Procedural Document Control in the Pharmaceutical Industry
Renee Moorefield1★★ Corresponding author
- 1Process and Procedural Document Management, Pfizer, UNITED STATES.
CORRESPONDENCE
Renee Moorefield
Process and Procedural Document Management, Pfizer, UNITED STATES.
Received: 31-07-2024; Revised: 04-09-2024; Accepted: 20-10-2024.
Volume 17, Issue 1 · pp. 79–85 · PUBLISHED · 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. (). Procedural Document Control in the Pharmaceutical Industry. Journal of Young Pharmacists, 17(1), 79–85. https://doi.org/10.5530/jyp.20251400