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).