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Journal :   Research Journal of Pharmacy and Technology

Volume No. :   7

Issue No. :  9

Year :  2014

Pages :   1081-1090

ISSN Print :  0974-3618

ISSN Online :  0974-360X


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An Overview of Concept of Pharmaceutical Validation



Address:   Saroj Kumar Raul*, Gopal Krishna Padhy, Anjan Kumar Mahapatra, Soudamini Alekha Charan
Maharajah’s College of Pharmacy, Phoolbaugh, Vizianagaram, Andhra Pradesh India
*Corresponding Author
DOI No: Not Available

ABSTRACT:
Drugs are the most important elements in healthcare and must be manufactured to the highest quality levels. Multiple views on obtaining such quality are the current interest in the pharmaceutical industry. Process validation performs this task ensuring that the process does what it purports to do. The process validation is establishing documented evidence which provides high degree on assurance that a specific process consistently produced a product meeting its predetermined specifications and quality characteristic. Validation is the art of designing and practicing the designed steps alongside with the documentation. Process validation emphasize on process design elements and maintaining process control during commercialization and communicate that process validation is an ongoing program and align process validation activities with product lifecycle. According to GMP validation studies are essential part of GMP and required to be done as per predefined protocols. Process validation also emphasizes the role of objective measures and statistical tools and analyses and emphasizes knowledge, detection, and control of variability and gives assurance on consistent of quality/productivity throughout life cycle of product. Thus the validation is an essential part of the quality assurance. Lending importance to validation is increasingly profound in recent years. Hence, an emphasis made on this review that gives a detailed, overview of process validation concept
KEYWORDS:
Pharmaceutical Validation, Quality Assurance, Protocol, Validation Master Plan, Revalidation.
Cite:
Saroj Kumar Raul, Gopal Krishna Padhy, Anjan Kumar Mahapatra, Soudamini Alekha Charan. An Overview of Concept of Pharmaceutical Validation. Research J. Pharm. and Tech. 7(9): Sept. 2014 Page 1081-1090.
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