How do you manage third-party involvement in GMP production?

1 Define your requirements

Before engaging with any third-party partner, you need to clearly define your requirements and expectations for the GMP production process. This includes the scope, deliverables, specifications, quality standards, documentation, training, validation, audits, and communication methods. You should also establish the roles and responsibilities of each party, as well as the escalation procedures and corrective actions in case of non-compliance or deviation. You should document these requirements in a written agreement or contract that outlines the terms and conditions of the partnership.

2 Evaluate and select your partners

Once you have defined your requirements, you need to evaluate and select your third-party partners based on their qualifications, capabilities, experience, and reputation. You should conduct a thorough due diligence process that includes checking their references, certifications, accreditations, and previous projects. You should also verify their compliance with the applicable GMP regulations and guidelines, as well as their quality management system and procedures. You should perform a risk assessment to identify and mitigate any potential hazards or issues that may affect the GMP production process.

3 Monitor and review their performance

After selecting your third-party partners, you need to monitor and review their performance throughout the GMP production process. You should establish regular communication and feedback mechanisms to ensure that the project is progressing as planned and that any issues or concerns are addressed promptly. You should also conduct periodic audits and inspections to verify that the third-party partners are following the agreed GMP standards and practices, and that they are documenting and reporting any deviations or non-conformities. You should review and approve any changes or modifications that may affect the GMP production process or the quality of the product.

4 Manage any deviations or non-conformities

Despite your best efforts, you may encounter some deviations or non-conformities during the GMP production process that involve your third-party partners. You should have a robust system for managing these situations, including identifying the root cause, implementing corrective and preventive actions, documenting and reporting the incident, and evaluating the impact on the product quality and safety. You should also communicate and collaborate with your third-party partners to resolve the issue and prevent recurrence. You should follow the agreed escalation procedures and contract terms in case of any disputes or liabilities.

5 Maintain a continuous improvement culture

Finally, you should maintain a continuous improvement culture with your third-party partners to ensure that the GMP production process is always optimized and enhanced. You should solicit and provide feedback and suggestions for improvement, as well as share best practices and lessons learned. You should also recognize and reward good performance and compliance, as well as identify and address any gaps or weaknesses. You should foster a strong relationship and trust with your third-party partners, based on mutual respect, transparency, and collaboration.

6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?