During process validation, you analyse product data – collected during the design and manufacturing process – to confirm that your process reliably delivers products of a certain standard. This applies for various processes, including cleaning, packaging, filling and formulation processes.
The purpose is to ensure that varied inputs lead to a consistent and high-quality output or product, complying with the process validation guidelines from authorities like the Food & Drug Administration (FDA) and the European Medicine Agency (EMA). End-to-end validation of processes is crucial to determine product quality, because inspection of finished products cannot always determine quality.
Process validation is an ongoing process and you must frequently adapt the process to manufacturing feedback. Fortunately, our validation experts are pleased to set up, improve and support the validation of your processes. Thanks to a risk-based validation approach, they help you develop and implement a strategy to optimise product quality and minimise compliancy costs.
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