This course is based on the FDA, HEalth Canada, and European guidelines (Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively) on GMP and is a complete training solution for all individuals that need to acquire Good Manufacturing Practice knowledge for medicinal products for human use.

Learning objectives

Upon completion of this online course trainees will:

  • be able to understand the basics of Good Manufacturing Practice for medicinal products for human use and the current legal regulations and guidelines;
  • have the confidence to outline the main GMP requirements related to premises, storage facilities and personnel;
  • get familiar with the principles of the GMP quality system and quality control and the important procedures when dealing with complaints and recalls

Course content:

  • What is Good Manufacturing Practice?
  • Why is GMP important?
  • Official GMP Directives.
  • the basic requirements of Good Manufacturing Practice.
  • Principle and overview of the Pharmaceutical Quality System.
  • Development, content and implementation of PQS.
  • Key personnel.
  • Background and duties of the Qualified person.
  • Duties of the Head of production department.
  • Duties of the Head of quality control.
  • Person releasing the batch.
  • Consultants.
  • Personnel training and hygiene.
  • Production area.
  • Storage area.
  • Quality control areas.
  • Ancillary areas.
  • Equipment.
  • Premises.
  • Generation and control of documentation.
  • Types of documents and specifications.
  • Manufacturing formula and processing instructions.
  • Packaging instructions.
  • Procedures and records.
  • General principles.
  • Prevention of cross-contamination in production.
  • Guidelines for starting materials.
  • Processing operations.
  • Packaging materials and operations.
  • Guidelines for finished products.
  • General principles.
  • Main tasks of the Quality control department.
  • Technical transfer of testing methods.
  • Transfer protocol.
  • GMP Guidelines related to complaints.
  • Classification of defects.
  • Product Recalls.