History
The concept of validation was first proposed by two Food and Drug Administration (FDA) officials, Ted Byers and Bud Loftus, in the mid 1970s in order to improve the quality of pharmaceuticals (Agalloco 1995). It was proposed in direct response to several problems in the sterility of large volume parenteral market. The first validation activities were focused on the processes involved in making these products, but quickly spread to associated processes including environmental control, media fill, equipment sanitization and purified water production.
The concept of validation was first developed for equipment and processes and derived from the engineering practices used in delivery of large pieces of equipment that would be manufactured, tested, delivered and accepted according to a contract The use of validation spread to other areas of industry after several large-scale problems highlighted the potential risks in the design of products. The most notable is the Therac-25 incident. Here, the software for a large radiotherapy device was poorly designed and tested. In use, several interconnected problems led to several devices giving doses of radiation several thousands of times higher than intended, which resulted in the death of three patients and several more being permanently injured.
In 2005 an individual wrote a standard by which the transportation process could be validated for cold chain products. This standard was written for a biological manufacturing company and was then written into the PDA's Technical Report # 39, thus establishing the industry standard for cold chain validation. This was critical for the industry due to the sensitivity of drug substances, biologics and vaccines to various temperature conditions. The FDA has also been very focused on this final area of distribution and the potential for a drug substances quality to be impacted by extreme temperature exposure.
Read more about this topic: Validation (drug Manufacture)
Famous quotes containing the word history:
“What you don’t understand is that it is possible to be an atheist, it is possible not to know if God exists or why He should, and yet to believe that man does not live in a state of nature but in history, and that history as we know it now began with Christ, it was founded by Him on the Gospels.”
—Boris Pasternak (1890–1960)
“Whenever we read the obscene stories, the voluptuous debaucheries, the cruel and torturous executions, the unrelenting vindictiveness, with which more than half the Bible is filled, it would be more consistent that we called it the word of a demon than the Word of God. It is a history of wickedness that has served to corrupt and brutalize mankind.”
—Thomas Paine (1737–1809)
“We don’t know when our name came into being or how some distant ancestor acquired it. We don’t understand our name at all, we don’t know its history and yet we bear it with exalted fidelity, we merge with it, we like it, we are ridiculously proud of it as if we had thought it up ourselves in a moment of brilliant inspiration.”
—Milan Kundera (b. 1929)