Pharmaceutical Quality Assurance Notes (S-6)
Pharmaceutical Quality Assurance Notes
Below are well-organized, unit-wise Pharmaceutical Quality Assurance notes available for free.
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Unit 1
Quality Assurance, GMP, ICH, QbD & Quality System
Unit 1 Covers QA, QC, GMP concepts, TQM elements and philosophies, ICH guidelines (QSEM, stability testing), Quality by Design (QbD) tools and elements, ISO 9000/14000 standards and benefits, and NABL accreditation principles and steps.
Unit 2
GMP: Personnel, Premises & Equipment Control
Unit 2 Covers personnel roles, training, hygiene, records; premises design, layout, sanitation, contamination control; and equipment/raw materials—selection, specifications, maintenance, and storage practices
Unit 3
Quality Control and Good Laboratory Practice
Unit 3 Covers QC tests for containers, closures, and packaging; and Good Laboratory Practices (GLP) including personnel, facilities, equipment, operations, study protocols, records, reports, and disqualification criteria.
Unit 4
Complaints & Document Management
This Unit Covers handling and evaluation of complaints, returned goods, recalls, and waste disposal, along with documentation like batch and master formula records, SOPs, audits, reviews, quality docs, reports, and distribution records.
Unit 5
Calibration and Warehousing
Unit 5 Covers calibration, qualification, and validation principles, types, scope, and master plan; calibration of pH meter, UV-Vis qualification, analytical method validation basics, and good warehousing practices with materials management.
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