Process validation.
Where this comes from
- Record sourced from PubMed, PMID 20426548.
- Also identified by DOI 10.1080/0032472031000141308.
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Abstract
Process validation is a required element in the clinical good manufacturing practice equation that helps to ensure that systems are performing in the intended manner and that the product we manufacture has the required potency, purity and safety. The parameters defined during the validation process help to define the elements of process control and provide a mechanism for on-going quality assurance, quality control, training, competency review and continuous improvement.
Medical subject headings
- Cell- and Tissue-Based Therapy
- Hematopoietic Stem Cell Transplantation