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The GMP/GDP Inspectors Working Group decided at the end of 2023 to extend the validity of GDP and GMP certificates that expired at the end of the year until 2024 or until the next on-site inspection, whichever occurs first. It has now been clarified that from 2025, this extension no longer applies.

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In February 2025, the U.S. FDA issued a Warning Letter to the Indian company "Tyche Industries Ltd" due to insufficient Documentation Practices.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an American contract testing laboratory, emphasizing that it considers contractors as extensions of the manufacturer’s own facility. The authority identified critical deficiencies, including the failure to validate microbiological testing methods in accordance with USP standards and inadequate investigation of temperature and humidity deviations in laboratory equipment.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter highlighting significant deviations from Current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs). A facility in China was found to have multiple compliance deficiencies based on a review of records submitted in response to an FDA request.

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In January 2025, the U.S. FDA issued a Warning Letter on its webpage due to the lack of evaluation of impurities - also during the stability studies.

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The Swiss Medicines Agency Swissmedic and Health Canada have agreed to expand their approach to implementing the current MRA. More inspections will now be recognised.

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter following an inspection conducted in September 2025. The contract testing laboratory in question analyzed active pharmaceutical ingredients (APIs) and intermediates for compliance with regulatory standards for the U.S. market.

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In January 2025, the Task Force "Data Integrity" of the Quality Group of APIC, a sector group of the European Chemical Industry Council (CEFIC), published version 2 of the document "Data Integrity Frequently Asked Questions (FAQ)" on its website. Updated and new questions and answers can be found in the "Password management" and "Access management" sections.

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The new version of the "CADIFA Manual for Administrative Procedures" of the Brazilian Health Regulatory Agency (Anvisa) was published in February 2025 and is available on its website in Portuguese and in English language.

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After inadequate root cause analyses were repeatedly the subject of FDA Warning Letters, another one was published on this topic. This time for a global company with a site in the USA.

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