BP606T. PHARMACEUTICAL QUALITY ASSURANCE Books : PharmaLite.in

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BP606T. PHARMACEUTICAL QUALITY ASSURANCE Books



All books are given below after syllabus

Unit-I 

Quality Assurance and Quality Management concepts: Definition and concept of Quality control, Quality assurance and GMP. 

Total Quality Management (TQM): Definition, elements, philosophies. 

ICH Guidelines: purpose, participants, process of harmonization, Brief overview of QSEM, with special emphasis on Q-series guidelines, ICH stability testing guidelines. 

Quality by design (QbD): Definition, overview, elements of QbD program, tools.  

ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration.  NABL accreditation: Principles and procedures. 


Unit-II 

Organization and personnel: Personnel responsibilities, training, hygiene and personal records. Premises:  Design, construction and plant layout, maintenance, sanitation, environmental control, utilities and maintenance of sterile areas, control of contamination. 

Equipments and raw materials: Equipment selection, purchase specifications, maintenance, purchase specifications and maintenance of stores for raw materials. 

 

 

Unit-III 

Quality Control: Quality control test for containers, rubber closures and secondary packing materials. 

Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities, Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of a Nonclinical Laboratory Study, Records and Reports, Disqualification of Testing Facilities. 


Unit-IV

Complaints: Complaints and evaluation of complaints, Handling of return good, recalling and waste disposal. 

Document maintenance in pharmaceutical industry: Batch Formula Record, Master Formula Record, SOP, Quality audit, Quality Review and Quality documentation, Reports and documents, distribution records. 


Unit-V  

Calibration and Validation: Introduction, definition and general principles of calibration, qualification and validation, importance and scope of validation, types of validation, validation master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical method Validation. 

Warehousing: Good warehousing practice, materials management. 



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