SYLLABUS OF PHARMACEUTICAL QUALITY ASSURANCE (Theory) :-

                                          SUBJECT :-

             PHARMACEUTICAL QUALITY ASSURANCE 

                          (SUB CODE- BP606T , VI th sem ,Bpharm, PCI )

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  :-                                                                                                                 10 Hours 

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 stabilitytesting 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 :-                                                                                                                      10 Hours 

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:-                                                                                                                       10 Hours 

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 :-                                                                                                                         08 Hours

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:-                                                                                                                           07 Hours

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