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GMP News

USP Proposes to Revise the Definition of Controlled Room Temperature in Chapter <659>

The United States Pharmacopeia (USP) has published a proposal to revise General Chapter <659> Packaging and Storage Requirements, focusing on the compendial definition of Controlled Room Temperature (CRT). The aim is to better align USP terminology with the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and WHO usage, where “room temperature” is defined as 15–25 °C.

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GDP in Hong Kong: Authority Provides Additional Information

As previously reported, the competent authority in Hong Kong, the Pharmacy and Poisons Board, launched a public consultation on the introduction of Good Distribution Practice (GDP). The consultation has now been completed. The authority has now published additional information in a presentation, which is available for download as a PDF file.

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GDP Non-Compliance Report: Spanish Authority Found 29 Deficiencies During an Inspection of a Wholesale Distributor

The Spanish competent authority has published a new GDP Statement of Non-Compliance on EudraGMDP. An inspection identified 29 deficiencies across the company’s GDP system, including 8 critical and 10 major findings.

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