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This direction just isn't intended to define registration and/or filing specifications or modify pharmacopoeial demands. This direction won't affect the flexibility of your accountable regulatory agency to establish certain registration/submitting needs about APIs within the context of marketing/producing authorizations or drug programs. All commit

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What's sterility testing? Sterility testing is created to reveal the existence or absence of extraneous practical contaminating microorganisms in biological parenterals suitable for human use.Outsourcing biosafety testing, characterization and products specific assay growth to Sartorius removes these barriers and helps you to center on drug develop

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