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Lea Joos
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Lea Joos

Apothekerin.

Published articles

GDP inspections: How to avoid defects

GDP inspections: How to avoid defects

An Interview with Lea Joos, GMP inspector and author of the GMP Compliance Adviser Chapter 16.S.2 "GDP inspections: frequent deficiencies in the qualification of logistics service providers and how to avoid them"

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Inadequate handling of deviations: the cause "human error"

Inadequate handling of deviations: the cause "human error"

In the case of the deviation inspected, it was found that the batch number, which had to be manually transferred to the product before production started, was not correctly transferred to the product. The cause was found to be a "human error" in the manual transfer of the batch number during the root cause analysis.

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Insufficient cleaning validation

Insufficient cleaning validation

During the cleaning validation, the PDE values of the active ingredients were determined in order to implement the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities.

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Frequent Deficiencies in GMP Inspections – Here: Insufficient Maintenance of Rooms

Frequent Deficiencies in GMP Inspections – Here: Insufficient Maintenance of Rooms

During a tour of the production area, it was discovered at several points that the rooms were not sufficiently maintained:

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Reaching the next GMP Level with Inspection Readiness Projects

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