Improving Efficiency In Quality Assurance Documentation Cell With Lean Thinking
The pharmaceutical industry is regulated by regulatory agencies like the U.S. Food and Drug Administration (FDA), the European Union (EMEA), WHO and the Ministries of Health of various countries and guidelines such as the Good Practice (GxP) guidelines. The GxP guidelines are primarily Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP), ensuring the quality of the processes leading to the final product. The pharmaceutical industry has to comply with regulations from the law and health authorities. This article provides an insight into how lean thinking concepts like 5S can help the Quality Assurance Documentation cell of a Pharmaceutical company and can increase its efficiency of document upkeep, storage, archival, distribution, presentation and retrieval.