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Cleaning Validation: What can a Quality Risk Management Approach Look Like?

With the implementation of the ICH Q9 document, risk management has become mandatory in virtually all GMP areas. This also applies to cleaning validation. But what can such a quality risk management approach look like for cleaning validation? The American Society of Testing and Material (ASTM) has recently issued a guideline on a Science-Based and Risk-Based Cleaning Processes Development and Validation. What does the Guide suggest?

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Cross Contamination: One of FDA's Current Issues

In a current Warning Letter from November 2018, the FDA criticised insufficient cleaning validation and verification at a pharmaceutical manufacturer. They referred to 21 CFR 211.67 (a). What was the reason for this?

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Warning Letter for Korean Manufacturer due to Poor Sterile Practices

As a result of repeated deviations in the area of aseptic manufacturing, a Korean manufacturer has received a Warning Letter from the FDA.

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British Regulatory Authority MHRA criticises Cross Contamination Issue

The publication of EMA's "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities" and the related Q&A documents have given the topic cross contamination a greater importance.

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British Authority MHRA provides Interpretation on Cleaning Validation

With the introduction of the Permitted Daily Exposure (PDE) values in conjunction with questions on cross contamination and on cleaning validation, the EMA began a new chapter a few years ago. This is a complex issue and it caused uncertainty within the industry. Insofar, the EMA brought a subsequent Q&A document. This is being interpreted by the British Regulatory Authority MHRA with regard to inspection results.

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Qualification of Identical Pieces of Equipment: is a Bracketing Approach acceptable?

Again and again, the question arises as to whether a bracketing approach - i.e. selective skipping of individuals tests - may be used for the qualification of identical pieces of equipment. Can the answer to the question whether or not to skip individual tests be found in Part IV of the EU GMP Guide?

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Current Questions on Validation of Blend Uniformity - Stratified Sampling

Validating blend uniformity is a decisive factor for the validation of solid dosage forms. In Europe, there are no regulatory provisions for this. This is different in the USA: the 21 Code of Federal Regulation (CFR) 211.110 requires the regular assessment of the adequacy of mixing.

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New Top Lecture available - FDA´s Thinking about Modern Qualification and Validation

What is the FDA´s current thinking with regard to Modern Qualification and Validation? You will find out in a recent lecture from FDA Director Grace McNally.

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How did the EMA Q&A Document on the use of PDE Values come about?

In June you could already read about the Q&As of the European Medicines Agency (EMA) on the use of PDE (HBEL) values in connection with cross contaminations and cleaning validation. The EMA has now published a report which describes how these questions and answers came into being.

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What are FDA's Expectations from Contract Manufacturers?

In a four-page Warning Letter to a contract manufacturer who produces semi-solid OTC products, the FDA criticizes amongst others the missing tests of starting and finished products.

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