《《(英文版)药用包装材料质量标准ISO15378-2016.doc》.doc

Introduction 0.1 General This international standard identifies Good Manufacturing Practice (GMP) principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products. The realization of GMP principles in production and control of primary packaging materials within organizations is of great importance for the safety of a patient using the medicinal product, because of their direct product contact. The application of GMP for pharmaceutical packaging materials should ensure that these materials meet the needs and requirements of the pharmaceutical industry.This international Standard is an application standard for primary packaging materials which contains the requirements text of ISO 9001:2000.The conventions for the layout of this International Standard are the following.— Those clauses or subclasses that are quoted directly and unchanged from ISO 9001:2000are in coxed text.— Texts in italics contain additionally relevant GMP requirements for primary packaging materials.— GMP terms and definitions are included in Clause 3. If listed, the source is referred to in brackets. ISO 9001:2000, Quality management systems — Requirements 0.1 General The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organizations quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement. This International Standard can be used by internal and exte