GMP/ISO Quality Audit Manual for Healthcare Manufacturers
Subtitle: Regulations, Standards, and Guidelines
Edition: 6th ed.
Publisher: Informa Healthcare
Published: 2004
Place of publication: Hoboken
Language: eng
Format: [electronic resource] :
Number of pages: 453
ISBN-13: 9780203026656
Subjects: Medical instruments and apparatus industry; Quality control
Description: 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.
Notes: Description based on print version record.
Table of contents: title: 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.; title: 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; title: Part 3; Quality Systems; title: Models for Quality Assurance in Design, Development, Production, Installation and Servicing; Quality Management Systems; title: Requirements; Qualit.