How to define or carry out dispensed material hold time study?How to select different item for study?or any supporting guideline.!
There should be approved protoco or a planl of carrying out hold time study of dispensed raw materials.
All the raw materials to be dispensed and used for manufacturing a batch of specific product as per Master formula should be considered for hold time study.
Generally, such study is conducted during process validation of that product.
For hold time study, the raw materials should be collected in simulated packs or containers as that of actual dispensed raw materials and should be stored in dispensed area or simulated conditions.
During hold time study, the dispensed raw materials should be analysed for critical tests which may have impact of their storage during hold time at specifiedspecified storage conditions, such tests can be determination of moisture content, pH of solution, Solubility characteristics, physical parameters, and microbiological aspects like bio burden.
Thanks Mr. Sajjad and Mr. Sunilrbudhkar
You are welcome