FDA provides information about influence of wheather conditions on biological products
On its website the US Food & Drug Administration informs about the "Impact of severe weather conditions on biological products:
"Most biological products require specific storage conditions, as indicated in the product labeling, to maintain their safety, purity, and potency. These products include bacterial and viral vaccines, allergenic extracts, plasma derivatives, and other products requiring refrigeration or frozen storage, as well as products that can be stored at controlled room temperature (i.e., not exceptionally cold or hot). When there is an electrical power failure, whether due to accident, equipment failure, or disruption in the electrical power grid, the temperature control systems for product storage may not function. For example, on August 14, 2003, the northeast region of the country experienced a power outage lasting from one to several days, and some health professionals were uncertain what to do with products that they had in storage. Power failures are not only a concern regarding storage in a facility, as failure of the refrigeration or freezer unit on a carrier (e.g., truck) while the products are in transit may also occur. The information below may assist interested persons in determining what to do with their biological products in the event of a power failure.
CBER is providing interested persons with information concerning the storage and use of temperature-sensitive biological products that have been involved in a temporary electrical power failure or flood conditions. These information includes:
- Vaccines Requiring Refrigeration or Frozen Storage
- Other Non-Blood Biologicals Requiring Refrigeration or Frozen Storage
- Blood Products and Plasma Derivatives"
To find more detailed information please read "Impact of Severe Weather Conditions on Biological Products".
Related GMP News
15.09.2025When Training Falls Short: FDA Findings on GMP Training Deficiencies in 2025
15.09.2025Dealing with Systems without Audit Trail Functionality
15.09.2025Why is RCA (Root Cause Analysis) so important?
10.09.2025The Use of Hoses in Pharmaceutical Production
10.09.2025Revision of EU-GMP Chapter 1 planned with Consultation Phase
10.09.2025Audit Trail Review by the QP / Dealing with a Lack of Justification