The European pharmaceutical industry is entering a new compliance phase with separate GMP requirements for human and veterinary medicinal products. Organisations manufacturing both product types must understand how these regulatory changes affect their quality systems. The human vs veterinary GMP split means companies will have to review documentation, manufacturing and operations to remain compliant. Early compliance will help reduce regulatory risk with minimal impact on production for both portfolios.
The Historic Split
One of the biggest regulatory changes is the formal separation of veterinary GMP requirements from EudraLex Volume 4 into dedicated legislation. EU veterinary GMP regulation also sets out what is expected of compliance in terms of veterinary medicinal products as opposed to that which is set in the human medicines. This variance enables regulators to take into account the specific manufacturing risks and quality concerns that apply to the veterinary sector. Consequently, what is expected from the regulatory teams needs to be understood and updated in terms of the regulatory framework.
Documentation Remapping
Regulatory changes require organisations to review and update quality documentation across all departments. Existing operating procedures, quality manuals, validation records, training and process validation documentation, and risk assessments should be mapped to current regulations. With Commission Implementing Regulation 2025/2091 arriving, companies should identify where regulations refer to older regulations, update controlled documents, and ensure staff are following the new regulations. Reduced compliance gaps through a formal document review and update prepare facilities for future regulatory inspections.
Sterile Manufacturing Separation
Those involved in the production of sterile products should ensure that manufacturing processes consider the individual requirements of human and veterinary medicines. In relation to shared equipment, environmental monitoring, contamination control and cleaning validation, procedures should be assessed and adapted where necessary to enable them to be applied without compromising the quality of either product. Where necessary, separate procedures or additional controls should be implemented to prevent cross-contamination and ensure compliance.
Dual-Site Operations Strategy
Organisations operating both human and veterinary manufacturing facilities should develop a clear dual portfolio PQS that supports both regulatory frameworks while maintaining operational efficiency.
Key priorities include:
- Differentiate quality documentation that holds different regulatory compliance.
- GMP training should be given to your staff according to their specific roles.
- Conduct risk based analyses for common areas and equipment.
- Regularly review quality systems against current regulations.
Implementation of a process provides structure, enabling quality teams to achieve compliance without unnecessary duplication of effort and to ensure consistent quality across portfolios.
Conclusion
The separation of human and veterinary GMP requirements represents an important regulatory change for pharmaceutical manufacturers. If you have a review system in place for documentation, reinforcing quality systems and defining operational controls, you will be in a better position to pass the next inspections. Being proactive in satisfying compliance will allow your organisation to effectively manage the product portfolio while fulfilling mandatory European standard points.
FAQs
1. Can a shared facility still manufacture both human and veterinary medicinal products on the same line?
Yes, as long as all risk controls, cleaning validation, and all regulations are fully satisfied.
2. Does EU GMP Annex 1 still govern veterinary sterile manufacturing?
The relevant requirements for sterile manufacturing are determined by the present-day veterinary regulations and the type of product.
3. What is the most immediate task for quality teams operating dual-portfolio sites?
Review and revise all quality documentation, procedures, and training material for compliance to new regulations.
