Abstract

PROCESS VALIDATION: A REVIEW

*Dhananjay Shinde, Devyani Mahajan, Vaibhav Dound and Sneha Lohar

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Abstract

When we talk about the pharmaceutical products, „Quality‟ is the only thing that must be taken in consideration. We can define Quality by so many ways. As per Crosby quality can be define as “Conformance to Requirement”. As per Juran quality can be define as “Fitness to Use”. As per Deming quality can be define as “Meet and Exceed Customer‟s Need and Expectation”. As per Ishikawa quality can be define as “Continuous Improvement”. Validation is program which is implemented in the area of quality assurance in order to build and improve quality of the product. During manufacturing of various dosage forms, various steps are involve in the manufacturing process and validation of this process is called as „Process Validation‟. The data which is recorded during manufacturing process is data is use in the process validation. Quality building is continuous process and it takes multidirectional efforts. Process validation gives assurity about process capability to produce consistently quality product. As per current Good Manufacturing Practices (cGMP) validation is part of quality assurance and both of these are contributing to ensure quality of the product. In this work general introduction and overview of process validation is given.

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