bhavya Sri and P. Soundarya

ABSTRACT

PET drugs are radioactive drugs injected into patients that create images that can be read with a special camera called a PET scanner. PET images show the chemical functioning of an organ or tissue. PET drugs contain a very small amount of radioactive material, similar to the material used in other diagnostic procedures. One of the distinctive properties of PET drugs is that, because of their short half-life, they must be administered to patients within minutes or hours of being produced. Current good manufacturing practice is a minimum manufacturing/production standard that ensures the drug meets the requirements of safety and has the identity strength, quality, and purity it is supposed to have. CGMP covers items such as control of ingredients used to make drugs, production procedures and controls, recordkeeping, quality system, and product testing. 21 CFR parts 210 and 211 contain the CGMP for non-PET drugs, while proposed 21 CFR part 212 will contain CGMP requirements for PET drugs.