There was some concern in the United States when a government investigation turned up findings that almost 23 percent of pharmaceuticals distributed in the country are of unknown efficacy. This consequently put the integrity of the cold chain under the spotlight. There was much question as to how compliant the related businesses were to the pertinent standards and regulations. Understandably, emphasis was then placed on the importance of cold chain validation.
It was a wake-up call to all businesses involved in the cold chain process, not only in the US but all over the world. Australian companies and regulatory bodies regarded the news as motivation to further persevere in ensuring that the integrity of our cold chain remains intact. Certainly, related agencies made sure that cold chain validation was a priority in their audit list. The efficacy of many temperature sensitive drugs, medicines and vaccines can be a matter of life or death if the drugs prove to be ineffective due to them having not been stored or transported under temperature controlled conditions. Besides the possible tragedies that could stem from products being compromised in storage or in distribution, there are also the other crucial matters of reputation and liability.
Companies can consult literature on the appropriate legislations, but it would be more prudent to get assistance from industry experts. Cold chain consultants like Coolpac have the knowledge, equipment, and experience necessary to develop, test, and implement cold chain systems for pharmaceutical and biotech companies. They have the appropriate testing chambers and tools, data-recording equipment, and other related equipment, all calibrated to pass international standards.
Cold chain specialists are aware that temperature mapping is not the be-all and end-all of the process as it is an indication of the temperature within a warehouse, fridge or freezer at a particular point in time but it does help to highlight and fix issues. Cold Chain Consultants can help clients in all areas of cold chain management from meeting regulation requirements and implementing quality management systems to validating and qualifying equipment and facilities as well as designing and validating cold chain mechanisms. They also advise regarding logistic options and best distribution practices.
If you need proof of your compliance with official standards, these cold chain consultants can supply you with all the necessary documentation pertaining to protocol, validation or qualification reports, engineering reports, as well as packing details vis-a-vis photos and videos.
The protection of regulatory controlled drugs from exposure to unsuitable climatic conditions and the strict adherence to cold chain compliance standards are duly addressed in legislation in almost all countries. To protect your business, your associates, and your consumers, make sure you undergo validation.