دانلود کتاب GMP/ISO Quality Audit Manual for Healthcare Manufacturers : Regulations, Standards, and Guidelines

Volume 2 of this set contains the full text of the FDA regulations, EC and IPEC guidelines, and ISO/BSI standards referenced in the checklists furnished in Volume I. Content: Book Cover; Title; Copyright; Contents; Part II Electronic Records/Electronic Signatures; Part 803 Medical Device Reporting; Part 806 Medical Devices; Reports of Corrections and Removals; Part 821 Medical Device Tracking Requirements; Part 820 Quality System Regulation; Part 211 Current Good Manufacturing Practice for Finished Pharamaceuticals; Guidance for Industry* Q7A Giid Manufacturing Practice Guidance for Active Pharmaceutical Ingredients; Part 1301 Registration of Manufacturers, Distributors and Dispensers of Controlled Substances; Military Specification. Standard Practice for Established Reliability and High Reliability Qualified Products List (QPL) Systems For Electrical, Electronic, and Other Optic Parts SpecificationsThe Rules Governing Medicinal Products in the European Union; Quality Managemnet and Quality Assurance Standards--Part 3; Quality Systems--Models for Quality Assurance in Design, Development, Production, Installation and Servicing; Quality Management Systems--Requirements; Qualit. Abstract: Volume 2 of this set contains the full text of the FDA regulations, EC and IPEC guidelines, and ISO/BSI standards referenced in the checklists furnished in Volume I