Quality Management System for Active pharmaceutical

Quality Management System - integrating GMP into ISOD. Quality SystemChapter 1: Management responsibilityPrincipleThe API manufacturer should define a quality policy which has to be implemented throughoutthe whole organisation. The quality policy should be documented, together with responsibilitiesand lines of authority, for all levels of the organisation. It should aim to prevent occurrence ofnonconformities, but when they do occur, it should allow for implementation of correctivemeasures. The API manufacturer should provide the necessary resources and trained personnelto meet quality needs. A representative of management should be appointed to oversee theestablishment of a quality system and to assess its ongoing performance.1.1 Quality policy1.1.1 The API manufacturer should document a quality policy which gives direction to theachievement of corporate quality objectives through a commitment to GMP, and toISO QMS principles.1.1.2 The quality policy should emphasise the importance of planning to avoid qualityfailures. The need for continuous improvement should be emphasised by use ofspecific performance measures (see Part G).1.1.3 Management should ensure that the quality policy is fully understood andimplemented by all members of staff.1.1.4 Management should clearly demonstrate their continuing support for the qualitypolicy (e.g. by regular quality briefings).1.2 Organisation1.2.1 The organisation should be documented.1.2.2 Responsibilities should be reflected in organisation charts and job descriptions.Lateral and horizontal quality critical interfaces should also be identified. TheQuality Function should be independent of production.1.2.3 All staff whose activities influence quality should be appropriately qualified, througheducation, training, experience or any combination thereof to perform their assignedresponsibilities.12