WebAug 18, 2024 · The regulations “ [S]pecifically, 21 CFR 320.38 and 320.63 require the applicant (or its CRO) to retain reserve samples of the test article and reference standard used in conducting any in vivo BA and in vivo or in vitro BE study that support the approval of its application or supplemental application.”. And they specifically state that the ... WebAug 21, 2016 · Chapter 26: Reserve Samples and Retains. 21 CFR 211.170 requires an appropriately identified reserve sample that is representative of each lot in each shipment of each active ingredient. The reserve sample consists of at least twice the quantity necessary for all tests required to determine whether the active ingredient meets its established ...
Reserve Definition & Meaning Dictionary.com
WebApr 1, 2014 · The purpose of keeping retention samples is to support or verify the food products shelf life period, quality, microbiological, physical and chemical attributes. Retention samples may also be used as part of complaint investigations. When keeping retention samples of your food product, keep in mind the following: Web11.7 Reserve/Retention Samples 12 Validation 12.1 Validation Policy 12.2 Validation Documentation 12.3 Qualification 12.4 Approaches to Process Validation 12.5 Process Validation Program 12.6 Periodic Review of Validated Systems 12.7 Cleaning Validation 12.8 Validation of Analytical Methods 13 Change Control dtsflag is 0x00a09c82
Q 7 Good Manufacturing Practice for Active Pharmaceutical …
WebNov 27, 2024 · Specifically, the reserve samples that you maintain must: Be held using the same container-closure system in which the packaged and labeled dietary supplements were distributed [21 CFR 111.83 (b) (1)]. Be identified with the appropriate batch, lot, or control number [21 CFR 111.83 (b) (2)]. Be retained for one year past the shelf life date (if ... WebTo keep back; to retain; not to deliver, make over, or disclose. (v. t.) Hence, to keep in store for future or special use; to withhold from present use for another purpose or time; to … WebReserve means to retain something and to keep something for a particular purpose or time.. I want to use reserve but with the meaning of retaining something initially/in … dts financial