How do you maintain GMP quality and safety when implementing change?

1 Assess the impact

Before you implement any change, you need to assess its impact on the quality and safety of your products and processes. You need to identify the reasons, objectives, and scope of the change, as well as the potential risks and benefits. You also need to evaluate the regulatory requirements and implications of the change, and consult with the relevant authorities if needed. You should document your impact assessment and use it as a basis for your change control plan.

2 Follow the change control plan

A change control plan is a document that outlines the steps, responsibilities, and timelines for implementing and verifying the change. It should also include the criteria for approval, rejection, or revision of the change, as well as the contingency plans in case of unforeseen issues or deviations. You should follow the change control plan rigorously and ensure that all the stakeholders are informed and involved in the process. You should also document all the actions and decisions related to the change control plan.

3 Validate the change

Validation is a critical step to ensure that the change meets the predefined specifications and does not compromise the quality and safety of your products and processes. Validation involves testing, verifying, and documenting the performance, functionality, and reliability of the change under normal and extreme conditions. You should follow the validation protocols and procedures that are appropriate for the type and scale of the change, and use qualified equipment, methods, and personnel. You should also document the validation results and report any deviations or problems.

4 Train the staff

Training is essential to ensure that the staff are aware of and competent in the new or modified products and processes. Training helps to prevent errors, confusion, and non-compliance that can affect the quality and safety of your products and processes. You should provide adequate and timely training to all the staff who are involved or affected by the change, and use appropriate methods, materials, and tools. You should also document the training activities and evaluate the effectiveness of the training.

5 Monitor the outcomes

Monitoring is an ongoing activity that helps you to measure and evaluate the outcomes of the change. Monitoring helps you to detect and correct any issues, deviations, or adverse effects that may arise from the change, and to ensure that the change meets the expected standards and objectives. You should use suitable indicators, methods, and tools to monitor the quality and safety of your products and processes, and to collect and analyze data. You should also document the monitoring results and report any findings or recommendations.

6 Review the change

Reviewing is a periodic activity that helps you to assess the overall performance and impact of the change. Reviewing helps you to identify and implement any improvements, corrections, or adjustments that may be needed to optimize the quality and safety of your products and processes. You should conduct reviews at regular intervals and after significant events or incidents that may affect the change. You should involve all the relevant stakeholders and use objective evidence and feedback. You should also document the review outcomes and actions.

7 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?