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Review

Qualification and Validation

Renza Monteleone  1 , Dieter Klarmann  2
Mahmoud Aljurf  1 , John A. Snowden  2 , Patrick Hayden  3 , Kim H. Orchard  4 , Eoin McGrath  5
, editors.
In: Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: The JACIE Guide [Internet]. Cham (CH): Springer; 2021. Chapter 5.
.
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Review

Qualification and Validation

Renza Monteleone et al.
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Excerpt

Qualification and validation are integral components of the quality risk management system. Decisions about the scope and extent of qualification and validation should be based on detailed and documented risk assessments performed by the key transplant program personnel (collection/processing/clinical) who are responsible for critical aspects of the relevant operations over the life cycle of the product or process.

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References

    1. EudraLex. Volume 4. EU guidelines for good manufacturing practice for medicinal products for human and veterinary use Annex 15: qualification and validation. http://academy.gmp-compliance.org/guidemgr/files/2015-10_annex15.pdf.
    1. EudraLex. The rules governing medicinal products in the European Union. Volume 4. Good manufacturing practice medicinal products for human and veterinary use Annex 11: computerized systems. http://academy.gmp-compliance.org/guidemgr/files/annex11_01-2011_en.pdf.

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