GMP Basics

Introduction

Good Manufacturing Practice or GMP defines the operating principles for the pharmaceutical and biotechnology industries. It is one of the few regulatory concept, that has world-wide acceptance. GMP has helped to standardize the quality of healthcare and improved the quality of our lives. Suppliers, in addition to manufacturers, also adhere to the rigorous principles of the regulations. In fact, GMP has expanded its concept to cover allied operations, such as toxicological laboratories, which is regulated by GLP (Good Laboratory Practice) and clinical studies, which is covered by GCP (Good Clinical Practice). GMP, GLP, and GCP - generically referred to as GxP - are dynamic and under continuous evolution.

Course Description

GMP Basics includes the most recent amendments to the regulations, such as 21 CFR Part 11, and offers the most recent interpretations of the regulators. We have organized the themes around the traditional and not so traditional requirements, such as Standard Operating Procedures, Competency Training, and Design Qualifications. Some of the complex concepts are included only at the awareness level and to provide natural entries to our GMP Intermediate or GMP Advanced competency courses. We have added actual case studies to enhance the value to the trainees and to bring real life experience to learning, and to ensure meaningful competencies even at the basics level.

GMP Basics is multimedia enhanced, and includes competency testing, qualification examination, parameters for interactive training, scheduling, evaluation, and competency validation functions.

CACTUS Integration

GMP Basics is member of the CACTUS Lyceum on-line library of courses and curriculums. GMP Basics, as all of the members of CACTUS Lyceum, is integrated to the following CACTUS sub-systems:

• TIMS (Training Information Management System) with 21 CFR Part 11 compliant module
• METAN (Metrics & Analysis) with 21 CFR Part 11 compliant module

Course Content

• Introduction
• The Regulatory Nature of GMP
• Good GMP-Business Practices
• Good GMP-Personal Practices
• Quality Control & Quality Assurance
• DQ-IQ-OQ-PQ & Validation
• Standard Operating Procedures
• Change Control & Configuration Management
• Competencies & Training
• Documentation & Record Keeping (21 CFR Part 11)
• Facilities
• Equipment
• Processing
• Labeling
• Warehousing
• Maintenance
• Waste-Rejects-Disposals
• Recalls-Resolution & Disposal
• Understanding audits

Learning Objectives

After successful completion of the course-examination, the trainees will understand:

• The compliance meaning of the GMP
• The practical meaning of the GMP
• The responsibilities and duties at the personal level
• The responsibilities and duties at the teams level
• The responsibilities and duties at the business.

Audience

This course is intended for all levels of personnel, who is covered by the GMP requirements.

Web Links to Consultants, Compliance and Audit Officers

OPULUS.COM offers extended capabilities for regulatory audit specialists. We provide extensive on-line Web-database with integrated search capabilities to be able to assist you or your clients even during the most difficult circumstances. You may use these competency resources to prepare yourself or your customers for an upcoming audit, or in case of emergency, such as during on-going audit, to implement sound regulatory advises and solutions. OPULUS.COM is your perfect partner in strategic decision making and in real-time operations.