What are the best practices for aligning equipment qualification with process validation?

1 What is equipment qualification?

Equipment qualification (EQ) is the process of verifying that your equipment is suitable for its intended use, and that it meets the specifications and requirements of your process. EQ typically involves four stages: design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Each stage has its own objectives, tests, and documentation to ensure that your equipment is safe, reliable, and effective.

2 What is process validation?

Process validation (PV) is the process of demonstrating that your process can consistently produce products that meet the predefined quality attributes and specifications. PV usually involves three stages: process design, process qualification, and continued process verification. Each stage has its own activities, data, and controls to ensure that your process is robust, capable, and compliant.

4 How to align EQ and PV?

Aligning EQ and PV is not a one-size-fits-all solution, as different products, processes, and equipment may have distinct requirements and challenges. However, some general best practices can be applied. Firstly, a cross-functional team should be established to coordinate and communicate between engineering, quality, production, and regulatory affairs. Clear and realistic acceptance criteria should then be defined based on quality risk assessment, product knowledge, and regulatory expectations. This should be consistent, measurable, and achievable. After that, EQ and PV activities should be planned and executed in a sequential manner following a predefined protocol. Data should then be collected and analyzed using statistical methods to generate reliable results. Finally, documentation should be reported according to standards and guidelines with evidence and rationale for qualification and validation. This should then be reviewed, approved, and stored securely.

5 What are the benefits of aligning EQ and PV?

Aligning EQ and PV can bring many benefits to your manufacturing process, such as improving product quality, enhancing customer satisfaction, increasing operational efficiency, and strengthening regulatory compliance. Specifically, it can ensure that your equipment and process are fit for purpose and can deliver the desired outcomes, as well as ensure that your products meet or exceed customer expectations and requirements. Additionally, it can reduce downtime, scrap, rework, and recalls, while optimizing resource utilization and cost savings. Finally, it can help demonstrate your commitment to quality and excellence by ensuring that your equipment and process meet the applicable laws, regulations, and standards.

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?