BP606T PHARMACEUTICAL QUALITY ASSURANCE | Raghu College Of Pharmacy

About Course

Scope: This course deals with the various aspects of quality control and quality
assurance aspects of pharmaceutical industries. It deals with the important aspects like
cGMP, QC tests, documentation, quality certifications and regulatory affairs.
Objectives: Upon completion of the course student shall be able to:  understand the cGMP aspects in a pharmaceutical industry
 appreciate the importance of documentation
 understand the scope of quality certifications applicable to pharmaceutical
industries  understand the responsibilities of QA & QC departments

Course Content

UNIT – I
1.1 Quality Assurance and Quality Management concepts 1.2 Total Quality Management (TQM) 1.3 ICH Guidelines 1.4 Quality by design (QbD) 1.5 ISO 9000 & ISO14000

UNIT -II
2.1 Organization and personnel 2.2 Premises 2.3 Equipments and raw materials

UNIT – III
3.1 Quality Control 3.2 Good Laboratory Practice

UNIT – IV
4.1 Complaints 4.2 Document maintenance in pharmaceutical industry

UNIT – V
5.1 Calibration and Validation 5.2 Warehousing

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About Course

Course Content

UNIT – I 1.1 Quality Assurance and Quality Management concepts 1.2 Total Quality Management (TQM) 1.3 ICH Guidelines 1.4 Quality by design (QbD) 1.5 ISO 9000 & ISO14000

UNIT -II 2.1 Organization and personnel 2.2 Premises 2.3 Equipments and raw materials

UNIT – III 3.1 Quality Control 3.2 Good Laboratory Practice