PT  - JOURNAL ARTICLE
AU  - Fourman, Gary L.
TI  - Start-Up of Sterile Products Production in International Facilities
DP  - 1983 Jul 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 132--137
VI  - 37
IP  - 4
4099  - http://journal.pda.org/content/37/4/132.short
4100  - http://journal.pda.org/content/37/4/132.full
SO  - PDA J Pharm Sci Technol1983 Jul 01; 37
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.