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Pharmaceuticals/temperature excursion during shipping


Dear Anisfeld
I have a lot of a number of batches of bulk soft gelatin capsules shipment that was shipped and received under the specified storage conditions (30° C) but was then left for about 12 days under uncontrolled temperature mostly in the range of thirties with little exceptional time points in the forties....The calculated mean temperature was 32.8 and the MKT was 33.2. As a matter of product history,The accelerated stability study( at 40°C/75%RH) of the product  showed good stability of the product . We have analysed the product and was found complying with the specification that was almost the same as the CoA sent along with the shipment. It is always stated in the guidelines that "accelerated stability studies can be used to assess the effect of short term excursion outside the label storage conditions such as that might occur during shipping". How would you evaluate the situation of the shipment, can we proceed forward in completing the remaining manufacturing processes (blistering and packaging). Do you have any advice or measures that should be done before that???
Kindest regards,,,,,M.E

Dear Mohammed:

If your 40oC accelerated stability shows no impact of higher temperatures on product over 6 months, AND if you meet the USP definition (USP39) of "controlled room temperature"

10.30.60. Controlled Room Temperature
“Controlled room temperature” indicates a temperature maintained thermostatically that
encompasses the usual and customary working environment of 20 to 25 (68 to 77 F);
that results in a mean kinetic temperature calculated to be not more than 25 ; and that
allows for excursions between 15 and 30 (59 and 86 F) that are experienced in
pharmacies, hospitals, and warehouses. Provided the mean kinetic temperature remains in
the allowed range, transient spikes up to 40 are permitted as long as they do not exceed
24 hours. Spikes above 40 may be permitted if the manufacturer so instructs. Articles may
be labeled for storage at “controlled room temperature” or at “up to 25 ”, or other wording
based on the same mean kinetic temperature. The mean kinetic temperature is a calculated
value that may be used as an isothermal storage temperature that simulates the
nonisothermal effects of storage temperature variations."

then, in my personal opinion, the product can be released for sale.

I hope this helps,


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Michael Anisfeld


Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements


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