Device Good Manufacturing Practices: A Workshop Manual

摘要

This manual was developed by OSMA and other offices in the Bureau of Medical Devices (BMD) to aid small manufacturers in completing, maintaining, or expanding their own quality assurance programs. Contents include educational materials, aids, and examples of how to implement elements of a quality assurance program, together with detailed samples of procedures, control forms, and associated data. Although the examples offered in this manual do not constitute statements of policy binding on FDA, they are typical models from successful quality assurance programs found in the device industry. Subjects covered include quality assurance programs, production planning, buildings and equipment, master record, components and materials, production control, labeling and packaging, device evaluation, complaints and investigations, audits, factory inspections, and exemptions and variances.