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ICH Information Material on the ICH Q9 revision Quality Risk Management

Since 2005, the ICH Q9 Guideline on Quality Risk Management has represented the state of the art. A revision was announced at the end of 2020. In January, this revision has reached stage 4 and is now moving into implementation.

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Tasks of Quality Control Unit during Validations - FDA Perspective

In addition to guidelines, interpretations of the FDA's CGMP rules can often be found in Warning Letters. A current Warning Letter describes the FDA's expectations of the Quality Control Unit for validations, among other things.

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What Errors can occur with Swab Sampling during Cleaning Validation?

Two sampling techniques are generally used in cleaning validation. The rinse test and the swab test. The following are notes on potential issues with the swab test.

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Statistical Sampling: an Underestimated Element of Process Validation?

In a recent FDA Warning Letter, the FDA criticizes inadequate process validation for a semi-solid dosage form. What exactly did the FDA find inadequate?

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The new ICH Q9 Revision on Quality Risk Management becomes Effective as of 23 July 2023: A Detailed Analysis

In January you could read about the publication of the revised ICH Q9 guideline. What is new with regard to quality risk management (QRM)?

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ICH Q9 Quality Risk Management published as Revision 1

In December 2020, you could already read about the ICH announcement to revise the ICH Q9 Quality Risk Management Guidelines. The final version has now been published.

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Cleaning in 6th Place in the FDA Warning Letter Statistics

The ECA regularly provides evaluations of the FDA Warning Letters per fiscal year. In 6th place in the fiscal year 2022 (Oct. 2021 - Sept. 2022) are deficiencies regarding the topic of cleaning/cleaning validation. What was found?

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How to react to Deficiencies after an FDA Inspection?

GMP deficiencies are often identified during FDA inspections. Responding to an FDA deficiency report is important, otherwise a Warning Letter may be issued. But how should one respond?

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Manufacturing medicinal and non-pharmaceutical Products on the same Equipment - is that possible?

Is it possible to manufacture medicinal and non-pharmaceutical products on the same equipment? The FDA objects to this manufacturing practice.

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FDA Requirements for the "Worst Case" Product during Cleaning Validation

Bracketing approaches are certainly allowed in the context of cleaning validation. First, for the products themselves, so that a "worst case" substance can be used for validation, second, for devices of the same design, the effort can be reduced by bracketing. In this way, a device can be selected. So how to define these "worst cases"? Read more here about FDA's view on this.

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