Pharmaceutical Quality Assurance Notes

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pharmaceutical quality assurance notes

Dowwnload Pharmaceutical Quality Assurance Notes pdf 6 semester

Here in the pharmaceutical quality assurance notes pdf , you will get the following chapters and other chapters will be provided soon…So follow us here and also our other social media platforms links Given below.

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We also provide you with pharmaceutical quality assurance MCQ pdf question papers and other important things like b pharm books , b pharm previous year question paper related to the university and other exams like GPAT, NIPER, RRB, and DI exams.


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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


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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.

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Quality Control: Quality control test for containers, rubber closures and secondary packing
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 Facilit


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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.

Other Subjects Notes Given below :

  • Pharmacology 3 Click
  • Medicinal Chemistry 3 Click
  • Herbal Drug Technology Click
  • Biopharmaceutics & pharmacokinetics Click
  • Pharmaceutical Biotechnology Click
  • Pharmaceutical Quality Assurance Click


N.B-We are providing Different notes below.Download as your choice

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 managemen

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