Follow
=>> Quality should be the responsibility of all involved in production.
=>> Each manufacturer should establish, document and implement an effective system for quality management that involves the active participation of management and appropriate manufacturing personnel.
=>> The system for quality management must include the organizational structure, procedures, processes and resources, as well as the activities necessary 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 manufacturing and that fulfills both quality assurance (QA) and quality control (QC) responsibilities. This may be in the form of separate QA and QC units or single individuals or groups, depending on the size and structure of the organization.
=>> Intermediates and authorized persons to expose the API should be specified.
=>> All quality related activities should be recorded when 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 material should be released or used prior to satisfactory completion of evaluation by the quality unit(s) unless appropriate measures are in place to permit such use (such as release under quarantine as described in Section 10.20 or use of raw materials or intermediates pending completion of evaluation).
=>> Procedures should exist to notify responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects, and related actions (eg, quality complaints, recalls, regulatory actions, etc.).
=>> To reliably achieve quality objectives there must be a comprehensively designed and properly implemented quality system that includes good manufacturing practices, quality control and quality risk management.
