Quality Assurance Book B.Pharm 6th Semester

Syllabus

Module 01                                                                                          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 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.

Module 02                                                                                          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.

Module 03                                                                                          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.

Module 04                                                                                          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.

Module 05                                                                                          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.