News

Are Placebo Batches Allowed in Cleaning Validation?

In our News dated 16 August 2023, we referred to a Warning Letter issued to an Indian API manufacturer. Among other things, the FDA criticized the company for residues on internal surfaces of equipment parts. The deviations were found during an FDA inspection conducted in November 2022. In late January/early February 2023, the FDA was back at another site of this company for inspection. What did the FDA find this time?

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Even Non-Reactive Residues Are Considered Cross-Contamination and Require Validation

In a recent Warning Letter, the FDA presented its view on the topic of cleaning validation. What is it about?

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Consequences of manufacturing non-pharmaceutical Products on pharmaceutical Equipment

In October 2022 you could already find out in a news that the FDA does not accept the manufacture of medicinal products on equipment that is also used to manufacture non-pharmaceutical products. But what are the consequences if the FDA does discover such manufacturing?

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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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