Principles and Practice of Quality Assurance Detailed Syllabus for Quality Assurance and Pharma Regulatory Affairs M.Pharm first year second sem is covered here. This gives the details about credits, number of hours and other details along with reference books for the course.
The detailed syllabus for Principles and Practice of Quality Assurance M.Pharm 2017-2018 (R17) first year second sem is as follows.
M.Pharm. I Year II Sem.
Course Objective: This subject consists of topics regarding Q.C responsibilities sampling plans retention of samples and provides the distribution procedure and maintenance of records. It practically covers aspects of pharmaceutical processing activities.
Course Outcome: From this subject get the knowledge about documentation &release procedure and the authority of person for Q.C laboratory. Students learn the sample retention, release of finished product for sale &distribution and legal regulations &restriction on using animals in the laboratory. Preparation of sop on distributions.
Quality Management:
UNIT I : Quality control laboratory responsibilities, good laboratory practices, routine controls, instruments, sampling plans, standard test procedures, non clinical testing, controls on animal house, data generation and storage, .
UNIT II: \Ware housing, good ware housing practices materials management. Finished product release, quality review, quality audit. Batch release documents. quality control documentation, retention samples, records, audits of quality control facilities
UNIT III: Distribution and distribution records. Handling of returned goods. Complaints and recalls, evaluation of complaints, recall procedures, related records and documents. Waste disposal, scrap disposal producers and records.
Validation :
UNIT IV : Qualification, validation, and calibration of equipment. Validation of process like mixing , granulation, drying, compression, filtration filling etc. Validation of sterilization methods and equipment, dry heat sterilization, autoclaving, membrane filtration.
UNIT V : Validation and audits of analytical procedures, validation and personnel, validation and security measures for electronic data processing.
RECOMMENDED BOOKS:
- Pharmaceutical Process Validation – Robert A. Nash, Alfred H. Wachter
- Process Validation in manufacturing of biopharmaceuticals: Guidelines – Anurag Singh Rathore, Gail Sofer, G. K. Sofer
- Pharmaceutical Quality Assurance – Mr. Manohar A. Potdar
- Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials (v. 1) by WHO
For all other M.Pharm 1st Year 2nd Sem syllabus go to JNTUH M.Pharm Quality Assurance and Pharma Regulatory Affairs 1st Year 2nd Sem Course Structure for (R17) Batch.
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