Industrial Pharmacy II (Theory)
Keywords:
Industrial Pharmacy, Piol Plant, Personnel Requirements, Space Requirements, Raw Materials, Solids, Liquid Orals, Semi Solids, Relevant Documentation, Technology Transfer, Terminology, Technology Transfer Protocol, Quality Risk Management, Risk Analysis, Risk Identification, Premises, Equipment, Qualification, Validation, Quality Control, Regulatory Affairs, Drug Approval, Pharmacology, Drug Metabolism, Toxicology, Quality Management Systems, Total Quality Management, Six Sigma Concept, ISO 14000, Regulatory Requirements, Drug Regulation, State Drugs Control Origination, New Drug ApplicationSynopsis
Industrial Pharmacy is a subfield of pharmaceutical science and technology that focuses on large-scale drug development, production, distribution, and quality assurance. or the transformation of unprocessed materials into specific dosage forms. The goal of Industrial Pharmacy is to provide, in one book, a comprehensive overview of the many pharmaceutical equipment and processes that are regularly used in the manufacturing of pharmaceutical dosage forms, as well as quality control tests of those dosage forms. Comprehending intricate pharmaceutical concepts and manufacturing procedures for pharmaceutical dosage forms is made simpler with the aid of pictorial/graphical illustrations. Considering that it is essential for pharmacy students to grasp the fundamental ideas involved in developing medications into appropriate and reliable dosage forms.
Scope: This Course is designed to impart fundamental knowledge on pharmaceutical product development and translation from laboratory to market.
Objectives: Upon Completion of the course, the student shall be able to:
1. Know the process of pilot plant and scale up of pharmaceutical dosage forms.
2. Understand the process of technology transfer from lab scale to commercial batch.
3. Know different Laws and Acts that regulate pharmaceutical industry
4. Understand the approval process and regulatory requirements for drug products
