ICH Q1


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Analytical worksheet

The analytical worksheet is an internal document to be used by the analyst for recording information about the sample, the test procedure, calculations and the results of testing. It is to be complemented by the raw data obtained in the analysis. Purpose The analytical worksheet contains documentary evidence either: To confirm that the sample being examined is in accordance with the requirements. To support an OOS result. Use A separate analytical worksheet should usually be used for each numbered sample or group of samples. Analytical worksheets from different units relating to the same sample should be assembled together. Content The analytical worksheet should provide the following information: The registration number of the sample. Page numbering, including the total number of pages (and including annexes) The date of the test request. The date on which the analysis was started and completed The name and signature of the analyst A description of the sample...
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QMS

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A Quality Management System (QMS) is defined as a set of interrelated or interacting elements such as policies, objectives, procedures, processes, and resources that are established individually or collectively to guide an organization. In the context, organizations engaged in the storage and distribution of materials and products should establish, implement, monitor, and maintain a QMS that allows the delivery of materials, products, and services with the requisite quality and safety. This includes ensuring the availability of resources needed to be in compliance. For this reason, each organization should define the scope of its QMS and present it in the form of a quality manual. QMS framework for all supply chain partners that can be integrated into other management systems (e.g., environmental, occupational health, and safety) Quality management system Management Responsibility QMS Planning Communication Documentation Control of documents Document categorie...
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