For incoming production materials, identity tests and related methods should be used as described in the relevant sections of a Pharmacopoeia monograph, in an approved regulatory filing or in an in-house specification (including method/analytical procedure) [ICH Q7, 7.30]. When available, a discriminating test should be considered for identification testing. The visual examination of a label or the material is not considered sufficient except in the cases described in [ICH Q7, 7.32].
Is it possible to extend the expiry date or retest date of a raw material and what is the acceptable practice to determine how
Manufacturing and labelling of raw materials for use by API manufacturers is outside the scope of ICH Q7. As such, retest and expiry dates, as defined in ICH Q7, do not strictly apply to raw materials and may be used in a different manner by the raw material supplier. Expiry date, as defined in the glossary of [ICH Q7, 20], applies specifically to the API. API manufacturers may re-evaluate [ICH Q7, 7.5] and then use a raw material after the ‘expiry date’ or ‘retest date’, based on an appropriate scientific and risk-based justification (e.g., understanding of material attributes, testing, and stability). Similar justifications may be used to extend the date by which the material should be reevaluated. It is the responsibility of the API manufacturer to ensure the raw materials are appropriate for the intended use at the time of use.
Can yield ranges defined for the first batch differ from latter batches within a campaign?
Yes. Differing yield ranges [ICH Q7, 8.14] may be described and justified in the manufacturing procedure/master batch record explaining the ranges [ICH Q7, 6.41]. For example, the first batch in the series of production of batches of the same material (campaign) may leave residual material in the equipment, resulting in a low yield in the first batch and contributing to an increased yield in a subsequent batch of the campaign.
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