Good Manufacturing Practice (1 hr Lecture + 1 hr Practical)

Description

This course allows students to understand the basic concept of GMP, the interrelations between GMP and related systems and the impact of GMP in the design and operation of a pharmaceutical factory. By the end of this course, the student should be able to describe the basic idea behind GMP, its definition, purpose and the relation of GMP to other systems such as quality management and ISO; label personnel GMP requirements such as qualifications, experience, and training with special emphasis on key positions; tell about materials handling, requirements and uses, sampling methods, when and how to use each; identify equipment GMP requirements and describe types of water used in pharmaceutical industry as well as different methods to purify water from contaminants and important aspects in the design of high purity water systems.

Program

Bachelor of Pharmacy - PharmD (Clinical Pharmacy)

Objectives

• 1.1	Recognize the golden rules of good manufacturing practice.
  1.2	Identify the role of GMP in the lifecycle of pharmaceutical products, from development to distribution, the theory of product recall, and the role of risk management.
  1.3	Describe the importance of Statistical process control, validation, facilities, equipment maintenance & environmental monitoring in maintaining GMP compliance.
  1.4	Illustrate the steps for material handling and sampling methods, laboratory control, and SOP writing.
  2.1	Recognize the ethical implications of GMP in ensuring the safety, quality, and efficacy of pharmaceutical products, in addition to the strategy of product recall.
  2.2	Assess the personnel's professional responsibilities of adhering to GMP regulations and the consequences of non-compliance.
  2.3	Comply with procedures to manage risk and improve safety in the manufacturing processes.
  4.1	Implement problem-solving skills related to manufacturing processes.
  4.2	Use contemporary technologies and media to demonstrate effective presentation skills.
  4.3	Promote lifelong learning and staying updated with advancements and changes in GMP standards and practices.