Pharmaceutical Validation is the implementation of a quality system approved by the FDA.
It is designed to ensure that every part of a pharmaceutical installation meets the standards during every stage of its lifecycle (design, construction, startup, production, maintenance and decomissioning). Keywords are "Good practices" and "Traceability". It is a very large field and some parts of it may not require much technical knowledge. However, if you have to prove that a certain program in a controller will act in certain ways, it may be useful to at least know how these things work in order to design a testing procedure to prove (validate) that this is true.
Pharmaceutical Validation is always teamwork. Mechanical, electrical, automation, control, process and software engineers each have to assist the validation officer with all the necessary documentation and testing. The only person that is not really a technical specialist is the validation officer. However to be successful, he must have a broad knowledge of technical stuff without real specialized knowledge in a specific field. His main job task is the interfacing between the technical staff and the FDA and therefore he is responsible for the final FDA approval of the entire project.
It is designed to ensure that every part of a pharmaceutical installation meets the standards during every stage of its lifecycle (design, construction, startup, production, maintenance and decomissioning). Keywords are "Good practices" and "Traceability". It is a very large field and some parts of it may not require much technical knowledge. However, if you have to prove that a certain program in a controller will act in certain ways, it may be useful to at least know how these things work in order to design a testing procedure to prove (validate) that this is true.
Pharmaceutical Validation is always teamwork. Mechanical, electrical, automation, control, process and software engineers each have to assist the validation officer with all the necessary documentation and testing. The only person that is not really a technical specialist is the validation officer. However to be successful, he must have a broad knowledge of technical stuff without real specialized knowledge in a specific field. His main job task is the interfacing between the technical staff and the FDA and therefore he is responsible for the final FDA approval of the entire project.
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Last Updated: June 16, 2007
Last Updated: June 16, 2007
What is Validation?
What is Validation?
