Annex 5 – Manufacture of Immunological Veterinary Medicinal Products
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PIC/S Annex 5 – Manufacture of Immunological Veterinary Medicinal Products (online GMP regulatory compliance education for personnel who work with immunological Veterinary Medicines).
PIC/S Annex 5 – Manufacture of Immunological Veterinary Medicinal Products
This training course for PIC/S Annex 5 compliance covers the special requirements for the manufacture of vaccines, immunosera, allergens or diagnostic substances for veterinary use.
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 GMP training module for immunological veterinary medicines production 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
PIC/S Annex 5 – Course Scope
PIC/S Annex 5: Immunological Veterinary Medicines
The scope of this Online GMP training course on EU GMP Annex 5 relates to the manufacture of immunological veterinary medicinal products. The veterinary medicines manufacturing GMP 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 roles and functions of Quality Risk Management and GMP training are critical.
The GMP aspects are outlined in this online training course and cannot be over-emphasised.
GMP Education: PIC/S Annex 5: Manufacture of Immunological Veterinary Medicines
Who should complete this course?
- This course is based on PIC/S Annex 5, a globally accepted GMP standard for immunological veterinary medicines
- The course is suitable for a worldwide audience
- PIC/S GMP guidance for veterinary medicines is referred to by most Regulatory Authorities in relation to pharmaceutical manufacturing/veterinary medicines/products manufacturing
- This regulatory compliance course is suitable for all levels of personnel
- GMP compliance training is also applicable/required for suppliers, contractors, and Authorised Representatives who are also expected to understand & comply with PIC/S Annex 5 good manufacturing practice (GMP) requirements for Immunological Veterinary Medicines.
This self-paced, fully-online GMP education course is recommended for:
- Quality personnel in veterinary medicine manufacturing or administration settings (veterinarians, rural veterinarians, agricultural veterinary assistants, veterinary medicine students, new graduates, vet hospitals, veterinarian universities, etc.)
- Operations Personnel (production workers)
- Contractors including manufacturing equipment maintenance vendors
- Suppliers of APIs and other products for immunological veterinarian medicines
- Anyone involved in raw material sourcing, production, storage, and distribution of vet medicines (including administration)
GMP certificate for this PIC/S Annex 5 course
Online GMP courses offer a GMP course Certificate of Completion.
After successful completion of each online course, learners will have the option of printing or saving a personalised GMP Training certificate that meets regulatory PIC/S and EU GMP requirements.
Page last updated: October 19, 2022.