PP 106: Pharmaceutical Manufacturing Technology
CIP Code: 41.0303
Duration : 40 Credits (9 Months)
Total Tuition: $ 16.100.00
(Tuition fee: $ 15,100 + Books: $ 200 + Lab: $ 700 + Reg. fee: $ 100
Min. Requirement: High School Diploma / GED
Objectives: This program has been developed to meet the needs of two diverse groups: those in the pharmaceutical industry who need to upgrade their existing skills and/or acquire new skills and knowledge in other areas of the industry, and those contemplating a career change who require relevant knowledge and experience of the pharmaceutical industry. Pharmaceutical Manufacturing Technicians are responsible for implementing the strict and stringent processes and procedures involved in the fabrication of dosage forms of medicines. They implement these procedures with knowledge of pharmaceutical equipment, documentation procedures and Good Manufacturing Practices (GMP).
GEC 101: Introduction to Pharmaceutical Industry (3 Credits)
GEC 102: Good X Practices (3 Credits)
GEC 103: Drug Discovery & Development (3 Credits)
GEC 104: Food & Drug Regulations (3 Credits)
GEC 105: Pharmaceutical Calculations (3 Credits)
PMT 201: CMC Regulations (3 Credits)
PQA 201: Quality Audits (3 Credits)
PVD 201: Method Validation (3 Credits)
PVD 203: Method Validation Lab (1 Credits)
GRA 201: Global Regulatory Affairs (3 Credits)
PMT 202: Pharmaceutical Manufacturing (3 Credits)
PMT 203: Pharmaceutical Manufacturing Lab (1 Credits)
INS 401: Internship (10 Credits)
CPH 401: Course preparation (0 Credits)
Term - 1:
The basic module is designed to provide students an in-depth knowledge of Manufacturing Technology. This course covers state-of-the-art pharmaceutical processing, identifying underlying chemical process engineering principles and providing quantitative approaches to drug product manufacturing process design and optimization.The Basic Foundation module is designed to provide a theoretical introduction to essential pharmaceutical sciences, manufacturing techniques, basic regulatory affairs and current Good Manufacturing Practices (GMP). Trainees also acquire an understanding of the scientific principles of drug manufacturing, as well as the law and ethics that govern the industry.
This course provides an overview of the pharmaceutical industry, including basic information about drug discovery and development, FDA requirements and approval processes, drug dosage forms, and the role of key operational units in drug manufacturing processes. This course enables the students to: understand the role of the pharmaceutical industry in the global market and its implications; learn the fundamentals of the drug development cycle and the investment required to bring a drug to market; learn the most important drug manufacturing processes and the key elements of dosage formulation.
The intermediate module focuses on practical training in pharmaceutical experimental design, formulation technology and manufacturing techniques. Hands-on experience is acquired through team-based projects, in compliance with GMP and GLP, in our state-of-the-art research laboratories and manufacturing plant. Analytical techniques, problem solving, protocol and technical writing skills are acquired throughout the module.
This course is focused on the development of a working knowledge of the Federal Code of Regulations and its impact on the pharmaceutical and allied industries. The history of the Federal Governments regulation of the pharmaceutical industry is studied. Also covered are the industries response and the methodologies it uses to comply with these regulations
Upon completion of this module, trainees are exposed to full GMP compliance in a state-of-the-art pilot plant where they acquire hands-on expertise in granulation and compounding. In addition, this hands-on component fosters teamwork, problem-solving and troubleshooting skills to operate and maintain equipment under minimal supervision.
In this module, trainees gain an in-depth understanding of compression science, as well as the critical aspects involved in tablet making. While integrating GMP compliance, particular emphasis is given to the technical skills required for equipment operation, maintenance and troubleshooting.
COATING / ENCAPSULATION TECHNOLOGY
The advanced module provides an opportunity to engage in independent drug development and research projects. The focus is on drug delivery, dosage form design, process development and scale-up technology.
1. Coating technology trainees acquire an understanding of the scientific principles of coating processes, Micro-encapsulation and the ability to identify and correct coating defects.
2. Upon completion, valuable hands-on experience is gained with different coating systems in our pilot manufacturing plant.
3. Encapsulation Technology module provides in-depth Knowledge
4. Understanding of the various equipment, filling mechanisms, and properties of materials suitable for encapsulation.
Term 3 Internship
Students who are at the final stages of their program and have excelled in all aspects of their training may apply their expertise for an internship. These opportunities allow selected students to gain additional experience through working with staff and faculty on one of the many unique projects undertaken at the Institute.