Description

Annex 02 – Manufacture of Biological Medicinal Products for Human Use

The objectives of this training module are to understand:

• the different methods by which biological medicinal products may be manufactured and the differing levels and types of regulatory controls
• the principles of biological manufacturing
• the personnel requirements
• the requirements?for premises and equipment
• the requirements for animal quarters and care
• the importance of documentation
• production requirements and the importance of Quality Control

Certification

After successful completion of each course in the bundle the trainee will have the option of printing or saving a personalised training certificate that meets regulatory GMP requirements.