Annex 05 – Manufacture of Immunological Veterinary Medicinal Products
This interactive elearning / online GMP training Annex 5 module covers the GMP regulations relating to the manufacture of immunological veterinary medicinal products. This module is suitable for all manufacturing and quality personnel involved in the manufacture of vaccines, immunosera, allergens or diagnostic substances for veterinary use.
The objectives of this training module are:
- to understand operating principles related to containment
- to understand the principles that underpin filling techniques
- to understand the importance of equipment and environmental considerations
- to understand the requirements for disinfection and waste disposal
- to understand the importance of validating production methods
- to understand Quality Control requirements
The scope of this Online GMP training course on EU GMP Annex?5 relates to the manufacture of immunological veterinary medicinal products. The course covers aspects of the environment especially ensuring protection when the manufacture involves the use of pathogenic or exotic biological agents and the worker must be particularly well protected when the manufacture involves the use of biological agents pathogenic to man.
These factors, together with the inherent variability of immunological products and the relative inefficiency in particular of final product quality control tests in providing adequate information about products, means that the role QA and GMP training?are?critical.
The GMP aspects are outlined in this online training course and cannot be overemphasised.
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 PIC/S and EU GMP requirements.