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  • Pharmaceutical Validation: A Review
  • Photo Swati Jagtap* Photo P. B. Jadhav Photo Vinod Bairagi

  • 1Department of Pharmaceutical Quality Assurance, K.B.H.S.S. Trust Institute of Pharmacy, Malegaon Camp, Nashik.
    2Department of  Pharmacology, K.B.H.S.S. Trust Institute of Pharmacy, Malegaon Camp, Nashik.
     

Abstract

The practice of validating documentation that demonstrates a process will consistently result in a product that meets expectations is known as validation. Validation studies, according to GMP, are an essential component of GMP; they must be carried out in accordance with predetermined protocols. Process, testing, and cleaning are the bare minimum that need to be validated in order to establish control procedures that monitor output and validate manufacturing processes that might be causing variability in drug products. One of the key components in obtaining and preserving the final product's quality is validation. The accuracy, sensitivity, specificity, and repeatability of the test procedures used by the companies are provided by the validation research, which must be established and recorded. The method used in the pharmaceutical business to increase the dosage form's quality and safety is called process validation. According to cGMP, process validation is a crucial component of quality assurance. Together, validation and quality assurance will guarantee the product's complete quality. Process validation is essential to the pharmaceutical manufacturing process because it provides a high level of assurance and proof that the procedure is producing consistent results, meaning the necessary specifications have been met with accuracy. This article aims to provide a general overview and introduction to validation in the pharmaceutical business.

Keywords

Validation, Pharmaceutical Industry, Quality Assurance, GMP.

Reference

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Photo
Swati Jagtap
Corresponding author

Department of Pharmaceutical Quality Assurance, K.B.H.S.S. Trust Institute of Pharmacy, Malegaon Camp, Nashik.

Photo
P. B. Jadhav
Co-author

Department of Pharmaceutical Quality Assurance, K.B.H.S.S. Trust Institute of Pharmacy, Malegaon Camp, Nashik.

Photo
Vinod Bairagi
Co-author

Department of  Pharmacology, K.B.H.S.S. Trust Institute of Pharmacy, Malegaon Camp, Nashik.

Swati Jagtap, P. B. Jadhav, Vinod Bairagi, Pharmaceutical Validation: A Review, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 1, 399-409. https://doi.org/10.5281/zenodo.10531821

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