Principles for Quality Management

Quality should be the responsibility of all persons involved in manufacturing.

Each manufacturer should establish, document, and implement an effective system for managing quality that involves the active participation of anagement and appropriate manufacturing personnel.

The system for managing quality should encompass the organizational structure, procedures, processes and resources, as well as activities to ensure confidence that the API will meet its intended specifications for quality and purity. All quality-related activities should be defined and documented.

There should be a quality unit(s) that is independent of production and that fulfills both quality assurance (QA) and quality control (QC) responsibilities. The quality unit can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization.

The persons authorized to release intermediates and APIs should be specified.

•All quality-related activities should be recorded at the time they are performed.

•Any deviation from established procedures should be documented and explained. Critical deviations

•should be investigated, and the investigation and its conclusions should be documented.

•No materials should be released or used before the satisfactory completion of evaluation by the quality

•unit(s) unless there are appropriate systems in place to allow for such use (e.g., release under quarantine

•as described in Section X (10) or the use of raw materials or intermediates pending completion of

•evaluation).

•Procedures should exist for notifying responsible management in a timely manner of regulatory

•inspections, serious GMP deficiencies, product defects and related actions (e.g., quality-related

complaints, recalls, and regulatory actions).