TY - JOUR T1 - An FDA Update on GMP’s For Aseptic Processing JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 154 LP - 157 VL - 39 IS - 4 AU - Edmund M. Fry Y1 - 1985/07/01 UR - http://journal.pda.org/content/39/4/154.abstract N2 - On February 1, 1985, FDA published a Notice of Availability of a draft guideline on aseptic processing of sterile drug products. The draft guideline, dated January 1985, provides guidance on acceptable ways to comply with several CGMP regulations governing aseptic processing, such as 21 CFR 211.42 (design and construction features), 211.84 (testing of components, containers and closures), 211.113 (control of microbiological contamination/validation), and 211.167 (sterility test requirements). The draft guideline was prepared in-house and has not been made available before to persons outside FDA. The guideline covers a number of areas in which wide variation in compliance has been observed in the industry, including air quality specifications and monitoring in processing areas, sterile media fills, and investigation of sterility test failures. Comments from the affected industry, such as that represented by the Parenteral Drug Association, will be carefully considered, and incorporated into the guideline if appropriate. We at FDA desire to publish a final guideline that represents current good manufacturing practice and will have a positive impact on industry compliance. ER -