JNTUK B.Tech Quality Assurance, GMP, GLP gives you detail information of Quality Assurance, GMP, GLP R13 syllabus It will be help full to understand you complete curriculum of the year.
UNIT – I : Concept of Quality assurance, philosophy of GMP, CGMP and GLP.
LO : To understand Concept of Quality assurance, philosophy of GMP, CGMP and GLP.
UNIT – II : Organization and personnel, responsibilities, training hygiene – Premises: Location, design, plant layout, construction, maintenance and sanitations, environmental control, sterile areas, control of contamination.
LO : To understand organization and personnel, responsibilities, training hygiene – Premises: Location, design, plant layout, construction, maintenance and sanitations, environmental control, sterile areas, control of contamination.
UNIT – III : Equipments: Selection, purchase specifications, maintenance, clean in place, sterilize in place – Raw materials: Purchase specifications, maintenance of stores, selection of vendors, controls and raw materials.
LO : To understand selection, purchase specifications, maintenance, clean in place, sterilize in place – Raw materials: Purchase specifications, maintenance of stores, selection of vendors, controls and raw materials.
UNIT – IV : Manufacture and controls on dosage forms, manufacturing documents master formula, batch formula records, standard operating procedures, quality audits of manufacturing processes and facilities – In process quality control on various dosage forms: sterile, biological products and non-sterile, standard operating procedures for various operations like cleaning, filling, drying, compression, coating. Packaging and labeling controls.
LO : To understand manufacture and controls on dosage forms, manufacturing documents master formula, batch formula records, standard operating procedures, quality audits of manufacturing processes and facilities – In process quality control on various dosage forms: sterile, biological products and non-sterile, standard operating procedures for various operations. Packaging and labeling controls.
UNIT – V : Quality Control Laboratory: Responsibilities, good laboratory practices, routine controls, instruments, protocols, non-clinical testing, controls on animal house, data generation and storage, quality control documents, retention samples, records, audits of quality control facilities – Finished products release: quality review, quality audits and batch release document.
LO : To understand responsibilities, good laboratory practices, routine controls, instruments, protocols, non-clinical testing, controls on animal house, data generation and storage, quality control documents, retention samples, records, audits of quality control facilities -Finished products release: quality review, quality audits and batch release document.
UNIT – VI : Distribution and Distribution records: Handling of returned goods, recovered materials and reprocessing Complaints and recalls, evaluation of complaints, recall procedures, related records and documents.
LO : To understand handling of returned goods, recovered materials and reprocessing. Complaints and recalls, evaluation of complaints, recall procedures, related records and documents.
TEXT BOOKS
- The International Pharmacopoeia Vol. 1,2,3,4, 3rd edition General methods of analysis quality specifications for Pharmaceutical substances, Excipients, dosage forms.
- Quality Assurance of Pharmaceuticals: A compendium of guidelines and related material Vol. 1 and Vol. 2., WHO, (1999).
- GMP-Mehra.
- Pharmaceutical Process validation by Berry and Nash
REFERENCE BOOKS
- Basic tests for Pharmaceutical substances – WHO (1988 &1991)
- How to practice GMP’s – P.P.Sharma
- The Drugs and Cosmetic Act 1940- Vijay Malik.
- Q.A Manual by D.H.Shah.
- SOP Guidelines by D.H.Shah.
- Quality Assurance Guide by OPPI.
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