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Pharmaceutical Production

    Operational procedures of the Production, Quality Control, and Quality Assurance departments. Validations, Process Validation, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) of different equipment.

   In-process sampling, Batch Manufacturing Record (BMR), Batch Production Record (BPR), International Council for Harmonisation (ICH) rules, audits, Attributable, Legible, Contemporaneous, Original, Accurate (ALCOA), and ALCOA Plus.

Issues pertaining to data integrity, Management of occurrences such as Out of Specification (OOS), Out of Trend (OOT), deviations, and change control. Total Quality Management and Quality Risk Management Calibration of several instruments. Practical experience with numerous equipment, including pH meter, analytical balance, dissolution tester apparatus, Karl Fischer titrator, HPLC, UV and IR spectrometers, and gas chromatography, in pharmaceutical product analysis. Proficiency with all HPLC software. Preparation of interviews, Guest lectures of field experts, Lifetime advantages for alumni.

Course Outcomes:-

1. Pharmaceutical production principles and technologies

2.Good Manufacturing Practices (GMP) and regulatory guidelines

3. Quality control and assurance methodologies

4.Process validation and optimization strategies

5.Supply chain management in pharmaceutical production

6.Hands-on training in operating pharmaceutical machinery and equipment

7. Simulation of production processes and troubleshooting exercises

8.Internships in pharmaceutical manufacturing companies

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