Quality Management System for Active pharmaceutical

Quality Management System - integrating GMP into ISOChapter 17: Internal quality auditsPrincipleInternal quality audits, incorporating EN ISO 9001 and GMP requirements, provide a regularand systematic way of obtaining objective evidence about how the QMS is functioning. Theyare an effective means of highlighting activities requiring attention and are, therefore, a meansof driving continuous improvement. This approach should be achieved through the use ofdocumented procedures for planning, implementation and follow-up of internal quality auditsto verify compliance with documented QMS activities, quality manual claims and regulatoryrequirements.17.1 Internal quality audits should be scheduled as part of an ongoing QMS internal auditprogramme covering the scope of the quality system documented in the qualitymanual. The frequency with which different parts are audited should be determinedon the basis of importance to overall QMS performance i.e. activities with knownweaknesses should be audited more frequently.17.2 Internal quality audits should be planned, performed, recorded and followed up bysuitably trained staff who are independent of the area being audited. Internal qualityauditors should be experienced in QMS and GMP in order to perform audits whichbenefit the organisation.17.3 Internal quality system audit findings should be discussed with responsiblemanagement. Agreed, time-limited remedial actions should be recorded and followedup to completion and sign-off.17.4 The follow-up activities should verify the effectiveness of the corrective actiontaken.17.5 Output of the internal quality audit programme should be summarised andperiodically submitted to senior management as an integral part of the managementreview process.17.6 Further guidance for conducting quality system audits is provided in ISO 10011.48