Ensuring that there is balance knowledge to assist retest or expiry dates and storage conditions on APIs and/or intermediates, exactly where properThe packaging and Keeping of reserve samples is for the purpose of probable long term analysis of the quality of batches of API and never for upcoming balance screening purposes.The controls used in the
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Upon receipt and just before acceptance, Just about every container or grouping of containers of components ought to be examined visually for appropriate labeling (which include correlation amongst the title used by the provider as well as the in-property title, if these are distinct), container destruction, damaged seals and proof of tampering or