Hi Sir,
All the raw materials stored below 25degrees but most of the raw materials reached at factory in closed condition. If any strong reason the vehicle not unloaded for 5days what is materials condition.
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Hello and welcome!
Raw materials that require specific temperature, humidity or any other special storage condition must be kept under these conditions during transportation.
For example: if you have a raw material that needs to be between 2 to 8 °C (refrigerated) then there must be controls and verfications to ensure that its distribution process was controlled and that the product was kept at that temperature range. This is called cold chain dsitribution validation, but the idea is similar.
If there is no evidence of this process or if those 5 days exceed the time and conditions validated to ensure the matierial integrity and stability; then that material should be put into quarantine until an investigation and risk asessment is done.
I hope this is useful. Regards!
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Thank you Sir
Hi,
Please refer USP Chapter <1079> “Good Storage and Shipping Practice” in this chapter all are condition mentioned.
Storage statements should be based on the stability evaluations of the Pharmacopeial drug substances and in accordance with national and international requirements.
Room Temperature Storage Statements—
For products with a storage statement reading, “Store at controlled room temperature,” the labeling should read as follows on the package insert: “Store at 20 C to 25 C (68 F to 77 F) excursions permitted between 15 C and 30 C (between 59 F and 86 F). Brief exposure to temperatures up to 40
C (104 F) may be tolerated provided the mean kinetic temperature does not exceed 25 C (77
F); however, such exposure should be minimized.”
On the immediate container label, the following may read for controlled room temperature (CRT): “Store at 20 C to 25 C (68 F to 77 F), excursions permitted between 15 C and 30 C (between 59 F and 86 F).”
Cool Storage Statement—
The storage statement for labeling may be as follows: “Store in a cool place, 8 C to 15 C (46 F to 59 F).”
Refrigerator Storage Statement—The storage statement for labeling may be as follows: “Store in a refrigerator, 2 C to 8 C(36 F to 46 F).”
Freezer Storage Statement—
The storage statement for labeling may be as follows: “Store in a freezer, –25 C to –10 C (–13 F to 14 F).”
See the General Notices for all other applicable storage conditions, such as Storage Under Nonspecific Conditions and store in a Dry Place.
Additional cautionary statements to protect the Pharmacopeial drug product from extreme temperature and humidity conditions may be included on the container label and package insert, as the manufacturer desires.
Thanks,
Kamlesh
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Dear Kamlesh
Thanks for your informative answer. Is there any specific conditions for humidity in a warehouse?
Storage and Warehousing
It is important to consider a pharmaceutical product’s exposure to humidity throughout the entire production process. In storage and warehousing, deviations from the desired temperature and humidity conditions must be minimized, controlled, and documented.
Unfortunately, temperature and humidity excursions are almost inevitable, but automated control of HVAC and humidity control systems will improve response and recovery, and also can provide historical and trend data to track these excursions.
Although minor deviations probably have no significant impact, it’s important to consider the effects of temperature or humidity deviations on every item held in storage. This can be a daunting task, as it is not unusual for warehouses to contain hundreds or even thousands of different inventory items.
It also is worth considering that new items will be added in the future, which will require some form of assessment. The impact assessment, therefore, has the potential to become an enormous task.
It is easier to ensure temperature and humidity are controlled within defined limits (e.g. 72°F/22°C at 50% RH) supported by automatically generated logs. Keep in mind that varying air handling strategies may be necessary based on the location and local environment of each storage facility.
Many thanks for your prompt reply. I appreciate that. I wonder if there is a defined range for humidity in the APIs storage Area?