who验证指南Word格式文档下载.docx

1、All rights reserved.This draft is intended for a restricted audience only, i.e. the individuals and organizations having received this draft. The draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated oradapted, in part or in whole, in any form or by any mean

2、s outside these individuals and organizations （including the organizations concerned staff and member organizations） without the permission of WHO. The draft should not be displayed on any website.Please send any request for permission to:Dr Sabine Kopp, Quality Assurance & Safety: Medicines （QSM）,

3、Department of Essential Drugs and Medicines Policy （EDM）, World Health Organization, CH-1211 Geneva 27, Switzerland.Fax: （41-22） 791 4730; e-mails:The designations employed and the presentation of the material in this draft do not imply the expression of any opinion whatsoever on the part of the Wor

4、ld Health Organization concerning the legal status of any country,territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.The mention of specifi

5、c companies or of certain manufacturers products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial cap

6、ital letters.The World Health Organization does not warrant that the information contained in this draft is complete and correct and shall not be liable for any damages incurred as a result of its use.Working document QS/03.055/Rev.1page 2TENTATIVE SCHEDULE FOR THE ADOPTION PROCESS OF DOCUMENT QAS/0

7、3.055: SUPPLEMENTARY GUIDELINES ON GMP: VALIDATIONWorking document QS/03.055/Rev.1 page 3SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES（GMP）:CONTENTS1. Introduction2. Glossary3. Scope of document4. Validation4.1 Approaches to validation4.2 Scope of validation4.3 Benefits of validation5. Qu

8、alification6. Calibration and verification7. Validation team8. Validation Master Plan （VMP）8.1 General requirements8.2 Specific requirements9. Validation Protocol （VP）10. Validation Report （VR）11. Relationship between validation and qualification11.1 Premises11.2 Systems11.2.1 Heating, Ventilation a

9、nd Air ConditioningSystem （HVAC）11.2.2 Water system11.3 Equipment11.4 Processes11.5 Procedures11.5.1 Analytical method11.5.2 Packaging component11.5.3 Cleaning validation11.6 Computer systems validation12. Qualification stages Page 5 6 8 8 8 8 10 10 10 11 12 12 12 13 14 14 14 15 16 16 17 17 17 17 18

10、 18 18 19page 412.1 Design Qualification （DQ） 12.2 Installation Qualification （IQ） 12.3 Operational Qualification （OQ） 12.4 Performance Qualification （PQ） 12.5 Re-qualification 12.6 Qualification report13. Process validation13.1 Prospective validation 13.2 Concurrent validation 13.3 Retrospective va

11、lidation14. Computer validation14.1 General 14.2 System specification 14.3 Functional specification 14.4 Security 14.5 Back-ups 14.6 Validation 14.7 Validation of hardware and software14.7.1 Hardware14.7.2 Software15. Analytical validation15.1 General 15.2 Pharmacopoeia methods 15.3 Non-pharmacopoei

12、a methods 15.4 Method validation 15.5 Validation report 15.6 Characteristics of analytical procedures16. Cleaning validation16.1 General 16.2 Sampling 16.3 Analytical methods 16.4 Evaluation17. Re-validation17.1 Periodic re-validation 17.2 Re-validation after changes18. Change control19. Personnel 1

13、9 19 20 20 21 21 21 21 22 23 24 24 24 25 26 26 26 26 27 28 29 29 29 29 30 30 30 33 33 35 37 41 42 43 43 44 44References Working document QS/03.055/Rev.1 page 5 4647 Annex: Format for an Installation Qualification Protocol and Report1. INTRODUCTIONValidation is an essential and integral part of Good

14、Manufacturing Practice （GMP）.It is, therefore, an element of the quality assurance programme associated with a particular product or process. It is accepted that the basic principles of quality assurance have as their goal the production of products that are fit for their intended use. These princip

15、les may be stated as:（1） quality, safety and efficacy must be designed and built into the product;（2） quality cannot be inspected or tested into the finished product; and（3） each step of the manufacturing process must be controlled to maximize theprobability that the finished product meets all quality and design specifications.Validation of processes and systems is fundamenta