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Contact Name
I Wayan Sudarsa
Contact Email
sudarsa@unud.ac.id
Phone
-
Journal Mail Official
globalpharmatechnology@gmail.com
Editorial Address
India
Location
Kota denpasar,
Bali
INDONESIA
Journal of Global Pharma Technology
Published by Universitas Udayana
ISSN : 09758542     EISSN : -     DOI : -
Core Subject : Health,
ournal of Global Pharma Technology is a monthly, open access, Peer review journal of Pharmacy published by JGPT Journal publishes peer-reviewed original research papers, case reports and systematic reviews. The journal allows free access to its contents, which is likely to attract more readers and citations to articles published in JGPT. JGPT publishes original research work that contributes significantly to the scientific knowledge in pharmacy and pharmaceutical sciences- Pharmaceutics, Novel Drug Delivery, Pharmaceutical Technology, Cosmeticology, Biopharmaceutics and Pharmacokinetics, Pharmacognosy, Natural Product Research, Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmaceutical Analysis, Pharmacology, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics, Biotechnology and Applied Computer Technology. For this purpose we would like to ask you to contribute your excellent papers in pharmaceutical sciences.
Arjuna Subject : Kedokteran - Onkologi
Articles 1 Documents
Search results for , issue "Volume 17 Issue 04 (2025) April 2025" : 1 Documents clear
A COMPREHENSIVE REVIEW OF PHARMACEUTICAL VALIDATION AND QUALIFICATION: CONCEPTS, PRACTICES, AND EVOLVING TRENDS Meena, Manish; Jain, Anvesh; Panwar, Mangal S
Journal of Global Pharma Technology Volume 17 Issue 04 (2025) April 2025
Publisher : Journal of Global Pharma Technology

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Abstract

Pharmaceutical validation is a critical component of current Good Manufacturing Practices (cGMP), ensuring that processes, systems, and methods consistently produce products that meet predetermined quality standards. This review explores the principles and types of validation with a focus on process validation, equipment qualification, analytical method validation, cleaning validation, and computer system validation. Emphasis is placed on the regulatory frameworks provided by agencies such as the FDA and EMA, as well as the lifecycle approach to validation, which includes process design, qualification, and continued verification. The article also highlights recent advancements such as risk-based validation strategies, the use of automation and digital tools, and the implementation of ICH guidelines. By integrating both foundational knowledge and emerging trends, this review provides a strategic overview valuable for quality assurance professionals, regulatory personnel, and pharmaceutical researchers. Keywords: Pharmaceutical Validation, Process Qualification, cGMP, Risk-Based Validation, Lifecycle Approach.

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