How we can validate the hold time of dispensed raw material used for sterile preparation?
For dispensed raw materials which are non-sterile intended to be used for manufacturing sterile products the hold time should be based on the control of bio burden in it. Therefore, hold time should be as minimum as possible. It should be determined by determining bio burden at time intervals during storage/ holding period and comparing the microbiological results with the initial baseline. This is in addition to the other critical parameters to be analysed which may have impact upon storage or holding, such as moisture content.
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7 days hold time of dispensed raw material is possible?
Ideally, 7 days is a very long period. This reflects on poor production planning and lack of co-ordination between Production and Warehousing departments.
May we store for 7 days if environmental condition is OK for that product?
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Under exceptional conditions such as some break down or failure of systems in the manufacturing areas, you may store dispensed raw materials for longer time, provided you should have sufficient quality data to prove that under those storage conditions and in secondary containers used for dispensing of the raw materials it’s quality attributes are unchanged meeting the specification requirements.
However, this should not be a routine practice.