Ensuring that there's steadiness info to assistance retest or expiry dates and storage conditions on APIs and/or intermediates, the place appropriateUncooked products for intermediate and API production ought to be weighed or measured under ideal disorders that don't influence their suitability to be used. Weighing and measuring equipment really sh
If bulk deliveries are created in nondedicated tankers, there really should be assurance of no cross-contamination through the tanker. Means of delivering this assuranceIn which appropriate, The steadiness storage disorders must be consistent with the ICH guidances on security.Any deviation from proven methods really should be documented and descri
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