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ISSN: 2582-8266 (Online)  || UGC Compliant Journal || Google Indexed || Impact Factor: 9.48 || Crossref DOI

Fast Publication within 2 days || Low Article Processing charges || Peer reviewed and Referred Journal

Research and review articles are invited for publication in Volume 21, Issue 2 (November 2026).... Submit articles

DEVELOPING STRATEGIES TO IMPROVE PRODUCTION DOCUMENTATION QUALITY IN THE PHARMACEUTICAL INDUSTRY: A CASE STUDY OF PT. XYZ

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  • DEVELOPING STRATEGIES TO IMPROVE PRODUCTION DOCUMENTATION QUALITY IN THE PHARMACEUTICAL INDUSTRY: A CASE STUDY OF PT. XYZ

Farah Azzahro, Faradhina Azzahra *, Chaterina Alvina Prima Hapsari and Diana Puspita Sari

Industrial Engineering Department, Faculty of Engineering, Universitas Diponegoro, Jl. Prof. Soedarto, SH, Universitas Diponegoro, Semarang, Central Java, Indonesia.
* Corresponding Author
ORCID Details
Faradhina Azzahra: https://orcid.org/0000-0002-7311-9091
Chaterina Alvina Prima Hapsari: https://orcid.org/0000-0001-6363-5044
Diana Puspita Sari: https://orcid.org/0000-0003-1989-8925  

Research Article

 

World Journal of Advanced Engineering Technology and Sciences, 2026, 21(01), 096–102

Article DOI: 10.30574/wjaets.2026.21.1.0469

DOI url: https://doi.org/10.30574/wjaets.2026.21.1.0469

Received on 01 September 2026; revised on 08 October 2026; accepted on 10 October 2026

In the pharmaceutical industry, documentation quality in toll manufacturing products is a key factor in maintaining customer satisfaction and trust. The decline in customer satisfaction in toll manufacturing services of PT XYZ is reflected in the decrease of the Customer Satisfaction Index (CSI) from 2024 to 2025, as well as the high gap in the attributes of accuracy and completeness of batch record documentation, where customer expectations reached 100 while the performance was only 72. This study aims to identify the root causes of the high gap in the attributes of accuracy and completeness in filling out batch records, analyze internal and external factors that influence it, formulate alternative improvement strategies through SWOT analysis, and determine strategy priorities based on Quantitative Strategic Planning Matrix (QSPM) analysis. The results indicate that the main problems stem from human resources, methods, and systems, including high workload, differences in understanding, and a still paper-based documentation system. The QSPM results were used to determine priority strategies, including optimizing training programs based on audit findings, implementing an integrated documentation system, and standardizing training programs. These strategies are expected to improve the accuracy and completeness of batch records and enhance customer satisfaction.

Customer Satisfaction Index (CSI), Batch record, Toll Manufacturing, Fishbone Diagram, SWOT, QSPM

https://wjaets.com/sites/default/files/fulltext_pdf/WJAETS-2026-0469.pdf

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Farah Azzahro, Faradhina Azzahra, Chaterina Alvina Prima Hapsari and vDiana Puspita Sari. DEVELOPING STRATEGIES TO IMPROVE PRODUCTION DOCUMENTATION QUALITY IN THE PHARMACEUTICAL INDUSTRY: A CASE STUDY OF PT. XYZ. World Journal of Advanced Engineering Technology and Sciences, 2026, 21(01), 096–102; Article DOI: https://doi.org/10.30574/wjaets.2026.21.1.0469

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