Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP

There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance emphasis. The 2011 Pharma Process Validation Guidance Document emphasizes “P&PC” to ensure “homogeneity within batch” and “consistency between batches”, basic Dr. Deming, et al. Such changes in regulatory focus should have a major impact on individual compliance objectives, efforts and measurements of success. Using P&PC, lean, six sigma / SPC, together with process mapping / flow charting and HACCP, will yield major business benefits as well: Reduced waste / scrap, early warning of process shifts before non-conforming product is manufactured, increase efficiencies, minimal need for re-validations of equipment and/or process, and opportunities for improvement in quality, through-put. A case of regulatory / business “win-win”.

P&PC systems, metrics, and information / analysis, combined lean principles, and six sigma / SPC tools, and the FDA’s QSIT for medical devices and pharmaceutical requirements, together provide an effective, proactive and aggressive / robust methodology to maintain a production process in a “state of statistical control”, and in CGMP compliance for any regulated industry. Software, data integrity, and cybersecurity issues are considered. Such a system greatly reduces the need for equipment / process re-verification / -qualification / -validation.