GMP AND cGMP CONSIDERATIONS课件.ppt

GMP Good Manufacturing Practice Good Management Practice Get More Profit Give more Production GMP Training with out tears 精品文档 GMP All past GMPs are history….It is looking like in rear view mirror and driving 精品文档 Ten Principles of GMP Design and construct the facilities and equipments properly Follow written procedures and Instructions Document work Validate work Monitor facilities and equipment Write step by step operating procedures and work on instructions Design ,develop and demonstrate job competence Protect against contamination Control components and product related processes Conduct planned and periodic audits 精品文档 Beyond GMP Reduce pollution -? Zero discharge Adaptation of environment friendly methods Consideration for better and healthier life tomorrow Consideration of ethics in life One should begin with end in mind otherwise it will be the beginning of the end 精品文档 Cost of effective GMP In fact Cost benefits – positive cost benefits of GMP/QA Good plant lay out, Smooth work flows, Efficient documentation systems, well controlled process, good stores lay outs and stores records- These are Good manufacturing practices Reduction in work in process and inventory holding costs Avoidance of cost of Quality failure ( cost of waste, of rework, of recall, of consumer compensation and of loss of company reputation) 精品文档 List of important documents in GMP Policies SOP Specifications MFR (Master Formula Record) BMR Manuals Master plans/ files Validation protocols Forms and Formats Records 精品文档 10 attributes of a good document Accurate Clear Complete Consistent Indelible Legible Timely Direct Authentic Authorized 精品文档 Certifying agencies ICH. WHO. US FDA. EU/EMEA. www.emea.europa.eu 精品文档 How do GMPs of different countries compare? At a high level, GMPs of various nations are very similar; most require things like: Equipment and facilities being properly designed, maintained, and cleaned Standard Operating Procedures (SOPs) be writ