Quality Management System for Active pharmaceutical

Quality Management System - integrating GMP into ISO• To be effective the QMS should have the visible and ongoing support of topmanagement.• To fully benefit the company the QMS should involve all staff whose activities influencequality, have a clear and unambiguous continuous improvement focus, and incorporaterelevant, realistic performance measures with emphasis on reducing failure costs, andsatisfying (internal and external) customer needs.• The quality manual occupies the highest level in the document hierarchy. It overviewsand acts as a directory to the QMS, capturing the unique character of the company.• An effective QMS has a minimum of paperwork, and should constantly question the needfor the existing documents. In contrast, a bureaucratic and inefficient QMS will arise ifthe Standard is misinterpreted, and incorrectly applied.For the purpose of this guidance document, the original EN-ISO 9001 subclauses have beenaddressed in twenty distinct chapters supplemented by four annexes in recognition of theimportance of issues concerning hygiene; facilities and utilities; validation; and change control,to the API industry. Each chapter and each of the four annexes are structured in a way whichsummarises the appropriate QMS principle and philosophy as a preface to the main text whichintegrates relevant GMP requirements and QMS principles. The rationale/justification andbusiness benefits of a combined QMS/GMP approach are considered in chapter 6. Chapter 7addresses the importance of lower level and higher level performance measures for continuedsuccess, and as a solid foundation for those wishing to progress to European QualityAward/World Class status.Safety, health and environment are not specifically addressed. However, it is widelyacknowledged that implementation of a robust QMS provides a sound basis for the futuredevelopment of such an Integrated Management System.In this Guide the term “should” indicates requirements that are expected to apply unless shownto be inapplicable or replaced by an alternative demonstrated to provide at least an equivalentlevel of quality assurance.4