Procedural Document Control in the Pharmaceutical Industry

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.

Keywords: Compliance; Standard Operating Procedure; Document Control; Document Management; Process