NSF 363-2014 Good Manufacturing Practices (GMP) for Pharmaceutical Excipients.pdf

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1、NSF International Standard / American National StandardNSF/ANSI 363 - 2014Good Manufacturing Practices(GMP) for PharmaceuticalExcipientsNSF International, an independent, not-for-profit, non-governmental organization, is dedicated to being the leading global provider of public health and safety-base

2、d risk management solutions while serving the interests of all stakeholders. This Standard is subject to revision. Contact NSF to confirm this revision is current. Users of this Standard may request clarifications and interpretations, or propose revisions by contacting: Chair, Joint Committee on Pha

3、rmaceutical Excipients c/o NSF International 789 North Dixboro Road, P. O. Box 130140 Ann Arbor, Michigan 48113-0140 USA Phone: (734) 769-8010 Telex: 753215 NSF INTL FAX: (734) 769-0109 E-mail: infonsf.org Web: http:/www.nsf.org NSF/IPEC/ANSI 3632014 i NSF International Standard/ International Pharm

4、aceutical Excipients Council/ American National Standard for Pharmaceutical Excipients Good Manufacturing Practices (GMP) for Pharmaceutical Excipients Standard Developer NSF International NSF International Designated as an ANSI Standard November 17, 2014 American National Standards Institute ii Pre

5、pared by The NSF Joint Committee on Pharmaceutical Recipients Adopted December 2014 Published by NSF International PO Box 130140, Ann Arbor, Michigan 48113-0140, USA For ordering copies or for making inquiries with regard to this Standard, please reference the designation “NSF/IPEC/ANSI 363 2014.” C

6、opyright 2014 NSF International Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from NSF International. Printed in the United States of Ame

7、rica. iii Disclaimers1NSF, in performing its functions in accordance with its objectives, does not assume or undertake to discharge any responsibility of the manufacturer or any other party. The opinions and findings of NSF represent its professional judgment. NSF shall not be responsible to anyone

8、for the use of or reliance upon this Standard by anyone. NSF shall not incur any obligation or liability for damages, including consequential damages, arising out of or in connection with the use, interpretation of, or reliance upon this Standard. NSF Standards provide basic criteria to promote sani

9、tation and protection of the public health. Provisions for mechanical and electrical safety have not been included in this Standard because governmental agencies or other national standards-setting organizations provide safety requirements. Participation in NSF Standards development activities by re

10、gulatory agency representatives (federal, local, state) shall not constitute their agencys endorsement of NSF or any of its Standards. Preference is given to the use of performance criteria measurable by examination or testing in NSF Standards development when such performance criteria may reasonabl

11、y be used in lieu of design, materials, or construction criteria. The illustrations, if provided, are intended to assist in understanding their adjacent standard requirements. However, the illustrations may not include all requirements for a specific product or unit, nor do they show the only method

12、 of fabricating such arrangements. Such partial drawings shall not be used to justify improper or incomplete design and construction. Unless otherwise referenced, the annexes are not considered an integral part of NSF Standards. The annexes are provided as general guidelines to the manufacturer, reg

13、ulatory agency, user, or certifying organization. 1The information contained in this Disclaimer is not part of this American National Standard (ANS) and has not been processed in accordance with ANSIs requirements for an ANS. Therefore, this Disclaimer may contain material that has not been subjecte

14、d to public review or a consensus process. In addition, it does not contain requirements necessary for conformance to the Standard. iv This page is intentionally left blank.v Contents 1 General . 1 1.1 Introduction . 1 1.2 Scope . 1 1.3 Purpose 2 2 Reference documents . 2 2.1 Normative references 2

15、2.2 Informational references 2 3 Definitions . 3 4 Quality management system . 7 4.1 General requirements . 7 4.2 Documentation requirements 9 4.3 Change control . 10 5 Management responsibility 11 5.1 Management commitment . 11 5.2 Customer focus . 11 5.3 Quality policy 11 5.4 Planning 12 5.5 Respo

16、nsibility, authority, and communication 12 5.6 Management review 13 6 Resource management . 14 6.1 Provision of resources . 14 6.2 Human resources 14 6.3 Infrastructure . 15 6.4 Work environment . 17 7 Excipient realization 18 7.1 Planning of excipient realization 18 7.2 Customer-related processes .

17、 19 7.3 Design and development (out of scope) 19 7.4 Purchasing 19 7.5 Production and service provision . 20 7.6 Control of monitoring and measuring equipment 23 8 Measurement, analysis and improvement 23 8.1 General . 23 8.2 Monitoring and measurement 23 8.3 Control of nonconforming product 27 8.4

18、Analysis of data. 29 8.5 Improvement . 29 vi This page is intentionally left blank.vii Foreword2The purpose of NSF/IPEC/ANSI 363 is to serve as an evaluation tool for analyzing pharmaceutical excipients. Certification to this Standard serves as a communication tool between manufacturers of excipient

19、s and finished product, pharmaceutical regulators, pharmacy organizations, and consumers. This Standard provides guidance to allow for the determination that a pharmaceutical excipient is within the specifications stated by the manufacturer, either qualitatively or quantitatively, and that it does n

20、ot contain specific undeclared contaminants. In some instances, validated laboratory methods are not yet available for analyzing certain ingredients. In such cases, new methods will be added to this Standard as they become available. NSF/IPEC/ANSI 363 was developed with participation from the pharma

21、ceutical excipients manufacturers, public health regulators, and distributors of pharmaceutical excipients. Suggestions for improvement of this Standard are welcome. This Standard is maintained on a Continuous Maintenance schedule and can be opened for comment at any time. Comments should be sent to

22、 Chair, Joint Committee on Pharmaceutical Excipients at standardsnsf.org, or c/o NSF International, Standards Department, P.O. Box 130140, Ann Arbor, Michigan 48113-0140, USA. 2The information contained in this Foreword is not part of this American National Standard (ANS) and has not been processed

23、in accordance with ANSIs requirements for an ANS. Therefore, this Foreword may contain material that has not been subjected to public review or a consensus process. In addition, it does not contain requirements necessary for conformance to the Standard. viii This page is intentionally left blank.1 2

24、014 NSF NSF/IPEC/ANSI 363 2014 NSF/IPEC/ANSI Standard for Pharmaceutical Excipients Good Manufacturing Practices (GMP) for Pharmaceutical Excipients 1 General 1.1 Introduction The principles outlined in this Standard provide a comprehensive basis for the quality management system used in the manufac

25、ture of pharmaceutical excipients. Implementation of these principles shall result in the achievement of three main objectives: a) achieve excipient realization the organization shall implement and maintain a system that delivers excipients with the quality attributes necessary to meet the requireme

26、nts and expectations of customers, pharmaceutical users, and regulatory authorities; b) establish and maintain a state of control the organization shall ensure the manufacture and supply of excipients is in accordance with this Standard, thus providing customers with some assurance of continued suit

27、ability and reliability of supply; and c) facilitate continual improvement the organization shall collect objective evidence to continually develop and enhance the application of these quality management system principles to further assure excipient consistency. 1.2 Scope This Standard is intended t

28、o define Good Manufacturing Practices (GMP) for excipient manufacture and distribution3for use in drug products. It sets minimum requirements for GMP applicable to all commercially available excipients. This Standard includes the minimum requirements of a quality management system for excipient manu

29、facture drawing on principles of GMP and quality systems from other relevant standards such as those referenced in section 2.2. NOTE 1 The requirements of this Standard may not be sufficient for all applications of excipients. It is the users responsibility to determine whether or not this Standard

30、meets the requirements for their intended use. NOTE 2 Auditing excipient manufacturers ensures conformance to this Standard. This Standard is also intended to be used by duly accredited or otherwise suitably qualified 3rdparties. NOTE 3 Each user of a 3rdparty auditing service should make its own de

31、termination as to the qualifications of the 3rdparty and the applicability of the report and/or certificate issued in satisfying its requirements, including those pertaining to its intended use of the excipient. 3GMP applies to distribution per the Federal Food, Drug, and Cosmetic Act (FD 3.58 retes

32、t/re-evaluation internal; 3.59 retest interval). 3.65 significant change: Any change that has the potential to alter an excipients physical, chemical, or microbiological property from the norm, and/or that may alter the excipients performance in the dosage form. 3.66 solvent: An inorganic or organic

33、 liquid used as a vehicle for the presentation of solutions or suspensions in the manufacture of an excipient. 3.67 specification: A test or list of tests, references to analytical procedures and appropriate acceptance criteria that are numerical limits, ranges or other criteria that a material is r

34、equired to meet. 3.68 specificity: The ability to assess unequivocally the analyte in the presence of components that may be expected to be present. Typically these might include impurities, degradants, matrix, etc. 3.69 stability: The continued conformance of the excipient to its specifications. 3.

35、70 state of control: A condition in which the set of controls consistently provides assurance of continued process performance and product quality. 3.71 subcontractor: A third party for outsourced work or services that contribute in whole or in part to the manufacture of excipients. 3.72 top managem

36、ent: A person or group of people who direct and control an organization at the highest level. The highest level may either be at the site or corporate level and will depend on how the quality management system is organized. 3.73 traceability: The ability to determine the history, application, or loc

37、ation that is under consideration (for example, origin of materials and parts, processing history, or distribution of the product after delivery). 3.74 validation: A documented program that provides a high degree of assurance that a specific product, method, procedure (e.g., cleaning), or system wil

38、l consistently produce a result meeting predetermined acceptance criteria. 3.75 verification: The application of methods, procedures, tests, and other evaluations, in addition to monitoring, to determine compliance with GMP principles. 4 Quality management system 4.1 General requirements The organiz

39、ation shall document, manage, and implement the quality management systems and GMP required to assure excipient quality. 2014 NSF NSF/IPEC/ANSI 363 2014 8 NOTE The elements of the quality management should be applied in a manner that is appropriate and proportionate to each of the product lifecycle

40、stages, recognizing the different goals and knowledge available at each stage. The organization shall maintain and continually improve the quality management system and GMP in accordance with the requirements of this Standard. 4.1.1 General quality management systems organization In defining the qua

41、lity management processes the organization shall: a) define individual and collective roles, responsibilities, authorities and inter-relationships of all organizational units related to the excipient quality management system; ensure these interactions are communicated and understood at all relevant

42、 levels of the organization (see 5.5.1); b) define the interactions of the processes stated herein, with the operations needed for the quality management system and the implementation of GMP; NOTE An independent quality unit with authority to fulfill certain excipient quality system responsibilities

43、 may be required by regional regulations. c) determine the criteria and methods to ensure that the operation and control of these processes and GMP are effective; d) ensure that there are suitable resources, including availability of information, to support the operation and measurement of these pro

44、cesses; e) monitor, and, where applicable, measure and analyze these processes and procedures to gain knowledge and understanding of them; and NOTE Processes here include the quality management system and the manufacturing and delivery operations. f) apply actions based on the science and knowledge

45、gained to improve these processes and the quality management system while maintaining consistent excipient quality. NOTE Quality risk management may be useful for identifying and prioritizing areas for continual improvement.124.1.2 Outsourcing general requirements Where manufacturing, testing, or ot

46、her operations that may affect excipient quality are outsourced, the organization shall: a) define the responsibility for quality and the control measures within the quality management system (see 7.4); and b) demonstrate that the applicable GMP principles in accordance with this Standard are applie

47、d to those operations. 12ICH Harmonised Tripartite Guideline, Q9: Quality Risk Management, November 20055 2014 NSF NSF/IPEC/ANSI 363 2014 9 4.2 Documentation requirements 4.2.1 General The design, organization, and documentation of the quality system shall be structured to facilitate common understa

48、nding and consistent application. The use of appropriate quality risk management principles shall be incorporated into changes to the quality management system. NOTE Quality risk management may be a useful aid to identifying activities, operations, and processes that pose a risk to consistent physic

49、al, chemical, and/or microbiological excipient quality. The following documents shall be included in the quality management system: a) Quality Manual, (see 4.2.2); b) Quality Objectives; c) documents and records required by this Standard and any other documents necessary for the effective planning, operation and control of the processes; and d) a documented risk assessment that defines and justifies when the as/if/where applicable clauses in this Standard are not implemented. NOTE 1 A single document may address the requirements of one or more