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GMP News

Templates for Shortage Prevention and Mitigation Plans issued by EMA

On 18th of June 2024, the EMA has issued templates for Shortage Prevention Plans (SPPs) and Shortage Mitigation Plans (SMPs). Marketing authorization holders in the European Union/European Economic Area are encouraged to create Shortage Prevention Plans to minimize the risk of medicinal shortages.

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FDA Warning Letter: GMP Requirements also apply to HPLC Analyses for Internal Use

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Chinese drug manufacturing facility for significant CGMP violations. Among other issues, the firm performed in-house HPLC testing for internal use without audit trails and could not provide validation reports for these methods. Additionally, the company failed to adequately explain the purpose of this testing.

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10 points on how the FDA's CDER monitors the Quality of Medicinal Products

The FDA's Center for Drug Evaluation and Research (CDER) has compiled a 10-point overview of how it fulfils its task of ensuring the quality of medicinal products. What are these 10 points?

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