Annex 5 – Manufacture of Immunological Veterinary Medicinal Products

Description

PIC/S Annex 5 – Manufacture of Immunological Veterinary Medicinal Products – Training Course

This course is based on PIC/S Annex 5, a globally accepted good manufacturing practice (GMP) standard for immunological veterinary medicines. PIC/S = Pharmaceutical Inspection Cooperation Scheme.

• This module is suitable for all manufacturing and quality personnel involved in the manufacture of vaccines, immunosera, allergens, or diagnostic substances for veterinary use.

About this PIC/S Annex 5 GMP eLearning Course

• This GMP eLearning course covers PIC/S Annex 5 GMP compliance requirements related to the manufacture of immunological veterinary medicines.
• It overviews the special requirements for the manufacture of vaccines, immunosera, allergens, and/or diagnostic substances for veterinary use.

Online GMP regulatory compliance education for personnel who work with Immunological Veterinary Medicines.

Course Agenda & Objectives:

• 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 for Manufacture of Immunological Veterinary Medicinal Products (GMP eLearning for Regulatory Compliance)

GMP Education

This interactive eLearning course (GMP training for PIC/S Annex 5) covers the GMP regulations relating to the manufacture of immunological veterinary medicinal products.  It also discusses environmental concerns and the importance of GMP controls related to these types of medicines, e.g.:

• The importance of ensuring appropriate environmental protections when the manufacture of veterinary medicines involves the use of pathogenic or exotic biological agents
• The importance of adhering to GMP hygiene rules and PPE requirements for personnel (e.g., personnel must be particularly well protected when the manufacture of these medicines involves the use of biological agents pathogenic to humans)

GMP Education: PIC/S Annex 5: Manufacture of Immunological Veterinary Medicines

Who should complete this PIC/S Annex 5 training course?

This GMP eLearning course is suitable for:

• A worldwide audience
• Personnel and contractors working in a variety of roles and capacities in the ‘vet medicines’ manufacturing or distribution sector

This self-paced, fully-online GMP eLearning course for PIC/S Annex 5 is recommended for:

• Quality personnel in veterinary medicine manufacturing or administration settings
  • Veterinarians, rural veterinarians, agricultural veterinary assistants
  • Veterinary medicine students and new graduates
  • Veterinarian hospital personnel, veterinarian medicine 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)

Importance of Regulatory Compliance

Manufacture of Immunological Veterinary Medicine Products: GMP Responsibilities in PIC/S Annex 5

• There is inherent variability related to the manufacture of immunological products.
• 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 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