Abstract

PROCESS VALIDATION OF SIMVASTATIN 20MG TABLETS

Highlights

  • The prime objective of any pharmaceutical plant is to manufacture products of requisite attribute and quality consistently, at the lowest possible cost

  • Validation studies have been conducted in the pharmaceutical industry for a long time, there is an ever increasing interest in validation owing to their industry’s greater emphasis in recent years on quality assurance program and is fundamental to an efficient production operation

  • Validation is a concept that has evolved in united states in 1978.The concept of validation has expanded through the years to embrace a wide range of activities from analytical methods used for the quality control of drug substances and drug products to computerized systems for clinical trials, labelling or process control, Validation is founded on, but not prescribed by regulatory requirements and is

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Summary

Introduction

The prime objective of any pharmaceutical plant is to manufacture products of requisite attribute and quality consistently, at the lowest possible cost. Prior to undertaking retrospective validation, wherein the numerical in-process and/or end-product test data of historic production batches are subjected to statistical analysis, the equipment, facilities and subsystems used in connection with the manufacturing process must be qualified in conformance with CGMP requirements. Phase 3: Validation Maintenance phase requiring frequent review of all process related documents, including validation audit reports to assure that there have been no changes, deviations, failures, modifications to the production process, and that all SOPs have been followed, including change control procedures At this stage the Validation Team assures that there have been no changes/deviations that should have resulted in requalification and revalidation.. Poonam Rana*et al /International Journal of Pharmacy & Technology Method of Collection of Data: The process validation of tablets manufacturing will include:-.

Material and Method
Wet mixing Binder addition time at
Findings
Conclusion
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