The purpose of study is to validate process of Rifampin 150mg and Isoniazid 75mg tablet and to create a robust formulation. The critical process parameter was identified with the help of optimization batches of process capability and evaluated by challenging specification. Three process validation batches of same size, manufacturing process, equipment & validation criteria was taken. The critical parameter involved in sifting, dry mixing, preparation of granulating agent, wet mixing, wet milling, drying, sizing, lubrication and compression stages were identified and evaluated. The outcome indicated that this process validation data provides high degree of assurance that manufacturing process produces product meeting its predetermined specifications and quality attributes.

The study was aimed to characterize protransfersome gel as TDDS of ketoprofen for effective and sustain deliver of drug. The various formulation parameters were optimized by preparing 9 formulations using Sodium cholate as edge activator. All protransfersome formulations were characterized and found that, in physical appearance protransfersome gel was Yellowish semisolid compact mass and the mean particle size of transfersome varied from 1027-1209 nm. TEM micrographs transfersome suspension showed that the vesicles have a uniform spherical shape with a smooth surface. The formulation PTC3-I have higher rate to produce transfersome than all formulations (10.331±0.221) X 103 . Formulations with cholesterol have good entrapment capacity and formulations with isopropanol have a little advantage of higher entrapment in comparison with others either with butanol or ethanol. Release rate study through cellophane membrane indicate that the % cumulative release in 48 hr was found ranging in 34%-64%, PTdC3-I formulation has shown highest percentage release.

Gas chromatography–mass spectrometry (GC-MS) is a method that combines the features of gas-liquid chromatography and mass spectrometry to identify different substances within a test sample. Analytical methods development and validation play important roles in the discovery, development and Manufacture of pharmaceuticals. Method development is the process of proving that an analytical method is acceptable for use to measure the concentration of an API in a specific compounded dosage form which allow simplified procedures to be employed to verify that an analysis procedure, accurately and consistently will deliver a reliable measurement of an active ingredient in a compounded preparation. The analytical method validation is essential for analytical method development and tested extensively for specificity, linearity, accuracy, precision, range, detection limit, quantization limit, and robustness. In summary, analytical method development and validation allows to confirm that an accurate and reliable potency measurement of a pharmaceutical preparation can be performed.

A Drug Master File is a confidential document used to provide detailed information about facilities, processes or articles used in the manufacturing process, packaging and storing of one or more human drug. The Drug Master File may be utilized either by the holder who establishes the file, or by one or more additional parties in support of their application. The Drug Master File filing allows a firm to protect its intellectual property from its partner while complying with regulatory requirements for disclosure of processing details. The review includes various types of Drug Master Files, the important aspects in filing and processing.