Pharmaceutical Quality Assurance (Theory) BP606T Sem 6 | Download Free Pharmacy Notes PDFs | Handwritten Notes for Pharmacy Students
Welcome to The Future Pharmacist,here you will get all important notes of Pharmaceutical Quality Assurance (Theory) both handwritten and typed.we also provide you all important mcqs question papers and other important things related to the university and other exams like GPAT,NIPER,RRB and DI exam
Here in Pharmaceutical Quality Assurance (Theory),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.
If you have any problems regarding downloading PDFs Contact us on our social media pages
Follow us on :-
Telegram Job-related updates:- Click here
Facebook:- Click here
Instagram:- Click here
Youtube:- Click here
Telegram:- Click here
Facebook:- Click here
Instagram:- Click here
Youtube:- Click here
Telegram:- Click here
Download Semester wise PDFs,MCQs and Notes :-
Semester 1 :- Click here
Semester 2 :- Click here
Semester 3 :- Click here
Semester 4 :- Click here
Semester 5 :- Click here
Semester 6 :- Click here
Semester 7 :- Click here
Semester 8 :- Click here
Semester 1 :- Click here
Semester 2 :- Click here
Semester 3 :- Click here
Semester 4 :- Click here
Semester 5 :- Click here
Semester 6 :- Click here
Semester 7 :- Click here
Semester 8 :- Click here
Check following Syllabus:-
UNIT – I
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
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 - II
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.
UNIT – III
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
UNIT – IV
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.
UNIT – V
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
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.
UNIT – III
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
UNIT – IV
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.
UNIT – V
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
Download Following Chapters:-
UNIT – IQuality 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
Download (Optional Link)
UNIT - II
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.
Download (Optional Link)
UNIT – III
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
Download (Optional Link)
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.
Download (Optional Link)
UNIT – V
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
Check other important MCQs :-
MCQs From Hospital and Clinical Pharmacy(include all chapters): Click here
MCQs on Introduction of Glycosides:-Click here
MCQs on Introduction of pharmacognosy :- Click here
Download and Read B pharmacy MCQs :- Click here
MCQs on Introduction of Lipids and Resins:Click here
MCQs From Pharmaceutical Engineering (include all chapters):- Click here
MCQs From Biopharmaceutics and Pharmacokinetics (include all chapters) :- Click here
MCQs From Tablet chapter :- Click here
MCQs From Pharmaceutical Jurisprudence (include all chapters):-Click here
MCQs on Introduction of Alkaloids:- Click here
Human Anatomy and Physiology-I :- Click here
MCQs on Introduction of Volatile Oils:-Click Here
MCQs From Pathophysiology (include all chapters):-Click here
Check other important Question Papers:- Click here
If you need additional notes/MCQs/Question paper please comment below or if you need any information related to Pharmacy field kindly contact us or follows us on our social media accounts
Follow us on:-
Telegram Job-related updates:- Click here
Facebook:- Click here
Instagram:- Click here
Youtube:- Click here
Telegram:- Click here
Telegram Job-related updates:- Click here
Facebook:- Click here
Instagram:- Click here
Youtube:- Click here
Telegram:- Click here
Sir please upload subject quality assurance mcqs
ReplyDeletethanku sir
ReplyDeleteMost Welcome Dear !!!
DeleteThanks a lot
ReplyDeleteMost Welcome Dear !!
DeleteCould you please tell me where can I find MCQ for quality assurance subject
ReplyDelete