US FDA Drug Manufacturing Inspections Guidelines in Telugu | PROGRAM 7356.002
US FDA Drug Manufacturing Inspections Guidelines in Telugu
కొరకు క్రింది టైటిల్స్ పై క్లిక్ చేయండి.
Table of Content
PART I - BACKGROUND in Telugu
PART II- IMPLEMENTATION in Telugu
OBJECTIVES in Telugu
STRATEGY in Telugu
A. Inspection of Manufacturing Establishments (includes repackaging, contract labs, etc.)
B. Inspection of Systems
C. A Scheme of Systems for the Manufacture of Drugs/Drug Products
1) Quality System
2) Facilities and Equipment System
3) Materials System
4) Production System
5) Packaging and Labeling System
6) Laboratory Control System
PROGRAM MANAGEMENT INSTRUCTIONS in Telugu
A. Definitions
1. Surveillance Inspections
2. For-Cause Inspections
3. State of Control
4. Drug Process
5. Drug Manufacturing Inspection
B. Inspection Planning
C. Profiles
PART III – INSPECTIONAL
INVESTIGATIONAL OPERATIONS
A. General
B. Inspection Approaches
1. Selecting the Full Inspection Option
2. Selecting the Abbreviated Inspection Option
- Inspection Coverage
C. System Inspection Coverage
QUALITY SYSTEM
FACILITIES AND EQUIPMENT SYSTEM
MATERIALS SYSTEM
PRODUCTION SYSTEM
PACKAGING AND LABELING SYSTEM
LABORATORY CONTROL SYSTEM
D. Sampling
E. Inspection Teams
F. Reporting
PART IV - ANALYTICAL
ANALYZING LABORATORIES
SERVICING LABORATORY
ANALYSIS
PART V - REGULATORY/ADMINISTRATIVE STRATEGY
Quality System
Facilities and Equipment
Materials System
Production System
Packaging and Labeling
Laboratory System
PART VI – REFERENCES, ATTACHMENTS, AND PROGRAM CONTACTS
PART VII - CDER AND ORA RESPONSIBILITIES OVERVIEW
Surveillance Inspection Responsibilities:
For-Cause Inspection Responsibilities:
US FDA Drug Manufacturing Inspections Guidelines in Telugu:
