Regulatory requirements in Pharmaceutical Industries detailed syllabus for Pharmacy (Pharma) for 2021 regulation curriculum has been taken from the Anna University official website and presented for the Pharma students. For course code, course name, number of credits for a course and other scheme related information, do visit full semester subjects post given below.
For Pharmacy 7th Sem scheme and its subjects, do visit Pharma 7th Sem 2021 regulation scheme. The detailed syllabus of regulatory requirements in pharmaceutical industries is as follows.
Course Objectives:
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Unit I
REGULATORY CONCEPTS 9
Quality assurance – Quality control – Practice of cGMP – WHO Guidelines – Schedule M – USFDA.
Unit II
REGULATORY ASPECTS 9
Pharmaceuticals: Bulk drug manufacture; Personnel, Buildings and Facilities, Process Equipment, Documentation and Records, Materials Management, Production and In-Process Controls, Packaging and Identification Labelling of API’s and Intermediates, Storage and distribution, – Biotechnology derived products; Principles, Personnel, Premises and equipments, Animal quarters and care, production, labelling, Lot processing records and distribution records, quality assurance and quality control.
Unit III
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Unit IV
ICH GUIDELINES 9
Quality guidelines – Impurities in new drug substances (Q3A(R2)) – Impurities in new drug products(Q3B(R2)) – Validation of analytical procedures text and methodology (Q2 (R1)).
Unit V
QUALITY AUDIT AND SELF INSPECTIONS 9
SOPs – Documentation – Loan license auditing – Common technical documentation (CTD) – Drug master file (DMF) – Batch manufacturing record (BMR).
Course Outcomes:
The student will be able to
- Familiarize with the pharmaceutical industry manufacturing practices and regulatory
- Implement and judge the requirements of regulatory agencies for the pharmaceutical
- Understand the process of patenting activities.
- Know the quality guidelines followed for pharmaceutical products and few of the aspects involved in document preparation for pharmaceutical product registration
- Aware about the technical process of quality audit and inspections.
- Fulfill the regulatory requirements for pharmaceutical products
Text Books:
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Reference Books:
- Ira R. Berry,The Pharmaceutical Regulatory Process, marcel dekker Series: Drugs and the Pharmaceutical Sciences, by CRC Press, Newyork, 2004.
- Mindy J. Allport-Settle, Current Good Manufacturing Practices: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference, Pharmalogika Inc., USA, 2009.
- Willig, H., Tuckeman, M.M. and Hitchings, W.S., “Good Manufacturing Practices for Pharmaceuticals”, 5th Edition, Marcel Dekker Drugs and the Pharmaceutical Sciences, by CRC Press, New York, 2000.
For detailed syllabus of all other subjects of Pharmacy, 2021 regulation curriculum do visit Pharma 7th Sem subject syllabuses for 2021 regulation.
For all Pharmacy results, visit Anna University Pharma all semester results direct link.