Process Validation Services
How Can We Help?
We work with your team to determine what processes need to be validated. Then, we write the validation plans, protocols and reports. This includes the software, equipment, materials and facilities that make up the process.
We also offer off-the-shelf validation documentation that is ready to be customized by your team.
Our Process
Step
1
Define
The first step is to define the process. Flowcharts are a great tool for this and the actual task of making the flowchart provides a lot of value. You will be surprised how much you learn from the session.
Step
2
Evaluate
The next step is evaluation of the process; we need to decide what steps require validation. We will think through the equipment used, the activities that are performed at each step, facility requirements, and the material inputs and outputs to make this decision.
Step
3
Plan
The next step is to define the validation plan for each item on the flow chart that is identified as needing validation. The output of this phase is the Master Validation Plan and specific validation protocols. This step may include planning equipment IQ/OQ/PQs.
Step
4
Validate
Now, we are ready actually validate the process. This can take anywhere from a few days to a few months depending on the scope of the validation. We use a risk-based approach and leverage as much existing data as possible to streamline this step.
Step
5
Report
The final step in the initial validation is to collate the data and write the validation report. Once the report is signed, then the initial validation is complete. You can now officially say you have a validated process.
Step
6
Revalidate
Over time, you should continue to monitor the process, determine if/when changes should trigger revalidation and when improvements are needed. Routine monitoring is defined in the Master Validation Plan and ad hoc revalidations can be documented in a variety of ways.
What is Process Validation?
Process validation ensures that a process can reliably produce a product. Regulatory authorities like the FDA have rules and guidelines concerning process validation. The goal is to ensure that varied inputs result in consistent and high-quality outputs. It’s an ongoing process that needs frequent adaptation based on manufacturing feedback. End-to-end validation of production processes is crucial for product quality. The FDA discourages relying solely on finished-product inspection, emphasizing that quality should be built into products and processes throughout production, starting at the earliest stage rather than at the end.
When Does a Process Require Validation?
In 21 CFR 820.75 the FDA states where “the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.” This rule makes it clear that not all processes must be validated. The medical device maker is responsible for determining what processes to validate and what processes will rely on inspection data to assure quality. When the manufacturer has determined that validation is not required, that rationale should be documented.
Qualomics can help you with every step of the validation journey from concept to completion.