Glossary Terms (Simple List)
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Package integrity
Is the measure of the ability of the package to prevent product loss or maintain product sterility and the ability to maintain the internal environment (2). (TR86)
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Packaged Raw Material for Single-Use
Procurement of a product such as liquid or powder format culture media or buffer and that has been supplied in single-use technology. (TR66)
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Packout
Insulated container that uses refrigerant to keep a product within a specified temperature and time range; see passive system. (TR58)
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Pallets
Pallets are flat transportation structures that are used in the efficient shipping, warehousing and in-plant distribution of goods. A loaded pallet may be moved using a fork lift or pallet jack. They are usually 48 x 40 inches in dimension. They are most commonly constructed of wood but may be plastic, metal or even paper. (TR55)
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Parameters
(TR14)
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Parameters (Critical Operational Parameter)
An input process parameter that should be controlled within a meaningful, narrow operating range to ensure that API quality attributes meet their specifications. Although parameters with wide operating ranges may also impact product quality, they are generally easily controlled and not as likely to result in excursions that affect quality and are therefore low risk. [Synonym: critical process parameter (CPP)] (TR14)
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Parameters (Critical Process Parameter (CPP; Synonym – Critical Operational Parameter))
A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality. (TR60)
A process parameter whose variability has an impact on critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality. (TR74)
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Parameters (Key Operational Parameter)
An input process parameter that should be carefully controlled within a narrow range and is essential for process performance. A key operational parameter does not affect critical product quality attributes. If the acceptable range is exceeded it may affect the process (e.g., yield, duration) but not product quality. (TR14)
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Parameters (Key Process Parameter (KPP; Synonym – Key Operational Parameter)
An input process parameter that should be carefully controlled within a narrow range and is essential for process performance. A key process parameter does not affect product quality attributes. If the acceptable range is exceeded, it may affect the process (e.g. yield, duration) but not product quality. (TR60)
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Parameters (Non-Critical Operational Parameter)
All input process parameters that fall outside the definition for critical operational parameter are non-critical. Non-critical operational parameters are divided into key and non-key operational parameters. [For further explanation, see Sub-section 3.3.6 (TR14)