FDA Investigations Operations Manual(检查操作手册2015年）

beiwei5du

FDA Investigations Operations Manual(检查操作手册）http://www.fda.gov/ICECI/Inspections/IOM/default.htm

CONTENTS 2015

CHAPTER 1 -ADMINISTRATION
SUBCHAPTER 1.1 ENGLISH LANGUAGE REQUIREMENT FOR FDA DOCUMENTS
SUBCHAPTER 1.2 TRAVEL
SUBCHAPTER 1.3 LEAVE
SUBCHAPTER 1.4 DISCLOSURE OF OFFICIAL INFORMATION
SUBCHAPTER 1.5 SAFETY
SUBCHAPTER 1.6 PUBLIC RELATIONS, ETHICS & CONDUCT
SUBCHAPTER 1.7 INTERDISTRICT ASSIGNMENTS
SUBCHAPTER 1.8 ORGANIZATION OVERVIEW
SUBCHAPTER 1.9 OFFICE OF REGULATORY AFFAIRS
SUBCHAPTER 1.10 REFERENCES

CHAPTER 2 -REGULATORY
SUBCHAPTER 2.1 REGULATORY NOTES
SUBCHAPTER 2.2 STATUTORY AUTHORITY
SUBCHAPTER 2.3 RECONDITIONING AND DESTRUCTION
SUBCHAPTER 2.4 CONSENT DECREE
SUBCHAPTER 2.5 DEFAULT DECREE
SUBCHAPTER 2.6 COMPLIANCE ACHIEVEMENT
SUBCHAPTER 2.7 DETENTION ACTIVITIES
SUBCHAPTER 2.8 DENATURING
SUBCHAPTER 2.9 REGULATORY SUBMISSIONS

CHAPTER 3 -FEDERAL AND STATE COOPERATION
SUBCHAPTER 3.1 COOPERATIVE EFFORTS
SUBCHAPTER 3.2 FEDERAL AGENCY INTERACTION
SUBCHAPTER 3.3 STATE OPERATIONAL AUTHORITY
SUBCHAPTER 3.4 INTERNATIONAL AGREEMENTS
SUBCHAPTER 3.5 NON GOVERNMENT AGREEMENTS

CHAPTER 4 -SAMPLING
SUBCHAPTER 4.1 GENERAL
SUBCHAPTER 4.2 DEALER RELATIONS
SUBCHAPTER 4.3 COLLECTION TECHNIQUE
SUBCHAPTER 4.4 DOCUMENTATION & CR
SUBCHAPTER 4.5 SAMPLING: PREPARATION, HANDLING, SHIPPING

CHAPTER 5 -ESTABLISHMENT INSPECTIONS
SUBCHAPTER 5.1 INSPECTION INFORMATION
SUBCHAPTER 5.2 INSPECTION PROCEDURES
SUBCHAPTER 5.3 EVIDENCE DEVELOPMENT
SUBCHAPTER 5.4 FOOD
SUBCHAPTER 5.5 DRUGS
SUBCHAPTER 5.6 DEVICES
SUBCHAPTER 5.7 BIOLOGICS
SUBCHAPTER 5.8 TOBACCO PRODUCTS
SUBCHAPTER 5.9 VETERINARY MEDICINE
SUBCHAPTER 5.10 REPORTING

CHAPTER 6 -IMPORTS
SUBCHAPTER 6.1 IMPORTS
SUBCHAPTER 6.2 IMPORT PROCEDURES
SUBCHAPTER 6.3 REVIEW OF RECORDS
SUBCHAPTER 6.4 FIELD EXAMINATION
SUBCHAPTER 6.5 IMPORT SAMPLE COLLECTION
SUBCHAPTER 6.6 FILER EVALUATIONS
SUBCHAPTER 6.7 GLOSSARY OF IMPORT TERMS

CHAPTER 7 -RECALL ACTIVITIES
SUBCHAPTER 7.1 RECALLS
SUBCHAPTER 7.2 RECALL NOTIFICATION / INSPECTION
SUBCHAPTER 7.3 MONITORING RECALLS
SUBCHAPTER 7.4 SPECIAL RECALL SITUATIONS

CHAPTER 8 -INVESTIGATIONS
SUBCHAPTER 8.1 INVESTIGATIONS
SUBCHAPTER 8.2 COMPLAINTS
SUBCHAPTER 8.3 INVESTIGATION OF FOODBORNE OUTBREAKS
SUBCHAPTER 8.4 INVESTIGATION - INJURY & ADVERSE REACTION
SUBCHAPTER 8.5 DISASTER PROCEDURES
SUBCHAPTER 8.6 SURVEILLANCE
SUBCHAPTER 8.7 INVESTIGATIONAL RESEARCH
SUBCHAPTER 8.8 COUNTERFEITING / TAMPERING
SUBCHAPTER 8.9 OFFICE OF CRIMINAL INVESTIGATION (OCI)
SUBCHAPTER 8.10 GENERAL INVESTIGATION REPORTING


APPENDIX
INDEX
ORA DIRECTORY

张丽娜

meiya 发表于 2015-10-17 12:33
是FDA检查官用的SOP么？

从前言中第一段话的内容看，是的

张丽娜

不错，谢谢分享。如果有中文对照版就好了

meiya

是FDA检查官用的SOP么？

胜利者

抢个座位

syhorchid

抢沙发