Abstract
As per GMP process validation is very important and required part in product development. Process Validation is required for ensuring and providing the documentary evidence and also required for giving the Surety that process by which the formulation is prepared is capable of consistently producing the product of required quality and purity.
 A validated manufacturing process is one which has been proved to do what it purports on is represented to do. The proof of validation is obtained through the collection and evaluation of data, preferably, beginning from the process development phase and Continuing through the production phase. Validation necessarily includes process qualification (the qualification of materials, equipment Systems, buildings, personnel), but it also includes the control on the entire process for repeated batches or runs. This article gives a general introduction and overview about process validation in pharmaceutical manufacturing process and its importance.
 Keywords: GMP, Validation, validation manufacturing process.
Highlights
The word validation means assessment of validity or action of proving effectiveness
Quality cannot be adequately assured merely by in-process and finished product inspection or testing each step of a manufacturing process is controlled to assure that the finished product meets all quality attributes including specifications[1]
The concept of validation has expanded through the years to encompass a wide range of activities from analytical methods used for the quality control of the drug substances and drug products to computerized systems for clinical trials[2]
Summary
The word validation means assessment of validity or action of proving effectiveness. Validation is a team effort where it involves people from various disciplines of the plant. This principle incorporates the understanding that the following conditions exist: Quality, safety, and efficacy are designed or built into the product. Quality cannot be adequately assured merely by in-process and finished product inspection or testing each step of a manufacturing process is controlled to assure that the finished product meets all quality attributes including specifications[1]. Validation is a concept that has been evolving continuously since its first formal appearance in the United States in 1978. The concept of validation has expanded through the years to encompass a wide range of activities from analytical methods used for the quality control of the drug substances and drug products to computerized systems for clinical trials[2]
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