Pharma GLP

Management Resposibility Senior management is responsible for assigning a management representative to develop and maintain the QMS, acting as representative in all issues concerning quality. Conflicts of interest should be avoided, and the management representative shall be given sufficient authority. The necessary resources shall be available to the management representative, and the responsibilities placed on any one individual shall not be so extensive as to present any risk to product quality. Senior management should ensure: The QMS takes into account all applicable guidelines and regulations Management reviews are performed on a regular basis The quality manual, quality policies, and quality objectives are all in place Job descriptions, responsibilities, and authorities are clearly understood within the organization All necessary resources are provided Communication flows are timely within the organization and the supply chain Quality Management Syste...

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...

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...