New EMA guideline: environmental risk assessment of pharmaceuticals
On March 21, 2024, the EMA released the new guideline for the Environmental Risk Assessment (ERA) of pharmaceuticals intended for human use.
New EMA guideline: environmental risk assessment of pharmaceuticals
On March 21, 2024, the EMA released the new guideline for the Environmental Risk Assessment (ERA) of pharmaceuticals intended for human use.
Revision of the EMA Guideline on Nitrosamines
In the 20 November 2023 revision of the EMA document, new compounds and new limits were introduced for some existing nitrosamines.
FRANCE: new guidance on substances with endocrine disrupting properties
France, regulation amendments have been made for endocrine disrupting substances.
USA: Proposition 65 update on PFOA and BPA
Proposition 65: New guidelines for certain products containing perfluorooctanoic acid (PFOA) or bisphenol A (BPA).
FDA Guideline's Update on Nitrosamines
The Food and Drug Administration has released new guidance regarding tolerable levels of nitrosamine-related impurities (NDSRIs) in pharmaceutical products.
CCIT in pharmaceutical products: guaranteeing efficacy and safety
Verification of the integrity of container closures is a growing concern in the pharmaceutical packaging industry. Recently, the new version of Annex 1 of the European Union's GMP was introduced, dedicated precisely to the Manufacture of Sterile Medicinal Products.
New US restrictions on drugs containing DEG/EG
Following repeated cases of contamination in the United States, the FDA implemented strict safeguards to prevent the import of products adulterated with DEG/EG.
Plastics in food contact: published the 16th amendment of Reg. 10/2011
Important new updates for the regulatory framework of plastic materials and articles intended for food contact. Several changes were introduced by the 16th amendment of Regulation 10/2011.
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