Pharmaceutical Quality Assurance Notes

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In this article, we will provide you with b pharmacy 6th-semester notes pdf.

 

This pharmaceutical quality assurance notes will help all the B Pharmacy and D Pharmacy students very much to make a good score in their university and any other competitive exams.

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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.

All the b pharmacy handwritten study notes available on this website are prepared by renowned professors from different universities of India. By studying this, you can get very good marks in your board final examination.

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.

Unit-1

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

Unit-2

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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Unit-3

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 Facilit

Unit-4

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

Unit-5

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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