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ZENODO
Article . 2025
License: CC BY
Data sources: ZENODO
ZENODO
Article . 2025
License: CC BY
Data sources: Datacite
ZENODO
Article . 2025
License: CC BY
Data sources: Datacite
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A Review on Documentation and Record Management in the Pharmaceutical Industry

Authors: K. D. Jepulkar*, K. G. Mekalwar, H.S. Firdoas, J.S. Watsar, V.G. Pete;

A Review on Documentation and Record Management in the Pharmaceutical Industry

Abstract

Documentation within the pharmaceutical industry plays a vital role in ensuring quality assurance, regulatory adherence, and smooth manufacturing operations. It includes various essential records such as Standard Operating Procedures (SOPs), Master Formula Records (MFR), Batch Manufacturing Records (BMR), In-Process Quality Control (IPQC) reports, and Drug Master File (DMF) data. These documents establish a systematic framework for organizing, executing, and tracking manufacturing processes, ensuring product consistency and complete batch traceability. Effective documentation not only aids in regulatory audits and inspections but also supports process validation, minimizes human error, and upholds data integrity. Moreover, it acts as a communication bridge between departments, providing clear process guidelines and enabling prompt management of deviations. This review underscores the significance of accurate and comprehensive documentation in maintaining Good Manufacturing Practice (GMP) compliance, enhancing operational performance, and protecting patient health. It further addresses common issues such as documentation mistakes, incomplete data, and record management challenges, while suggesting solutions like digital transformation and automated documentation systems. In summary, strong documentation practices are essential for producing safe, effective, and high-quality pharmaceutical products.

Keywords

Master Formula Record, Batch Manufacturing Record, SOP, In-Process Quality Control, Stability Studies and Drug Master File

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average
Green