RT Journal Article
SR Electronic
T1 Start-Up of Sterile Products Production in International Facilities
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 132
OP 137
VO 37
IS 4
A1 Gary L. Fourman
YR 1983
UL http://journal.pda.org/content/37/4/132.abstract
AB 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.