5. GLOSSARY

ICH and ISO definitions are used in ICH Q10 where they exist .For the purpose of ICH Q10 , where the words “ requirement ” , requirements”or“necessary”appear in an ISO definition.Where no appropriate ICH or ISO definition was available , an ICH Q10 definition was developed .Capability ? of ? a ? Process : Ability of a process to realise a product that will fulfil the requirements of that product .State ? of ? Control : A condition in which the set of controls consistently provides assurance of continued process performance and product quality . ( ICH Q10 ).