Emulgels have emerged as a promising drug delivery system for the delivery of hydrophobic drugs. The objective of the study was to prepare emulgel of mefenamic acid, a NSAID, using Carbapol 940 as a gelling agent. Mentha oil and clove oil were used as penetration enhancers. The emulsion was prepared and it was incorporated in gel base. The formulations were evaluated for rheological studies, spreading coefficient studies, bioadhesion strength, skin irritation studies, in vitro release, ex vivo release studies, anti-inflammatory activity and analgesic activity. Formulation F2 and F4 showed comparable analgesic and anti-inflammatory activity when they compared with marketed diclofenac sodium gel. So, it can be concluded that topical emulgel of mefenamic acid posses an effective anti-inflammatory and analgesic activity.

Validation is the art of designing and practicing the designed steps alongside with the documentation. Process validation emphasize on process designelements and maintaining process control during commercialization andcommunicate that process validation is an ongoing program and alignprocess validation activities with product lifecycle. Process validation alsoemphasizes the role of objective measures and statistical tools & analysesand emphasizes knowledge, detection, and control of variability and givesassurance on consistent of quality/productivity throughout life cycle of product. According to GMP, validation studies are essential part of GMP these are required to be done as per predefined protocols. The process validation is establishing documented evidence which provides high degree on assurance that a specific process consistenly produced a product meeting its predetermined specifications and quality characteristic. The validation study provide the accuracy, sensitivity, specificity and reproducibility of the test methods employed by the firms, shall be established and documented. Thus the validation is an essential part of the quality assurance. Lending importance to validation is increasingly profound in recent years.

Product quality is the mainstay of pharmaceutical industries and is derived from careful attention to a number of factors including selection of quality parts and materials, adequate product and manufacturing process design, control of the process variables, in-process and end-product testing. Process validation is an integral part of quality assurance program in industries. By validating each step of production process we can assure that the final product is of best quality. This review provides information on objectives and benefits of process validation, types of process validation, major phases in validation and regulatory aspects. Guidelines and strategy for process validation of solid dosage form are also discussed.

Validation is the important step in gaining and maintaining the quality of the final product. Validation of the individual steps of the processes is called the process validation. Different dosage forms have different validation protocols. Validation is therefore is one element of quality assurance programs and is associated with a particular process therefore word validation simply means “assessment of validity” or action of proving effectiveness. Validation thus provides a higher degree of assurance that the manufacturing process consistently meets the pre-determined specifications and the quality products output can be used to increase productivity, its consistent quality and decreasing the need for processing and market complaints of the drug product. This overview examines the need for pharmaceutical validation, the various approaches and steps involved

Validation is one of the important steps in achieving and maintaining the quality of the final product. Validation of the individual steps of the processes is called the process validation. Process validation's main objective continues to be the generation of a process which yields a product which meets predetermined quality criteria. It is an important component in the design, prototyping and manufacturing process and one, if done correctly, that can save a considerable amount of time, money and resources. End-product testing by itself does not guarantee the quality of the product. Therefore Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. Process Validation performs this task to build the quality into the product at every step. FDA has released various guidelines for process validation. This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes. FDA considers appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including active pharmaceutical ingredients.