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Procedural Document Control in the Pharmaceutical Industry

1★★ Corresponding author

  1. 1Process and Procedural Document Management, Pfizer, UNITED STATES.

CORRESPONDENCE

Renee Moorefield

Process and Procedural Document Management, Pfizer, UNITED STATES.

renee.moorefield@pfizer.com

Received: 31-07-2024; Revised: 04-09-2024; Accepted: 20-10-2024.

Volume 17, Issue 1 · pp. 79-85 · 2025 · DOI: 10.5530/jyp.20251400

ABSTRACT

Background: Procedural documents such as Standard Operating Procedures (SOPs) are core elements of the pharmaceutical industry for all GxP, or good practice, environments such as GCP (good clinical practice) and GMP (good manufacturing practice). It is vital for colleagues in the Pharmaceutical industry to understand the latest methods in procedural document control and management.Materials and Methods: The author draws on a broad range of experience in multiple global pharmaceutical companies, as well as information from selected literature, to share current best practices. Results/Conclusion:Best practices for writing procedural documents and document management in the pharmaceutical industry are presented. Following these best practices in document creation and control will lead to increased compliance with regulations and will minimize deviations from procedure.

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    Moorefield, R. (2025). Procedural Document Control in the Pharmaceutical Industry. Journal of Young Pharmacists, 17(1), 79-85. https://doi.org/10.5530/jyp.20251400

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    © 2025 Author(s)

    This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms. CC BY-NC-SA 4.0