Volume No. :   6

Issue No. :  3

Year :  2016

ISSN Print :  2231-5705

ISSN Online :  2231-5713


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An Overview of Validation and Basic Concepts of Process Validation: Quality Assurance View Point



Address:   Abdul Saleem Mohammad1*, Swetha Devidi2, Nikhat Fatima1, Humera Badar1, Syeda Saba Sulthana1, Mohammad Akthar Sulthana3, Nuha Rasheed4
1Department of Pharmaceutical Analysis and Quality Assurance, St. Mary’s Pharmacy College, Deshmukhi (V), Pochampally (M), Behind Mount Opera, Nalgonda (Dist)-508284, Telangana, India.
2Department of Pharmaceutical Chemistry, St. Mary’s Pharmacy college, Deshmukhi (V), Pochampally (M), Behind Mount Opera, Nalgonda (Dist)-508284, Telangana, India.
3Vivekananda Group of Institutions (Pharmacy Department), Near Ramoji Film City, Ranga Reddy District, Hyderabad, Telangana, 501511.
4Assistant Professor, Department of Pharmaceutics, Nizam Institute of Pharmacy, Near Ramoji Film City, Pochampally (Mandal), Deshmukhi Village - 508284, Nalgonda Dist. Telangana
*Corresponding Author
DOI No:

ABSTRACT:
Quality is the primordial intention to any pharmaceutical industry and its products manufactured. The current interest in the pharmaceutical industry is to obtain best quality. Acquainted with a practice that puts us in common and routine convention ensured to deliver a quality that sounds globally in terms of a spoken quality is on the dais of pharmaceutical arena. Validation is the mean of catering enormous benefits to even more than the acceptable quality level which in the global standard scale. Validation is the art of designing and practicing the designed steps alongside with the documentation. Validation and quality assurance will go hand in hand, ensuring the through quality for the products. 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. 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 additionally a view of validation against the quality assurance, drug development and manufacturing process has been discussed.
KEYWORDS:
Quality, Validation, Types of validation, Process Validation, Protocol, Regulatory basis, Master plan.
Cite:
Abdul Saleem Mohammad, Swetha Devidi, Nikhat Fatima, Humera Badar, Syeda Saba Sulthana, Mohammad Akthar Sulthana, Nuha Rasheed. An Overview of Validation and Basic Concepts of Process Validation: Quality Assurance View Point. Asian J. Pharm. Tech. 2016; 6 (3): 169-176.
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