Pharmaceutical Process Validation: A Review

Authors

  • C Karthick PG Student, Department of Pharmacy, Annamalai University, Chidambaram, Tamil Nadu, India
  • K Kathiresan Associate Professor, Department of Pharmacy, Annamalai University, Chidambaram, Tamil Nadu, India

Abstract

Pharmaceutical industries are in now their peak period. There is a need to ensure that pharmaceutical process validations are being done so well and results we obtain is reproducible. Results simply ensure product items consistency. These validations must be done in such a way that final product satisfies all of requirements, is very necessary in pharmaceutical field. Whatever will be the product or whatever will be the protocols, important prerequisite is Quality. Process validation signifies the values of analytical tools, analytical procedures, objective measures and it gives attention towards Knowledge, Detection and control on variabilities So as to assure quality throughout the life cycle of product. The object of this article is to explain the enormous utilities of process validation and their need, methods. This process validation assures the delivery of product just like predetermined. Without the process validation one cannot expect the precision in results.

Keywords: PV- Process validation, CV- Concurrent validation, RV- Retrospective validation

Keywords:

PV- Process validation, CV- Concurrent validation, RV- Retrospective validation

DOI

https://doi.org/10.22270/jddt.v12i1-S.5316

Author Biographies

C Karthick, PG Student, Department of Pharmacy, Annamalai University, Chidambaram, Tamil Nadu, India

PG Student, Department of Pharmacy, Annamalai University, Chidambaram, Tamil Nadu, India

K Kathiresan, Associate Professor, Department of Pharmacy, Annamalai University, Chidambaram, Tamil Nadu, India

Associate Professor, Department of Pharmacy, Annamalai University, Chidambaram, Tamil Nadu, India

References

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Published

2022-02-15
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How to Cite

1.
Karthick C, Kathiresan K. Pharmaceutical Process Validation: A Review. J. Drug Delivery Ther. [Internet]. 2022 Feb. 15 [cited 2026 May 31];12(1-S):164-70. Available from: https://jddtonline.info/index.php/jddt/article/view/5316

How to Cite

1.
Karthick C, Kathiresan K. Pharmaceutical Process Validation: A Review. J. Drug Delivery Ther. [Internet]. 2022 Feb. 15 [cited 2026 May 31];12(1-S):164-70. Available from: https://jddtonline.info/index.php/jddt/article/view/5316