BP606T: Pharmaceutical Quality Assurance- Theory Syllabus for B.Pharm 6th Sem 2019 Pattern Mumbai University

Pharmaceutical Quality Assurance- Theory detailed Syllabus Scheme for Bachelor of Pharmacy (B.Pharm), 2019 regulation has been taken from the University of Mumbai official website and presented for the Pharmacy students. For Course Code, Subject Name, Continuous Mode, SE Marks, SE Duration, Total, Marks, Duration in Hours, Total Marks, and other information, do visit full semester subjects post given below.

For all other Mumbai University B.Pharm 6th Sem Syllabus 2019 Pattern, do visit B.Pharm 6th Sem 2019 Pattern Scheme. The detailed syllabus scheme for pharmaceutical quality assurance- theory is as follows.

BP606T: Pharmaceutical Quality Assurance- Theory Syllabus for B.Pharm 6th Sem 2019 Pattern Mumbai University

Scope:

For the complete Syllabus, results, class timetable, and many other features kindly download the iStudy App
It is a lightweight, easy to use, no images, and no pdf platform to make students’s lives easier.
.

Objectives

Upon completion of the course student shall be able to:

1. understand the cGMP aspects in a pharmaceutical industry
2. appreciate the importance of documentation
3. understand the scope of quality certifications applicable to pharmaceutical industries
4. understand the responsibilities of QA & QC departments

UNIT I 10

1. Quality Assurance and Quality Management concepts: Definition and concept of Quality control, Quality assurance and GMP 4
2. Total Quality Management (TQM): Definition, elements, philosophies 2
3. ICH Guidelines: purpose, participants, process of harmonization, Brief overview of QSEM,with special emphasis on Q-series guidelines, ICH stability testing guidelines 2
4. QbD: Definition, overview, elements of QbD program, tools ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration 1
5. NABL accreditation : Principles and procedure 1

UNIT II 10

For the complete Syllabus, results, class timetable, and many other features kindly download the iStudy App
It is a lightweight, easy to use, no images, and no pdf platform to make students’s lives easier.
.

UNIT III 10

1. Quality Control: Quality control test for containers, rubber closures and secondary packing materials 5
2. 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 08

1. Complaints: Complaints and evaluation of complaints, Handling of return good, recalling andwaste disposal. 2
2. Document maintenance in pharmaceutical industry: Batch Formula Record, Master Formula Record, SOP, Quality audit, Quality Review and Quality documentation, Reports and documents, distribution records. 6

UNIT V 07

For the complete Syllabus, results, class timetable, and many other features kindly download the iStudy App
It is a lightweight, easy to use, no images, and no pdf platform to make students’s lives easier.
.

Reference Books (Latest Editions to be adopted)

1. Quality Assurance Guide by organization of Pharmaceutical Products of India.
2. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69
3. Quality Assurance of Pharmaceuticals- A compendium of Guide lines and Related materials Vol I WHO Publications.
4. A guide to Total Quality Management- Kushik Maitra and Sedhan K Ghosh
5. How to Practice GMPs – P P Sharma.
6. ISO 9000 and Total Quality Management – Sadhank G Ghosh
7. The International Pharmacopoeia – Vol I, II, III, IV- General Methods of Analysis and Quality specification for Pharmaceutical Substances, Excipients and Dosage forms
8. Good laboratory Practices – Marcel Deckker Series
9. ICH guidelines, ISO 9000 and 14000 guidelines

For detail syllabus of all other subjects of Bachelor of Pharmacy (B.Pharm), 2019 regulation do visit B.Pharm 6th Sem Subjects syllabus for 2019 regulation.