Process Validation

Master validation plan, Measurement and testing, Process Documentation

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.

Process validation may be conducted at different points during the life cycle of a product.

  • Prospective validation is conducted before a new product is released for distribution or, where the revisions may affect the product’s characteristics.
  • Retrospective validation is the validation of a process based on accumulated historical production data. This data may be found in batch records, production log books, lot records, control charts, test and inspection results.

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 13485 standards and 11607 part II guidelines.

Main features of Process Validation:

  • Master Validation Plan (MVP)
  • Installation Qualification (IQ)
  • Design of Experiment (DOE)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Gage R&R, ATMV, KAPPA study
  • Measurement Analysis
  • Master Validation Protocol / Report

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