PROCESS VALIDATION: AN OVERVIEW

Authors

  • Ujjwal Nautiyal Himachal institute of Pharmacy, Paonta Sahib, (H.P), India
  • M. Senthil Kumar Himachal institute of Pharmacy, Paonta Sahib, (H.P), India.
  • Vikas Verma Himachal institute of Pharmacy, Paonta Sahib, (H.P), India
  • Chandra Kant Himachal Institute of Pharmacy, Paonta Sahib (H.P),India
  • Rupinder Singh Himachal institute of Pharmacy, Paonta Sahib, (H.P), India

DOI:

https://doi.org/10.21276/apjhs.2014.1.1.7

Keywords:

Validation, Master plan, Stages, Types

Abstract

Process Validation emphasizes 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. It has always been known that facilities and processes involved in pharmaceutical production impact significantly on the quality of the products. The processes include raw material and equipment inspections as well as in-process controls. Process controls are mandatory in good manufacturing practice (GMP).

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Author Biographies

Ujjwal Nautiyal, Himachal institute of Pharmacy, Paonta Sahib, (H.P), India

Department of Pharmacy

M. Senthil Kumar, Himachal institute of Pharmacy, Paonta Sahib, (H.P), India.

Department of Pharmacy

Vikas Verma, Himachal institute of Pharmacy, Paonta Sahib, (H.P), India

Department of Pharmacy

Chandra Kant, Himachal Institute of Pharmacy, Paonta Sahib (H.P),India

Department of Pharmacy

Rupinder Singh, Himachal institute of Pharmacy, Paonta Sahib, (H.P), India

Department of Pharmacy,

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Published

2014-03-30

How to Cite

Ujjwal Nautiyal, M. Senthil Kumar, Vikas Verma, Chandra Kant, & Rupinder Singh. (2014). PROCESS VALIDATION: AN OVERVIEW. Asian Pacific Journal of Health Sciences, 1(1), 40–47. https://doi.org/10.21276/apjhs.2014.1.1.7

Issue

Vol. 1 No. 1 (2014): Vol 1 No 1 (2014): | Jan - March 2014

Section

Table of Contents

License

Asian Pacific Journal of Health Sciences applies the Creative Commons Attribution (CC-BY) license to published articles. Under this license, authors retain ownership of the copyright for their content, but they allow anyone to download, reuse, reprint, modify, distribute and/or copy the content as long as the original authors and source are cited. Appropriate attribution can be provided by simply citing the original article.

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