Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.
At Nelipak quality, safety and efficacy are designed or built into each product. Each step of our manufacturing process is controlled to assure that the product meets all specifications. During manufacturing, product quality, in the context of process validation means that product performance is consistent from batch-to-batch and unit-to-unit.
Using customer driven templates or Nelipak custom designed versions, our quality engineering team provide everything from the validation plan to the final reports using industry standard methods conducted to ISO 9001, ISO 13485 standards and 11607 part II guidelines.
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