Design Control, often referred to as product quality planning, has been practiced for many decades. In fact, if you have ever taken part in the review and approval of a technical document, realize that product development occurs through several stages of development with increasing complexity, andhave been involved in the evaluation, testing, and analysis of these lifecycle stages, then you have been involved in and practiced Design Control. Design Control, in simple terms, is a systematic defined sequence of events that occur in the product development and commercialization to ensure that the product meets user requirements.
The ICH Q10 Model defines the pharmaceutical lifecycle as consisting of four phases-product development, technology transfer, commercialization, and product discontinuation.
The ICH Q10 Model defines the pharmaceutical lifecycle as consisting of four phases-product development, technology transfer, commercialization, and product discontinuation.