TY - JOUR T1 - Start-Up of Sterile Products Production in International Facilities JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 132 LP - 137 VL - 37 IS - 4 AU - Gary L. Fourman Y1 - 1983/07/01 UR - http://journal.pda.org/content/37/4/132.abstract N2 - The major elements of smoothly starting sterile products operations in international facilities are presented by using recent start-up experiences in Taiwan and Korea as models. The importance of getting a start-up team into the facilities as soon as possible, involving the appropriate people who will work together, and coordinating the team’s trips to the new facility are discussed. Recommendations for writing start-up and validation manuals, testing equipment, training personnel, and implementing documentation systems are given. Lastly, practice batches that should be made before starting routine production are discussed. ER -