ISPE-PDA联合指南：药品生产企业质量文化改善.pdf

ISPE – PDA Guide to Improving Quality Culture in Pharmaceutical Manufacturing Facilities ©Copyright 2019 / International Society for Pharmaceutical Engineering (ISPE) / Parenteral Drug Association (PDA). All rights reserved. No part of this document may be reproduced or copied in any form or by any means – graphic, electronic, or mechanical, including photocopying, taping, or information storage and retrieval systems – without written permission of ISPE and PDA. American Society for Quality material reprinted with permission from ASQ Quality Press © 2005 ASQ, . All rights reserved. No further distribution allowed without permission. Limitation of Liability In no event shall ISPE, PDA, or any of their affiliates, or the officers, directors, employees, members, or agents of each of them, be liable for any damages of any kind, including without limitation any special, incidental, indirect, or consequential damages, whether or not advised of the possibility of such damages, and on any theory of liability whatsoever, arising out of in connection with the uses of the information. 2 ©Copyright 2019 / International Society for Pharmaceutical Engineering (ISPE) / Parenteral Drug Association (PDA) Background Quality Culture has always been important within pharmaceutical manufacturing operations. Strong companies know this and have invested resources in systems and personnel to support and promote a focus on quality processes, product quality, and meeting patient needs. More recently, health authorities have placed additional emphasis on quality culture by including it in guidance documents and inspection protocols like the PIC/S Data Integrity Guidance, (1) FDA New Inspection Protocol Project (NIPP), (2) and the MHRA Data Integrity Guideline. (3) Both ISPE and PDA have developed information and resources to help pharmaceutical companies better under- stand why quality culture is importan