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Quality Assurance Book B.Pharm 6th Semester

Quality Assurance Book B.Pharm 6th Semester

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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.

 

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