Quality Management System for Active pharmaceutical

Quality Management System - integrating GMP into ISOAnnex D: Change controlPrincipleA continuous improvement-focused QMS is, by definition, a dynamic entity. The introductionto this publication stresses the need to adequately document quality critical systems to ensureuniformity and understanding. Changes are, therefore, intimately linked with documentationand its control. Quality critical changes should be comprehensively planned, carefullycontrolled, and fully documented. All relevant stakeholders, including regulatory authoritiesand customers where appropriate, should be involved and/or notified, depending upon thenature and significance of the proposed change.D.1 Change control proceduresD.1.1Evaluation and approval of proposed changes to specifications, test procedures,production processes, production equipment, etc., should be controlled by writtenprocedures.D.1.2Evaluation of a proposed change should include consideration of the following:- significance of the proposed change- effect on quality of final API- impact on dosage form subsequently manufactured from API (e.g. throughchanges to impurity profile, crystal form, particle size, residual solvents, stabilityetc.)- need for operator training- need to involve regulatory authorities- need to inform customers- need to revalidate processes.D.1.3Proposed changes should be reviewed and approved by the relevant departments andthe Quality Function.D.2 Implementation of changesD.2.1D.2.2D.2.3All documents affected by the change should be identified and revised accordingly.Any operator training needed should be satisfactorily completed (and recorded).Several batches of API produced following implementation of the change should beextensively evaluated.62