Gmp/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers: v. 3

This new edition continues a two-decade tradition of widely-used guidance for performing effective audits. Comprehensive in its coverage, this practical guide should prove a valuable tool that offers effective training for new auditors and updates current auditors on new standards and regulations. It helps defuse FDA inspectors frustration in not being able to view audit reports. When combined with a procedure, the checklists demonstrate that comprehensive auditing is part of the quality system.