PUBLIC HEALTH PHARMACY

PHARMACEUTICAL QUALITY ASSURANCE BP606T

UNIT -01

  • 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 -02

  • 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 -03

 

  • 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 -04

 

  • 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 -05

  • 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.