TGA GMP Guidelines For Medicinal Products Part-2 in Telugu

Sathyanarayana M.Sc.
0

షధ ఉత్పత్తుల కోసం TGA GMP మార్గదర్శకాలు 
పార్ట్-2 తెలుగులో:


GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PART-2 in Telugu 
కొరకు క్రింది టైటిల్స్ పైన క్లిక్ చేయండి


Developed by the International Conference on Harmonisation (ICH) of
Technical Requirements for Registration of Pharmaceuticals for Human Use



TABLE OF CONTENTS 



1.  INTRODUCTION   

1.1  Objective 

1.2  Scope 


2.  QUALITY MANAGEMENT 

2.1  Principles 

2.2  Responsibilities of the Quality Unit(s) 

2.3  Responsibility for Production Activities

2.4  Internal Audits (Self Inspection) 

2.5  Product Quality Review


3.  PERSONNEL 

3.1  Personnel Qualifications 

3.2  Personnel Hygiene 


3.3  Consultants 


4.  BUILDINGS AND FACILITIES 

4.1  Design and Construction 

4.2  Utilities 

4.3  Water 

4.4  Containment 

4.5  Lighting 


4.6  Sewage and Refuse 


4.7  Sanitation and Maintenance 


5.  PROCESS EQUIPMENT 

5.1  Design and Construction 

5.2  Equipment Maintenance and Cleaning 

5.3  Calibration 


5.4  Computerized Systems 


6.  DOCUMENTATION AND RECORDS 

6.1  Documentation System and Specifications 

6.2  Equipment Cleaning and Use Record 

6.3  Records of Raw Materials, Intermediates, API Labeling and Packaging Materials

6.4  Master Production Instructions (Master Production and Control Records) 

6.5  Batch Production Records (Batch Production and Control Records) 

6.6  Laboratory Control Records 

6.7  Batch Production Record Review 


7.  MATERIALS MANAGEMENT 

7.1  General Controls 

7.2  Receipt and Quarantine 

7.3  Sampling and Testing of Incoming Production Materials 

7.4  Storage 

7.5  Re-evaluation 


8.  PRODUCTION AND IN-PROCESS CONTROLS 

8.1  Production Operations 

8.2  Time Limits 

8.3  In-process Sampling and Controls 

8.4  Blending Batches of Intermediates or APIs 

8.5  Contamination Control 



9.  PACKAGING AND IDENTIFICATION LABELING OF APIS AND INTERMEDIATES 

9.1  General 

9.2  Packaging Materials 

9.3  Label Issuance and Control 

9.4  Packaging and Labeling Operations 


10.  STORAGE AND DISTRIBUTION 

10.1  Warehousing Procedures 

10.2  Distribution Procedures 


11.  LABORATORY CONTROLS 

11.1  General Controls 

11.2  Testing of Intermediates and APIs

11.3  Validation of Analytical Procedures - See Section - 12  

11.4  Certificates of Analysis 

11.5  Stability Monitoring of APIs 

11.6  Expiry and Retest Dating 

11.7  Reserve/Retention Samples 



12.  VALIDATION 

12.1  Validation Policy 

12.2  Validation Documentation 

12.3  Qualification 

12.4  Approaches to Process Validation 

12.5  Process Validation Program 

12.6  Periodic Review of Validated Systems 

12.7  Cleaning Validation 

12.8  Validation of Analytical Methods 



13.   CHANGE CONTROL 


14.  REJECTION AND RE-USE OF MATERIALS 

14.1   Rejection

14.2   Reprocessing 

14.3   Reworking 

14.4   Recovery of Materials and Solvents 

14.5   Returns 


15.  COMPLAINTS AND RECALLS 


16.  CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)


17.  AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS 

17.1  Applicability 

17.2  Traceability of Distributed APIs and Intermediates 

17.3  Quality Management 

17.4  Repackaging, Relabelling and Holding of APIs and Intermediates 

17.5  Stability 

17.6  Transfer of Information 


17.7  Handling of Complaints and Recalls

17.8  Handling of Returns 



18.  SPECIFIC GUIDANCE FOR APIS MANUFACTURED BY CELL      CULTURE/FERMENTATION 

18.1  General

18.2  Cell Bank Maintenance and Record Keeping 

18.3  Cell Culture/Fermentation 

18.4  Harvesting, Isolation and Purification 

18.5  Viral Removal/Inactivation steps 



19.  APIS FOR USE IN CLINICAL TRIALS 

19.1  General 

19.2  Quality 

19.3  Equipment and Facilities 

19.4  Control of Raw Materials 

19.5  Production 

19.6  Validation 

19.7  Changes 

19.8  Laboratory Controls 

19.9  Documentation 


20.  GLOSSARY  


TGA GMP Guidelines For Medicinal Products Part-2 in Telugu

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