【正文】 and (7) Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review 7 Quality Regulation 21 CFR ? Very similar is the . FDA’s regulation for pharmaceutical manufacturers 21 CFR Part (Quality Control Unit)… responsibilities of a quality control unit...to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, an purity of the drug product ? …and in Part (Production Record Review) Any unexplained discrepancy…or the failure of a batch or any of its ponents to meet any of its specifications shall be thoroughly investigated…The investigation shall extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and followup. 8 Quotes from Current FDA WarningLetters ? Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in pliance with the established quality system requirements and to determine the effectiveness of the quality system . Quality audits shall be conducted by individuals who do not have direct responsibility for the matters and shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented as required by 21 CFR . internal quality audits conducted by your firm failed to verify that the quality system was effective in fulfilling quality system objectives (FDA 483, Item 2). 9 Quotes from Current FDA Warning Letters ? Your firm fails to implement and maintain corrective and preventive action (CAPA) procedures that include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, plaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems as required by 21 CFR 00(a)(1). ? Your firm fails to establish and implement corrective and preventive action (CAPA) procedures that include requirements for identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems as required by 21 CFR (a)(3) ? All activities required by 21 CFR must be verified or validated to ensure that such action is effective and does not adversely affect finished devices, and the results of these activities shall be documented as required by 21 CFR (a)(4) and (b). Your firm39。s CAPA procedures fail to document how analysis is done and fails to require verification/validation that CAPA does not adversely affect finished devices (FDA 483, Item 8). 10 Commission Directive 2023/94/EC Preamble Having regard to the Treaty establishing the European Community, All manufacturers should operate an effective quality management system of their manufacturing operations, which requires the implementation of a pharmaceutical quality assurance system. Article 13 Complaints Any plaint concerning a defect shall be recorded and investigated by the manufacturer… Article 14 Inspections The manufacturer shall conduct repeated selfinspections…in order to monitor the implementation and respect of good manufacturing practice and to propose any necessary corrective measures. Records shall be maintained of such selfinspections and any corrective act