Glass Buildings
Search

PHARMACEUTICAL QUALITY ASSURANCE (Theory)


UNIT – I


1. Quality Assurance and Quality Management concepts:




UNIT – II










UNIT – III







UNIT – IV






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











Second material




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 personalrecords.

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



#pharmacycollege #india


#pharmaceuticalqualityassurance #pharmacy #bpharm #pcisyllabus










0 comments