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Why Validate?
The Pharmaceutical and Medical Device industries have many national and international regulatory requirements that they must satisfy to ensure that they are allowed to continue to manufacture and sell their products.
Satisfying the regulatory commitment is a very expensive process. All Pharmaceutical and Medical Device companies invest a large proportion of their operating budgets simply satisfying these regulatory requirements.
Validation is part of these regulatory requirements. The FDA defines validation “as establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
Simply put, this means to prove that a process, system or equipment will do what it is designed to do time after time every time.
Each Pharmaceutical or Medical Device manufacturer must validate its process and equipment before they can accept commercial sales.
What is Validation?
Since the Mid-1970s, Validation considerations have played an increasingly dominant role in the manufacture and quality assurance of U.S. health care products. But the origins of validation in the United States goes back to 1906 when the Food and Drug Administration (FDA) was formed in response to, of all things, a book!
The book, called “The Jungle”, written by Upton Sinclair depicted conditions in the Chicago meat markets that were so bad that Americans cut their meat consumption by over 50%.
This book had a dramatic effect on public opinion. Unfortunately, the conditions that the book described were not exaggerated and many people died from diseases they contracted as a direct result of the conditions under which their meat products were prepared and stored.
At the same time, Joseph Heinz (of the “57 varieties” fame) was busy lobbying the US Congress to pass laws governing conditions within food processing facilities. Mr. Heinz was a very responsible employer who provided his employees with excellent working conditions and benefits including one of the first company pension plan ever to be established. He also insisted that all processing areas be maintained to a high standard of order and cleanliness.
The public outcry over the book and the ensuing drop in meat sales was comparable to the recent “Mad Cow” scare in the UK. This, coupled with the incessant lobbying of Joseph Heinz prompted then President Teddy Roosevelt to persuade congress to pass the first Food and Drug Act.
In 1962, the FDA issued a first set of Good Manufacturing Practices (GMP) for the Pharmaceutical and Medical Device Manufacturers as a means of assessing the quality procedures and practices of a company.
This came as an after effect of the Thalidomide incident. Clinical testing of products prior to commercialization was introduced and any potential side effect now had to be disclosed to physicians as well as to the general public.
The 1962 GMPs delineated guidelines on how to produce, package, store, market, and distribute Pharmaceuticals and Medical Devices.
Finally, in 1976 the FDA proposed a whole new set of current Good Manufacturing Practices (cGMP’s). After three years or so of public hearings as part of “due process” to convert the new regulations into law, these proposals were declared substantive, which meant that non-compliance with the new regulations had now become a prosecutable criminal act.
It is important to keep in mind that the FDA is an enforcement agency. Their representatives are called “investigators” not inspectors. They have the authority to ask for any record they feel may be pertinent to an audit or a review they are carrying out and they don’t mind flexing their muscles to obtain what they want.
Today, all industrialized nations have similar government bodies that act as the FDA acts. In fact most of the worlds regulatory agencies have very similar regulations and requirements.
All our customers are therefore required by law to conform to the cGMP’s as they apply to their specific processes and products. And just as importantly, they must prove product purity, safety, efficacy, and consistency… How does all of this tie in to Validation? Well, simply put, validation or proving that the system or equipment will do what it is designed to do time after time every time will ensure product purity, safety, efficacy, and consistency.
Who is responsible for Validation?
Ultimately it is up to the manufacturer of any Pharmaceutical or Medical Device product to prove that their products and processes are safe. After all, they are the ones making and selling these products.
They do so by documenting then systematically challenging and testing the methods and practices that they employ to produce their products.
Failure on their part to comply with the cGMP’s, or more accurately failure on their part to provide evidence of compliance with the cGMP’s can result in one or a combination of several sanctions. These include suspension of commercial licenses (it is difficult to generate profits when you are not allowed to sell a product), costly legal cases and financially damaging product recalls or delays. And, in severe cases compulsory plant closures until the problems are addressed.
The FDA can also prosecute individuals who willingly contravene the regulations and although rare, individuals may be subject to imprisonment if convicted. The FDA also has the power to ban convicted individuals from employment by any pharmaceutical company with interests in the USA.
What is important here is that evidence of compliance must be available. This means written records must exist for just about everything.
Our clients are required to document in great detail what they need (Functional Requirements Specifications), what equipment suppliers provide (Detailed Design Specifications), (design and programming written procedures), (complete and detailed Machine Manuals with all third-party technical documentation), and proof that the equipment will operate as expected (Factory Acceptance Testing) time after time every time (Validation).
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