Journal of Pharmaceutical Research

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Functional Overview of Process Validation of Tablets - A Critical Review


Affiliations
1 Department of Quality Assurance, Krupanidhi College of Pharmacy, #12/1, Chikkabellandur, Carmelaram Post, Varthur Hobli, Bangalore - 560035, KA, India
 

Purpose: Validation is a main tool in achieving and maintaining the quality and safety of the final product as per cGMP(current Good Manufacturing Practice). The purpose of this present work is to give introduction, general overview and how to plan, develop, execute process validation of pharmaceutical manufacturing process especially tablet manufacturing process.

Approach: When we consider any product, quality is always an imperative pre requisite hence a highest quality levels must be included in the manufacturing of the drug.

Findings: To assure the identity, purity, safety, efficacy and also maintaining the quality of final product process validation is the key element. Three consecutive batches were considered to execute the process validation activity.

Conclusion: Process validation is a major requirement of cGMP's regulation. Process validation is a key element to maintain product quality, safety, identity and efficacy.


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  • Functional Overview of Process Validation of Tablets - A Critical Review

Abstract Views: 183  |  PDF Views: 66

Authors

Manasa S. Reddy
Department of Quality Assurance, Krupanidhi College of Pharmacy, #12/1, Chikkabellandur, Carmelaram Post, Varthur Hobli, Bangalore - 560035, KA, India
R. Chandramouli
Department of Quality Assurance, Krupanidhi College of Pharmacy, #12/1, Chikkabellandur, Carmelaram Post, Varthur Hobli, Bangalore - 560035, KA, India

Abstract


Purpose: Validation is a main tool in achieving and maintaining the quality and safety of the final product as per cGMP(current Good Manufacturing Practice). The purpose of this present work is to give introduction, general overview and how to plan, develop, execute process validation of pharmaceutical manufacturing process especially tablet manufacturing process.

Approach: When we consider any product, quality is always an imperative pre requisite hence a highest quality levels must be included in the manufacturing of the drug.

Findings: To assure the identity, purity, safety, efficacy and also maintaining the quality of final product process validation is the key element. Three consecutive batches were considered to execute the process validation activity.

Conclusion: Process validation is a major requirement of cGMP's regulation. Process validation is a key element to maintain product quality, safety, identity and efficacy.


References