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Bioprocess Engineering 2nd Edition by Fikret Kargi,Michael Shuler
Edition 2ISBN: 9780130819086Bioprocess Engineering 2nd Edition by Fikret Kargi,Michael Shuler
Edition 2ISBN: 9780130819086 Exercise 2
When the FDA approves a process, it requires validation of the process. Explain what valida-
tion means in the FDA context.
tion means in the FDA context.
Explanation
Verified
Verified
When the Food and Drug administration (FDA) approves a process, it requires validation of the process. In the FDA context, validation means establishing documented evidences for procedures. The documented evidence for a specific process would provide a high degree of assurance that it will produce a product with consistency. This will help in maintaining the quality of products and its specifications that are predetermined.
The FDA also stresses the need for written procedures for the product production and the process-control. This will assure the identity, strength, quality, and purity of the product. Not only the equipment and procedures used in the production must be validated, but also computer softwares used to monitor the process should be validated.
The FDA also stresses the need for written procedures for the product production and the process-control. This will assure the identity, strength, quality, and purity of the product. Not only the equipment and procedures used in the production must be validated, but also computer softwares used to monitor the process should be validated.
Bioprocess Engineering 2nd Edition by Fikret Kargi,Michael Shuler
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