IPEC全文译稿中英文对照.docVIP

PAGE PAGE 1 FOREWORD 前言 The quality of excipients is critical to assure the safety, quality and efficacy of medicines. Excipients have a wide range of applications and are essential components of the drug product formulation. Characteristics that excipients impart to formulated drug products include cosmetic appearance, stability and delivery of the active ingredient. Therefore, applying appropriate Good Manufacturing Practice (GMP) principles to excipients is essential. 辅料的质量对保证药品的安全、质量和功效是至关重要的。辅料的应用范围广泛，是药品生产配方的基本成分。辅料的特性直接影响药品的配方，包括化妆品的外观、稳定性和活性成分的输送。因此，应用适当的GMP规则是辅料的基础。 In contrast to finished dosage forms and Active Pharmaceutical Ingredients (APIs), there are no specific GMP regulations for excipients. In addition, there are a large number of applications of this diverse range of materials which makes the development of excipient GMP guidelines challenging. However, there is a general expectation that excipients are manufactured to recognised GMP principles.与制剂和原料药相比，没有明确的针对辅料的GMP的规则。另外，不同范围的许多应用，让辅料GMP指导原则的发展充满了挑战。然而，总体期望辅料的加工是遵循GMP的规则。 This document proposes GMP appropriate for the manufacture of excipients and is a joint initiative between the International Pharmaceutical Excipients Council (IPEC), as IPEC-Americas and IPEC Europe and the Pharmaceutical Quality Group (PQG), incorporating the IPEC Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients, 2001 with the PQG’s PS 9100:2002 Pharmaceutical Excipients. During guide development, the opportunity was taken to make further clarifications of the text and to ensure alignment with the corresponding clauses in ISO 9001. The top-level headings in Sections 4 to 8 of this document match those in Sections 4 to 8 of ISO 9001 with the exception of Section 4.3 – Change Control. Sub headings have been expanded or reduced from the ISO 9001 structure to provide clarity of text. 该文件建议GMP 适当的用于辅料的生产，并主动结合国际药物辅料协委员会（IPEC），如IPEC美国、IPEC欧洲以及药品质量集团（PQG），结合IPEC针对大宗药物辅料的GMP指南，2001 版PQG’s PS 9100：2002药物辅料。伴