Course: MDP in Pharmaceutical Manufacturing Process
Scope: This course enables the student to understand and appreciate the influence of pharmaceutical additives and various pharmaceutical dosage forms on the performance of the drug product. This course also deals with the various aspects of quality control and quality assurance aspects of pharmaceutical industries. It deals with the important aspects like cGMP, QC tests, documentation, quality certifications and regulatory affairs.
Objectives: Upon completion of the course student shall be able to:
⦁ Know the various pharmaceutical dosage forms and their manufacturing and evaluation techniques.
⦁ Understand the cGMP aspects in a pharmaceutical industry.
⦁ Understand the concepts of bioavailability and bioequivalence of drug products and their significance.
⦁ Appreciate the importance of documentation.
⦁ Acquire knowledge of basic analytical instruments used in pharmaceutical industries.
⦁ Understand the responsibilities of QA & QC departments
Course Content
Unit – I (Academic Expert) 1 H
⦁ Basic of Pharmaceutical Dosage Forms – I
Tablets: Introduction, excipients used in manufacturing of tablets, formulation of tablets, granulation methods, tablet coating, defect in tablets and in process and finished product tests
Capsules: Introduction, nature of shell and capsule content, size of capsules, filling, finishing and special techniques of formulation of hard and soft gelatin capsules and in process and final product quality control tests for capsules
Unit – II (Academic Expert) 1 H
⦁ Basic of Pharmaceutical Dosage Forms – II
Parenteral Products: Definition, types, production procedure, container and closure selection, quality control tests of parenteral products
Liquid orals: Formulation and manufacturing consideration of syrups and elixirs suspensions and emulsions
Unit – III (Academic Expert) 1 H
⦁ Basic of Pharmaceutical Dosage Forms – III
Pharmaceutical Aerosols: Definition, propellants, containers, valves, formulation and manufacture of aerosols. Evaluation of aerosols Packaging Material Science: Brief introduction of packaging of pharmaceutical products and quality control tests.
Unit – IV (Industry Expert) 1 H
⦁ Good Manufacturing Practices and Drug Stability Study
Definition, principle and parts of cGMP
ICH guidelines for stability studies of drug substance and drug product
Unit – V (Academic Expert) 1 H
⦁ Bioavailability and Bioequivalence
Definition and Objectives of bioavailability, absolute and relative bioavailability, measurement of bioavailability and in vitro drug dissolution
Unit – VI (Academic Expert) 1 H
⦁ Drug Regulators
Brief introductions and functions of CDSCO and USFDA
Unit – VII (Industry Expert) 1 H
⦁ Pharmaceutical Documents
Brief introduction on standard operating procedure, drug master file, batch manufacturing record, new drug application, investigational new drug application and abbreviated new drug application; differences between calibration and validation; concept of qualification of instruments; certificate of analysis.
Unit – VIII (Academic Expert) 1 H
⦁ Analytical Instruments
Ultra-visible (UV) spectroscopy: Introduction, principle, instrumentation and applications
Infrared (IR) spectroscopy: Introduction, principle, instrumentation and applications
High performance liquid chromatography (HPLC): Introduction, principle, instrumentation and applications
Unit – IX (Industry Expert) 1 H
⦁ Quality management System
Quality assurance (QA): Introduction, finished product releases, quality audit, functions of QA
Quality control (QC): Introduction and functions of QC
Quality management system: ICH-Q10
Unit – X (Industry Expert) 1 H
⦁ Interview tips: Basic questions asked during interview and their appropriate answers.
Evaluation: 2 Hrs
