Elective Subject book, notes pdf - b pharmacy 3rd year (6th semester) - JNTUH

 Elective Subject

(Pharmaceutical Quality Assurance, Pharmaceutical Biotechnology, Bioinformatics, Screening Methods in Pharmacology)

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B Pharmacy 3rd year (2nd sem) | 6th Semester | JNTUH

Pharmaceutical Quality Assurance

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 procedure

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
Equipments selection, purchase specifications, maintenance, purchase specifications and maintenance of stores for raw materials. 

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 Facilities.

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.

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 management

Pharmaceutical Biotechnology

Unit -1

Brief introduction to Biotechnology with reference to Pharmaceutical Sciences.

Enzyme Biotechnology- Methods of enzyme immobilization and applications.

Biosensors- Working and applications of biosensors in Pharmaceutical Industries.

Brief introduction to Protein Engineering.

Use of microbes in industry. Production of Enzymes- General consideration - Amylase, Catalase, Peroxidase, Lipase, Protease, Penicillinase.

Basic principles of genetic engineering.

Unit - 2

Study of cloning vectors, restriction endonucleases and DNA ligase.

Recombinant DNA technology. Application of genetic engineering in medicine.

Application of r DNA technology and genetic engineering in the products:

Interferon b) Vaccines- hepatitis- B

Hormones- Insulin. e. Brief introduction to PCR

Types of immunity- humoral immunity, cellular immunity  

Unit - 3

Structure of Immunoglobulins

Structure and Function of MHC

Hypersensitivity reactions, Immune stimulation and Immune suppressions.

General method of the preparation of bacterial vaccines, toxoids, viral vaccine, antitoxins, serum-immune blood derivatives and other products relative to immunity.

Storage conditions and stability of official vaccines

Hybridoma technology- Production, Purification and Applications  

Unit - 4

Immuno blotting techniques- ELISA, Western blotting, Southern blotting.

Genetic organization of Eukaryotes and Prokaryotes

Microbial genetics including transformation, transduction, conjugation, plasmids and transposons.

Introduction to Microbial biotransformation and applications.

Mutation. 

Unit - 5

Types of mutation/mutants

Fermentation methods and general requirements, study of media, equipments, sterilization methods, aeration process, stirring.

Large scale production fermenter design and its various controls.

Study of the production of - penicillins, citric acid, Vitamin B12, Glutamic acid, Griseofulvin, 

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