Quality Management System for Active pharmaceutical

Quality Management System - integrating GMP into ISOF. Quality system performance measurementThe API industry is constantly changing. It is driven by the influence of technological advancesand constrained by regulatory requirements, global market forces and local market pricingconsiderations. Setting and achieving medium and long term objectives is, therefore, not easy.When failures occur the true underlying cause(s) must be established if learning points are to beidentified and appropriate corrective measures applied.The EN-ISO 9001 QMS approach requires the adoption of a corporate philosophy ofcontinuous improvement leading to greater efficiency and increased customer satisfaction.Although the implementation of an effective QMS is complex, if done correctly andsuccessfully, it provides a sound basis for progression towards excellence. Experience hasshown that once a QMS has been introduced there is a risk that the pace of ongoingimprovement generated by the introduction of the QMS may falter and lose momentum. It isfor this reason that an objective evaluation of improving performance is essential. A number ofpossibilities exist.At the strategic level, the corporate goal may be to achieve recognition through formal ISOcertification as a stepping stone leading on to gaining the European Quality Award or the USbasedMalcolm Baldridge Award. Each involve detailed evaluation of systems performancewhich, in itself, allows Management to redefine processes which fail to meet performanceobjectives.At the tactical level, an integral part of successfully implementing an effective QMS is the needto identify, agree and use realistic criteria for routinely monitoring performance trends. Somegeneral examples are provided below. The nature and emphasis of performance measures will,inevitably, vary from one company to another:• Improvement initiatives ongoing and/or completed• Quality failures e.g. cost of production failures per month• Percentage on-time delivery to customer• Failure costs per development project as % of project costs• Controlled documents overdue for review• Internal audit observation trends• Customer complaints (numbers, response times)• Laboratory retest rate• Process deviation frequency• Staff training status• Equipment breakdowns per month65