WebJan 17, 2024 · The information on this page is current as of Jan 17, 2024. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 211.170 Reserve samples. (a) An appropriately identified reserve sample that is representative of each lot in each shipment of each active ingredient shall be retained. WebJun 15, 2024 · OBJECTIVE: The purpose of this SOP is to lay down a procedure for Disposal of Left Over Test Samples. SCOPE: This SOP is applicable to dispose the Left Over …
Responsibility in Manufacturing, Retained Samples Requirements
WebOct 1, 2024 · PROCEDURE: 6.1 Collect required quantity of retain sample from Raw material received. 6.2 Take the sample in lain and black poly bag (in case if light sensitive … Web5.4.1 Retention Sample shall be kept for all the batches of API’s. 5.4.2 Quantity of sample necessary for two complete analyses shall be drawn as Retention sample. 5.4.3 Retention … hunter original insulated snow boot short
8 Standard Operating Procedure (SOP) Examples Indeed.com
WebStandard Operating Procedure: SOP GCHEM-302 Title: The Retention and Storage of Biochemistry Samples and Records. GCHEM-302 1. APPLIES TO: All MLA’s, BMS’s and … WebJun 20, 2024 · Retained Sample Quantity SOP. 1.0 PURPOSE: 1.1. To ensure retention of materials and finished product for future testing. 2.0 SCOPE: 2.1. This procedure applies to all materials and finished products being used in___________Pharmaceuticals. 3.0 RESPONSIBILITY: Webquality of the data generated are considered to be essential documents and should be retained. The sponsor’s and any CRO’s quality management system should have procedures (e.g. standard operating procedures (SOPs)) in place to manage all aspects of the TMF to assure that the TMF is complete, legible and accurate. hunter original insulated anorak