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quality risk management: an overall and continuing systematic process for the assessment, control, communication and review of risks to the quality of a pharmaceutical product or medical device across the product lifecycle in order to optimize its benefit-risk balance. note: definitions of ‘past’ and ‘frequent’ for calculation of the probability of occurrence of product quality complaints (pqcs) shall be customized by considering at a minimum, the actual frequency of occurrence of such events. however, if the same site receives an average of 30 recalls in a year, it is more logical to define ‘past’ as ‘6 months’ and ‘frequent’ as – ‘more than 5’.
quality system has weak controls to detect the quality-related event after its occurrence and prevent it from recurring (e.g., systems are not validated). the quality system has controls and will possibly detect the quality-related event after its occurrence and avoid it from recurring (e.g., statistical process control is used in the process, but the product undergoes final inspection off-line). in case of equipment / instrument/ utility. year such as 12, 13,14, zzz: serial no such as 001,002….. department codes are the following : validation assessment of the efficacy of critical control points and the ability to consistently execute them for any process eliminate, reduce or control potential failures highly dependent upon a strong understanding of the product, process and/or mrs. janki singh is professional pharmaceuticals blogger, founder and author of pharma beginners, she has rich experience in pharmaceutical field.
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