A.S. Kalykova1,2, D.V. BARINOV1, Z.B. SAKIPOVA2, L.N. IBRAGIMOVA2,
O.V. CHSHUKINA1, A.A. AZEMBAYEV1
1JSC “Scientific Centre for Anti-Infectious Drugs”, Almaty с., Kazakhstan,
2Kazakh National Medical University n.a. S.D. Asfendiyarov, Almaty с., Kazakhstan
VALIDATION OF MANUFACTURING PROCESS FOR ORAL DOSAGE FORM WITH IODINE ADDUCTS
Validation technology for liquid dosage forms with iodine adducts – FS-1 medical substance was carried out under the scale pilot production.
Material and methods. Studies of physical and chemical parameters of raw materials, intermediates and products were performed by spectrophotometric and titrimetric assays. The results were processed using the software “Statistica 12” and Shewhart control charts.
Results and discussions. For the validation of the technological process of FS-1 drug production were examined three manufactured successive pilot-scale batches of drug – 05251013, 06011113, 07061113 in the volume 40±2 L of each. The regulatory documents, regulating the production process was created. Comparable data on the technological parameters of the three batches was obtained and confirmed the stability of the production process of FS-1 solution intended for oral administration.
Conclusions. Thus, the transfer of technology production from laboratory to pilot model successfully carried out, which is confirmed by validation studies.
Key words: FS-1 substance, iodine adducts, validation of manufacturing process, control charts, solution per oral use.