US FDA Drug Manufacturing Inspections Guidelines in Telugu

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

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