Preperation of drug master file (CTD) for ornidazole 250 mg film coated tablete

In this work, ornidazol is a group of nitroimidazol which has effects of bacterisid, tricomonosid and amebisid was developed suitable formulation and after pilot measure production, final product analyzis was done.P group whicih is a final product file, in P part, we analyzised 3.modül which include knowledge of chemical, pharmaceutical and biololgical .3.2.P DRUG PRODUCT (NAME, DOSAGE FORM)3.2.P.1 Description and Composition of the Drug Product (name, dosage form)3.2.P.2 Pharmaceutical Development (name, dosage form)3.2.P.2.1 Components of the Drug Product (name, dosage form)3.2.P.2.1.1 Drug Substance (name, dosage form)3.2.P.2.1.2 Excipients (name, dosage form)3.2.P.2.2 Drug Product (name, dosage form)3.2.P.2.2.1 Formulation Development (name, dosage form)3.2.P.2.2.2 Overages (name, dosage form)3.2.P.2.2.3 Physicochemical and Biological Properties (name, dosage form)3.2.P.2.3 Manufacturing Process Development (name, dosage form3.2.P.2.4 Container Closure System (name, dosage form)3.2.P.2.5 Microbiological Attributes (name, dosage form) 3.2.P.2.6 Compatibility (name, dosage form)3.2.P.3 Manufacture (name, dosage form) 3.2.P.3.1 Manufacturer(s) (name, dosage form) 3.2.P.3.2 Batch Formula (name, dosage form) 3.2.P.3.3 Description of Manufacturing Process and Process Controls (name, dosage form)3.2.P.3.4 Controls of Critical Steps and Intermediates (name, dosage form) 3.2.P.3.5 Process Validation and/or Evaluation (name, dosage form)3.2.P.4 Control of Excipients (name, dosage form)3.2.P.4.1 Specifications (name, dosage form)3.2.P.4.2 Analytical Procedures (name, dosage form) 3.2.P.4.3 Validation of Analytical Procedures (name, dosage form) 3.2.P.4.4 Justification of Specifications (name, dosage form) 3.2.P.4.5 Excipients of Human or Animal Origin (name, dosage form) 3.2.P.4.6 Novel Excipients (name, dosage form)3.2.P.5 Control of Drug Product (name, dosage form)3.2.P.5.1 Specification(s) (name, dosage form)3.2.P.5.2 Analytical Procedures (name, dosage form) 3.2.P.5.3 Validation of Analytical Procedures (name, dosage form) 3.2.P.5.4 Batch Analyses (name, dosage form) 3.2.P.5.5 Characterisation of Impurities (name, dosage form) 3.2.P.5,6 Justification of Specification(s) (name, dosage form)3.2.P.6 Reference Standarts or Materials (name, dosage form) 3.2.P.7 Container Closure System (name, dosage form) 3.2.P.8 Stability (name, dosage form)3.2.P.8.1 Stability Summary and Conclusion (name, dosage form)3.2.P.8.1.1Stability Conditions3.2.P.8.1.1.1Lond Term Stability3.2.P.8.1.1.2Short Term Stability3.2.P.8.1.1.3Tested Parameters3.2.P.8.1.1.4Test Methods3.2.P.8.1.2Conclusion3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment (name, dosage form)3.2.P.8.3 Stability Data (name, dosage form)Finally, substances and explanations necessary for the above-mentioned tests were made according to ICH wih method validations. Module 3 P section of this compound is presented.Key Words: CTD, Ornidazole, Drug Master File, Module 3.