Madhabhai M. Patel

As per ICH guideline impurity may be defined as any component of drug product that is not the drug substance or an excipient. Now a day apart from purity profile there are an increasing essentiality of impurity profile by regulatory agency. Different regulatory agencies like ICH,USFDA, TGA, etc. work on control and identification of impurities in pharmaceutical dosage forms. To identify and characterize impurities are essential for establishing the biological safety of an pharmaceutical dosage forms. The various pharmacopoeias like IP, BP, USP, etc. were allowed certain limits of impurities in pharmaceutical dosage forms. This review article mainly focuses on various methods available to identify and characterize impurities in pharmaceutical dosage forms. Among all, the most specific techniques are NMR, MASS, GC-MS, LC-MS, HPLC-DAD-MS, LC-MS-MS, HPLC-DAD-NMR-MASS, Capillary electrophoresis, Mass and Flash chromatography. Key words: Impurities, identification, HPLC-DAD-MS.

Process validation is an important tool in modern pharmaceutical industry. Validation gives a quality proof to the product which was manufactured under specified condition and quality parameter defined by GMP. The process validation is established documented evidence which provides high degree on assurance that a specific process consistently produced a product meeting its predetermined specifications and quality characteristic. If each step of manufacturing process is validated, we can assure that the final product is of desire quality. Validation of the individual steps of the processes is called the process validation. The validation study provides the accuracy, sensitivity, specificity and reproducibility of the test. This article covers Introduction, type of validation, Phases of Process Validation, Documentation, SOP, Validation Master Plan and Validation Protocol. Validation is an integral part of quality assurance, during the formulation of any product quality has always been an important factor and therefore training is required before moving on at every step such as manufacturing material, equipment, process and procedures so that the quality of the product may be regulated.