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Eudralex Vol 4: New annex 15 – Qualification

Explore the 2015 updates in Eudralex Vol 4: New Annex 15, covering expanded process validation, QbD, and innovative pharmaceutical manufacturing approaches.
Eudralex Vol 4 New annex 15 Qualification (PART 2)

In 2015, a significant update to Eudralex Volume 4: New Annex 15 brought transformative changes to the field of process validation. These amendments not only expanded the scope of validation practices but also introduced innovative approaches that redefine how the pharmaceutical industry ensures product quality and process robustness.

This blog post delves into these critical updates, shedding light on the expanded scope of process validation and the introduction of new methodologies that are essential for maintaining consistent product quality and ensuring robust processes in the dynamic landscape of pharmaceutical manufacturing.

Expanded Scope of Process Validation

The process validation section has recently undergone a notable expansion, increasing from 2 to 4 pages. This extension incorporates additional sections that cover critical aspects such as:

  1. Verification of Transportation: Addressing the complexities of transportation, this section emphasizes the need to define transport routes with consideration for seasonal variables and to monitor critical external factors. For uncontrollable variables, a comprehensive risk assessment is mandatory.

  2. Validation of Packaging: Recognizing the impact of equipment variation on packaging integrity, the guidelines now require qualification for both primary and secondary packaging equipment. This qualification must encompass the minimum and maximum ranges for critical process parameters.

  3. Qualification of Utilities: The quality of utilities like steam, water, air, and gases plays a pivotal role in process validation. The plant must be qualified with consideration for seasonal changes and intended use, especially when direct product contact is possible.

  4. Validation of Test Methods: Ensuring the reliability of test methods is paramount. All methods used in qualification, validation, or cleaning validation must be validated, including a specific focus on microbial testing to ensure no interference from products or cleaning agents.

Innovative Approaches in Process Validation

The new guidelines introduce flexibility and innovation in process validation methodologies. These include:

  1. Continuous Verification Approach: Besides the traditional approach, a continuous verification method is now permissible. This approach focuses on consistent monitoring and adaptation of the process, ensuring ongoing quality assurance.

  2. Hybrid Approach: A novel concept, the hybrid approach combines empirical and historical batch data to develop a comprehensive understanding of the product and process. This approach is particularly useful in case of changes or ongoing process verification, even if the initial validation was traditional.

  3. Quality by Design (QbD): The QbD approach is explicitly recognized and encouraged. It demands a thorough demonstration of process knowledge, especially when using design space justification and mathematical models.

Regulatory Compliance and Lifecycle Management

The new annex emphasizes several key points for maintaining compliance and managing the lifecycle of processes:

  1. Prohibition of Retrospective Validation: Retrospective validation is no longer acceptable, and the relevant section has been removed from the guidelines.

  2. Concurrent Validation: Allowed in exceptional circumstances, concurrent validation requires clear justification and documentation in the validation master plan. The role of the Quality Person (QP) in batch certification during concurrent validation is now explicitly described.

  3. Ongoing Process Verification: Regardless of the validation approach, ongoing process verification is mandatory. This includes constant monitoring and regular adaptation of the verification process itself.

Conclusion

The updated process validation guidelines mark a significant shift towards more flexible, innovative, and comprehensive approaches. By embracing these changes, organizations can ensure robust processes, consistent product quality, and regulatory compliance. As the industry continues to evolve, staying informed and adaptable is key to success in this dynamic environment.

Whether you’re seeking guidance, training, or collaborative opportunities, the QbD Group is your go-to resource for staying ahead in the field. Connect with us today and be part of a community that’s shaping the future of quality in the pharmaceutical industry.

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