Introduction to GMP and Quality Systems

Course description

GMP is short for Good Manufacturing Practice and is commonly used also for Quality Management systems related to manufacture of medicinal products/pharmaceuticals. Other organisations within the Life Science industry, e.g. developers of IVDs and Medical Devices have to follow similar requirements. In this introductory course, you will get an overview of the requirements and guidelines that governs quality management related to manufacturing. The course is based on requirements for pharmaceuticals but regulatory requirements and ISO 13485 for medical device quality systems is briefly covered.

Course outline

• Background and history of GMP and quality systems
  • Review of the patient perspective and how requirements have evolved over time and continue to improve
• Role of authorities and their inspection
  • Different authorities and how oversight and inspections are handled
• Overview of different regulatory requirements
  • Short introduction to the different requirements  that influence quality systems for manufacturers of medicinal products, active pharmaceutical ingredients and companies developing medical devices in EU and USA
• GMP Compliance
  • An overview of important parts of the requirements with focus on the objectives – i.e. the quality risks that needs to be minimised. Focus is on manufacturing operations
• Introduction to validation and qualification
  • Short walk-through of concept and terminology for qualification of manufacturing equipment and validation of manufacturing processes.
• Documentation requirements
  • Purpose of Standard Operating Procedures and instructions and how they may be designed
  • Basic requirements on records – how to record data correctly
  • Data integrity

Learning objectives

• Understand and define different terms used and being able to navigate in applicable regulatory texts and guidance from authorities
• Get additional knowledge in the specific GMP requirements related to manufacture of pharmaceuticals and medical devices/IVDs
• Be familiar with the most common terms and the general methodology for qualification and validation
• Be familiar with the basic requirements related to instructions and records, regardless of if they are in paper or electronic form to ensure data integrity

Who should attend

• Newly employed or persons that shall start to work in regulated Life Science industry, such as:
  • Employees within quality, production development, QC and laboratory operations
  • Support functions, purchasing/logistics, tehcnical and maintenance
  • Consultants, contractors, and suppliers to this industry

Prerequisites

No pre-requisites

Is the Introduction course the right level for someone with some GMP/QS experience?
To get the most out of your training, we want to make sure that the course you are planning to take is at the “right” level.
On an introductory course like this, this is important both for yourself and for the others at the course.
If you already have basic knowledge and experience in the field, an advanced course may be more appropriate.

#5113en