《欧盟gmp风险管理英文》由会员分享，可在线阅读，更多相关《欧盟gmp风险管理英文（25页珍藏版）》请在金锄头文库上搜索。
1、1 EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, 14 February 2008 EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Anne
2、x 20 Quality Risk Management Document History Adoption as ICH Q9 guideline Step 4 November 2005 Deadline for coming into operation 01 March 2008 Commission Europenne, B-1049 Bruxelles / Europese Commissie, B-1049 Brussel Belgium. Telephone: (32-2) 299 11 11 2 Table of Contents Foreword it provides a
3、n inventory of internationally acknowledged risk management methods and tools together with a list of potential applications at the discretion of manufacturers. It is understood that the ICH Q9 guideline was primarily developed for quality risk management of medicinal products for human use. With th
4、e implementation in Annex 20 benefits of the guideline, such as processes, methods and tools for quality risk management are also made available to the veterinary sector. While the GMP guide is primarily addressed to manufacturers, the ICH Q9 guideline, has relevance for other quality guidelines and
5、 includes specific sections for regulatory agencies. However, for reasons of coherence and completeness, the ICH Q9 guideline has been transferred completely into GMP Annex 20. Further consideration of regulatory aspects, such as with the revision of the “Compilation of Community Procedures on Inspe
6、ctions and Exchange of Information“ and in some quality guidelines, as published by the EMEA, will follow in a step-by-step approach. 4 1 Introduction Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, publi
7、c health, pharmacovigilance, and by agencies regulating these industries. Although there are some examples of the use of quality risk management in the pharmaceutical industry today, they are limited and do not represent the full contributions that risk management has to offer. In addition, the impo
8、rtance of quality systems has been recognized in the pharmaceutical industry and it is becoming evident that quality risk management is a valuable component of an effective quality system. It is commonly understood that risk is defined as the combination of the probability of occurrence of harm and
9、the severity of that harm. However, achieving a shared understanding of the application of risk management among diverse stakeholders is difficult because each stakeholder might perceive different potential harms, place a different probability on each harm occurring and attribute different severitie
10、s to each harm. In relation to pharmaceuticals, although there are a variety of stakeholders, including patients and medical practitioners as well as government and industry, the protection of the patient by managing the risk to quality should be considered of prime importance. The manufacturing and
11、 use of a drug (medicinal) product, including its components, necessarily entail some degree of risk. The risk to its quality is just one component of the overall risk. It is important to understand that product quality should be maintained throughout the product lifecycle such that the attributes t
12、hat are important to the quality of the drug (medicinal) product remain consistent with those used in the clinical studies. An effective quality risk management approach can further ensure the high quality of the drug (medicinal) product to the patient by providing a proactive means to identify and
13、control potential quality issues during development and manufacturing. Additionally, use of quality risk management can improve the decision making if a quality problem arises. Effective quality risk management can facilitate better and more informed decisions, can provide regulators with greater as
14、surance of a companys ability to deal with potential risks and can beneficially affect the extent and level of direct regulatory oversight. The purpose of this document is to offer a systematic approach to quality risk management. It serves as a foundation or resource document that is independent of
15、, yet supports, other ICH Quality documents and complements existing quality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment. It specifically provides guidance on the principles and some of the tools of quality risk management that can
16、 enable more effective and consistent risk based decisions, both by regulators and industry, regarding the quality of drug substances and drug (medicinal) products across the product lifecycle. It is not intended to create any new expectations beyond the current regulatory requirements. It is neither always appropriate nor always necessary to use a formal risk management process (using recognized tools and/ or internal procedures
