Things to consider while setting up your Quality Management System

1. THINGS TO CONSIDER WHILE SETTING UP YOUR QUALITY MANAGEMENT SYSTEM https://gxpcellators.com/

2. GxP Cellator Quality Management System (QMS) is an essential requirement at all drug development and commercialization stages. At different stages, i.e., non-clinical, earlier clinical, to later clinical, the regulatory bodies have specific needs, which companies must control through a robust QMS.

3. 01 Selection of applicable regulations GAP Assessment 03 The selection of relevant regulations is the first step before designing the QMS. After selecting the applicable regulation(s), QA, along with the management, should perform a detailed GAP assessment. Designing of the proposed organizational chart and assignment of responsibilities 02 04 QMS Structure Designing a QMS structure is an important step that helps design the critical modules of the QMS and assign the QMS-controlled nomenclature to each document. Designing a proposed organization chart and assigning the responsibilities to smoother preparation, review, and approval of the QMS related documentation is one of the key points to consider before designing the QMS QMS-controlled

4. 05 Selection of controlled templates Regulatory reference 06 All the QMS-controlled documents must be prepared using the QMS-controlled dedicated templates. Every document prepared under QMS must have a rationale, and the document author must provide a reference to the applicable regulatory segment/clause(s) in those documents. 07 Risk/Impact assessment Each document prepared under QMS must include a risk/impact assessment-based approach.

5. THANKS FOR READING At GxP Cellators Consultants Ltd., we are experts in setting the QMS. Visit Now: https://gxpcellators.com/