Quality Regulatory Updates In Brief: EMA, FDA, EDQM And WHO
EMA proposes updating methods for water for injection; FDA clarifies policies on first responders under new drug tracing law; EDQM lists top 10 API deficiencies; and WHO invites API manufacturers to participate in prequalification program.
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The European Medicines Agency is inviting stakeholder feedback on a proposal to allow reverse osmosis as an alternative to steam distillation for making water for injections (WFI) for pharmaceutical manufacturing. EMA also would expand its water quality guideline to cover vaccines and advanced therapy medicinal products such as cell and gene therapies.
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.
The US FDA managed to issue 94 drug GMP warning letters last year despite the pandemic, with fewer expected for 2021. Top issue areas included lack of sterility assurance, nitrosamine impurities, poor data integrity and basic GMP failures.