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GMP News

PIC/S publishes a Q&A document to assist with Annex 1

The new PIC/S interpretation document brings together practical answers on the revised Annex 1 - from the CCS and personnel qualification to sterilising filtration and the aseptic process simulation programme. The comparison with Swissmedic's Q&A shows how a national starting point has developed into an internationally harmonised interpretation.

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Singapore Added to the List of Recognised third Countries for Importation of APIs

The EU Commission adopted a decision that the regulatory and GMP framework in Singapore for APIs is equivalent to that in the EU. This decision allows the EU to rely on the quality oversight of active substances produced in Singapore.

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Failed GMP Training in 2026: Further GMP Training Deficiencies in FDA Warning Letters

Product quality, regulatory compliance, and patient safety all depend on qualified staff. However, insufficient employee training continues to be a frequent finding in FDA inspections in 2026. What are the FDA's expectations for an effective GMP training?

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