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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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Are you familiar with the Verification Guide ASTM E 2500?- ECA Modern Qualification Survey Results

Last week part I of ECA´s survey about "Modern Qualification" was published. In the following you will find further results of ECA's survey on modern qualification.

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FAT & SAT not frequently used as Part of Qualification - ECA Modern Qualification Survey Results

The ECA set up a survey to find out to what extent qualification and validation programmes are integrated as actually made possible by the EU Annex 15 and the FDA Process Validation guide – and to what extent suppliers are involved. Read more about the Qualification/Validation Survey results.

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FDA criticises missing stage 3 in validation lifecycle

In a five-page warning letter to an OTC manufacturer, the US Food and Drug Administration (FDA) criticises, inter alia, the missing program for continued  process verification.

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No second chance for a first impression - inspection result by a European supervisory agency

The Maltese competent authority has performed an initial inspection at the facility of an Indian manufacturer and packer in March 2018. This resulted in a Non-Compliance Statement regarding GMP.

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