Curriculum
- 5 Sections
- 29 Lessons
- 16 Weeks
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- UNIT-I9
- 1.1Overview of Pharmaceutical Industry.Copy
- 1.2Introduction to different departments and their roles and Good Industrial Practices.Copy
- 1.3Facilities and Equipment system overviewCopy
- 1.4Manufacturing process, unit operation, Packing and labelling of Dosage Forms (Tablets, Capsules, Liquid Orals, Injectable Semisolids/Ointments)Copy
- 1.5Quality Assurance- Role and responsibilitiesCopy
- 1.6In-process checking /samplingsCopy
- 1.7Quality ControlCopy
- 1.8IPQC test: Dissolution test, DT, Friability, Drug contents determination, Moisture contents of granules, Weight variation of uncoated tablets, Hardness testCopy
- 1.9Different types of document s and their usesCopy
- UNIT-II5
- 2.1Overview of basic skills and importance of a Chemist- Production (Pharma, Cosmetics & Biologics) in a Non-Sterile product manufacturing processCopy
- 2.2Introduction of functional and cross-functional stakeholders for Chemist – Production (Pharma, Cosmetics & Biologics)Copy
- 2.3Various communication methods (verbal and written) for reporting incidents/ deviations. Strategies for manpower management and optimization of team productivityCopy
- 2.4Introduction of various type of audits in the life sciences sector for the manufacturing operations.Copy
- 2.5Introduction of the Sexual Harassment of Women at Workplace (Prevention, Prohibition, and Redressed) Act and the provided penalties for violation at workplaceCopy
- UNIT-III5
- 3.1Importance of Standard operating procedures, equipment master list, and equipment qualification plan for production process.Copy
- 3.2Process of calibration and validation of the equipment and balances used in the manufacturing area.Copy
- 3.3Different types of pre-production checks performed in a production unit.Copy
- 3.4Various troubleshooting methods and solutions for guidance to operators during production activities in consideration of critical process parameters and critical quality attributes.Copy
- 3.5Role of assay and Quantity effect in biopharmaceutical formulation.Copy
- UNIT-IV5
- 4.1Various method of reporting and documentation as per Good Documentation Practices (GDP) and other regulatory guidelines.Copy
- 4.2Introduction of Attributable, Legible, Contemporaneous, Original, and Accurate Plus (ALCOA PLUS) principle and its importance.Copy
- 4.3Overview and introduction of Drug Master File (DMF), Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR).Copy
- 4.4Industrial practices for generation of electronic and manual records in the log-books and other documentation required as per GMP and GDP.Copy
- 4.5Management of Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR) for each intermediate and finished non-sterile product.Copy
- UNIT-V5
- 5.1Introduction to working principle of machines and equipment used for various non-sterile product manufacturing process like tablet, capsule, liquid oral and their calibration and validation process.Copy
- 5.2Introduction of ICH Q7 GMP guidelines for non-sterile product manufacturing.Copy
- 5.3Application of various pharmaceutical and engineering concepts for troubleshooting in manufacturing process related to machines and equipment for tablet, capsule, and liquid orals.Copy
- 5.4Process of cleaning validation for a non-sterile production area and equipment.Copy
- 5.5Concept and procedure of root cause analysis for out-of-specification (OOS) and out-of-trend (OOT) products in case of deviations in production process.Copy
Various communication methods (verbal and written) for reporting incidents/ deviations. Strategies for manpower management and optimization of team productivityCopy
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Introduction of the Sexual Harassment of Women at Workplace (Prevention, Prohibition, and Redressed) Act and the provided penalties for violation at workplaceCopy
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