Pharmaceutical Quality Assurance Notes PDF:

Unit 1

Quality Assurance and Quality Management concepts: Definition and concept of Qualitycontrol, 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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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 material

Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities, Equipment, Testing Facilities Operation, and Control Articles, Protocol for Conduct of aNonclinical Laboratory Study, Records and Reports, Disqualification of Testing Facilities

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Unit 4

Evaluation of Drugs WHO & ICH guidelines for the assessment of herbal drugs
Stability testing of herbal drugs. Patenting and Regulatory requirements of natural products:
a) Definition of the terms: Patent, IPR, Farmers right, Breeder’s right, Bioprospecting and
Biopiracy
b) Patenting aspects of Traditional Knowledge and Natural Products. Case study of Curcuma
& Neem.
Regulatory Issues – Regulations in India (ASU DTAB, ASU DCC), Regulation of
manufacture of ASU drugs – Schedule Z of Drugs & Cosmetics Act for ASU drugs.

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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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Pharmaceutical Quality Assurance 6th Semester Notes PDF:

Theese notes are designed to provide a comprehensive overview of the subject matter, and are an invaluable resource for anyone studying Pharmaceutical Quality Assurance.

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Pharmaceutical Quality Assurance 6th Semester Notes PDF Download

In conclusion, Pharmaceutical Quality Assurance 6th semester notes in PDF format are an excellent resource for anyone studying Pharmaceutical Quality Assurance. They provide a comprehensive overview of the subject matter, and are easily accessible and easy to understand. So if you want to ace your Pharmaceutical Quality Assurance exams, be sure to check them out!

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