Glossary Terms (Simple List)
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Product Complaint
A complaint by a customer is any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a product on the market. Complaint Systems are used to collect and categorize information on the condition of regulated products on the market with which consumers are dissatisfied. (TR55) (TR67)
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Product Lifecycle
All phases in the life of a product from the initial development through marketing until the product’s discontinuation (ICH Q8[R2]. (TR54) (TR54-5)
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Product Recalls
Product recalls are actions taken by a firm to remove or correct one or more batches of product from the market that are considered to be in violation of one or more laws or rules in that country. Recalls may be conducted on a firm’s own initiative, by Regulatory Agency request, or by order under statuatory authority. These drug recall classifications are specified by the FDA. (TR55)
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Product Stream
The process flow in which a product is manufactured.(TR43)
The process flow in which a product is manufactured that is often described in a process map.(TR 76)
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Product-specific Design Approach
A sterilization design approach that is based on the characteristics of the bioburden (on or in the load) and the heat sensitivity of the product that delivers the lethality needed to achieve a PNSU of 10-6 on or in the items to be sterilized. (TR01) (TR3) (TR30)
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Programmable Logic Controller (PLC)
A digital electronic apparatus with a programmable memory for storing instructions to implement specific functions, such as logic, sequencing, timing, counting and arithmetic, to control machines and processes. (TR48)
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Proportional Control Valve
A device that is designed for precise positioning and continuous movement, typically in response to a varying analog signal. [Synonym: Modulating Valve] (TR48)
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Proportional, Integral, Derivative (PID)
Control action in which the output is proportional to a linear combination of the input, the time integral of input, and the time rate-of-change of input. (TR48)
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Prospective Process Validation
Validation conducted prior to the distribution of either a new product or a product made under a revised manufacturing process where the revisions may affect the product’s characteristics. (TR42) (TR74)