Learning Objectives

Employees must be directly involved in assuring compliance with current Good Manufacturing Practice (cGMP) guidelines within their organization in all efforts aimed at generating regulated data.  All participants will gain a fundamental understanding of the basis of the regulations, the necessity of rigorously implementing them in their groups monitoring compliance in their and the collaborator’s organizations and incorporating this regimen and pro-active thinking in all scientific matters.  Consequences of non-compliance will be examined.

Course Description

Good Manufacturing Practice regulations (cGMPs) are used by pharmaceutical, medical device and food manufacturers as they produce and test products that people use (Drug cGMPs also apply to the veterinary drugs).  In the United States (U.S.) the Food and Drug Administration (FDA) has issued these regulations as the minimum requirements.  This course explores the regulations through which the Federal government controls the drug, cosmetics and diagnostic industries.  Major emphasis is placed on understanding the need for and the intent of regulations and developing mechanisms for implementation and compliance.

This course is intended to give participants an introduction to cGMP regulations and their application to laboratory studies and manufacturing processes.  It will also provide participants with an understanding of terminology and the role GMPs play in assuring their validity.  Those attending will also get an understanding of the needs for thorough and comprehensive training and documentation.

Additionally, this course introduces students to the principles of GLP/GMP in the pharmaceutical and associated industries with the emphasis on the necessary procedures and documentation required to achieve full compliance.  Upon completion of this course, students will have an understanding of the various aspects of GMP regulations including:

• Attributes of materials, including formulation components, container and closure systems, labels and labeling, materials in process, and finished pharmaceuticals
• Methodology, including documentation, manufacturing validation, quality assurance, quality control, and supportive manufacturing operations 
• Personnel and facilities, including building, equipment, instruments and infrastructure 
• Analytical and laboratory validation and compliance programs
• The process of an FDA inspection and the compliance auditing process
• "The Concept of Compliance" - understanding the why behind the GMP regulations