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The new Good automated manufacturing practices (GAMP)-5 guidelines were released February 2008 at the ISPE(International Society for Pharmaceutical Engineering) Manufacturing Excellence Conference in Tampa, Florida. These guidelines are the latest, up-to-date thinking in the approach to validation of GxP computerized systems. The purpose of the guidelines is to “provide a cost effective framework of good practice to ensure that computerized systems are fit for use and compliant with regulation.” There are five key concepts to GAMP 5: • Product and Process Understanding. • Lifecycle approach within QMS. • Scalable Lifecycle Activities. • Science Based Quality Risk Management. • Leveraging Supplier Involvement. Understanding the product and process is critical in determining system requirements and for making science and risk-based decisions to ensure that the system is “fit for use.” In determining “fit for use,” attention should be focused on “those aspects that are critical to patient safety, product quality, and data integrity.” Defining a lifecycle approach to a computerized system has been expanded from GAMP 4 to include all phases and activities from concept and implementation through operation and retirement. Some applications of GAMP- 5 in Pharmaceutical industries like Monitoring manufacturing, production and storage environments in the pharmaceutical industry, Monitoring the autoclaving process in the pharmaceutical industry, Water purification in the pharmaceutical industry, Freeze drying in the pharmaceutical industry
Computerized systems, Guidelines, Risk- based approach, Validation, Patient safety, Product quality.