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Two FDA Warning Letters issued in April illustrate how quickly FDA confidence erodes when investigations stop at retesting, "probable cause" statements, or training-only fixes, without an evidence-based root cause, appropriate scope expansion, and demonstrable CAPA effectiveness.

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FDA is piloting one-day inspectional assessments to make oversight more targeted and efficient. The initiative introduces shorter, focused screening visits alongside standard inspections.

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The Chinese National Medical Products Administration (NMPA) – through the Centre for Drug Evaluation and Inspection (CDEI) – has released a draft guidance for public comment on the inspection of data integrity in pharmaceutical quality control laboratories. The document highlights inspector expectations for data reliability (ALCOA++) in pharmaceutical quality control laboratories, covering governance, lifecycle data management, risk-based controls, and typical deficiencies in paper, computerized and hybrid environments.

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A Warning Letter issued by the FDA in February once again highlights the inadequate microbiological testing of non-sterile medical devices. In some cases, devices were approved without any testing at all.

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In both, the EU and the US, it is illegal to place a medicinal product on the market without approval. This raises the question: What do you need to know from a GMP perspective about medicinal product authorisations in the EU and the US?

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The use of reference substances is a key component of pharmaceutical analysis and quality assurance. Reference substances (or reference standards) play a crucial role in ensuring the safety, harmlessness and efficacy of medicinal products. Find out more on how reference substances are used in the pharmaceutical industry.

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US FDA has published a Warning Letter highlighting weaknesses that can occur in any GMP process. In this Letter OOS investigations and changes in electronic systems were not adequately addressed in the CAPA system.

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The FDA has issued a new Warning Letter to an OTC drug manufacturer in Palm Bay, Florida. The agency cites significant CGMP deficiencies, with a strong emphasis on laboratory control and analytical oversight, including missing finished-product testing prior to batch release, weaknesses in incoming-material testing and supplier/COA qualification, an inadequate stability program, and inadequate QU oversight.

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Documentation fulfils several key functions within the GMP environment and is an indispensable component of quality assurance. This raises the question: what exactly is meant by the term 'Good Documentation Practice'?

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Despite MRAs, not all types of inspections are recognised in practice; for example, "for-cause" inspections have so far not, or only rarely, been covered. These are also increasingly conducted without prior notice.

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