Curriculum | Pharmaceutical Quality Assurance (Theory) | B. Pharmacy

Course: B Pharmacy -6th Semester/3rd Year
Name of the Subject: Pharmaceutical Quality Assurance (Theory)
Subject Code: BP606T

S. No. Contents of the Topics Learning Objectives Teaching Guidelines Methodology Time
(Hrs)
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 procedure

Upon completion of the course student shall be able to:

describe  the cGMP aspects in a pharmaceutical industry

  • Definition and concept of Quality control, Quality assurance and GMP
  • Total Quality Management (TQM
  • purpose, participants, process of harmonization, Brief overview of QSEM, with special emphasis on Q-series guidelines, ICH stability testing guidelines
  • Tools ISO 9000 & ISO14000Overview, Benefits Elements, steps for registration NABL accreditation : Principles and procedure

Attendance, academic activities like quiz, assignments, open book tests, field work, group discussions , seminar ,presentations, student teacher interactions, practical records, & Viva voce

10

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.

 

Upon completion of the course student shall be able to:

describe  the cGMP aspects in a pharmaceutical industry visit orientation of 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
Attendance, academic activities like quiz, assignments, open book tests, field work, group discussions , seminar ,presentations, student teacher interactions, practical records, & Viva voce

6

Equipments and raw materials: Equipments selection, purchase specifications, maintenance, purchase specifications and maintenance of stores for raw materials. Upon completion of the course student shall be able to:

describe  the cGMP aspects in a pharmaceutical industry w r t equipments and API

  • Equipments selection, purchase
  • Specification
  • maintenance
  • Purchase specifications and maintenance of stores for raw materials.
Attendance, academic activities like quiz, assignments, open book tests, field work, group discussions , seminar ,presentations, student teacher interactions, practical records, & Viva voce

4

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

 

Upon completion of the course student shall be able to:

describe  the Quality control parameters and GLP in a pharmaceutical industry

  • Quality control test for container
  • Rubber closures
  • Secondary packing materials
  • 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
Attendance, academic activities like quiz, assignments, open book tests, field work, group discussions , seminar ,presentations, student teacher interactions, practical records, & Viva voce

10

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.

Upon completion of the course student shall be able to:

describe  the SOP’s and documentations in a pharmaceutical industry

  • Complaints and evaluation of complaints
  • Handling of return good, recalling and waste disposal
  • Batch Formula Record
  • Master Formula Record, SOP
  • Quality audit, Quality Review and Quality documentation
  • Reports and documents distribution records

Attendance, academic activities like quiz, assignments, open book tests, field work, group discussions , seminar ,presentations, student teacher interactions, practical records, & Viva voce

8

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

Upon completion of the course student shall be able to:

describe  the Validation and warehousing in a pharmaceutical industry

  • 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

 

  • Good warehousing practice, materials management

Attendance, academic activities like quiz, assignments, open book tests, field work, group discussions , seminar ,presentations, student teacher interactions, practical records, & Viva voce

7