The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Supplier Qualification and Audits Comprehensive Guide to Supplier Qualification and Audits in Medical Device Manufacturing 1) Purpose This SOP outlines the procedures for evaluating, qualifying, and auditing suppliers to ensure that raw materials, components, and services provided meet quality and regulatory requirements. Establishing a robust supplier qualification process ensures the reliability of the…
SOP for Raw Material Inspection and Approval Comprehensive Guide to Raw Material Inspection and Approval in Medical Device Manufacturing 1) Purpose This SOP defines the process for inspecting and approving raw materials used in the manufacturing of medical devices. The objective is to ensure that all materials meet predefined quality and compliance standards, minimizing risks…
SOP for Prototyping Medical Devices Comprehensive Guide to Prototyping Medical Devices 1) Purpose The purpose of this SOP is to outline a systematic approach for prototyping medical devices. Prototyping ensures that concepts are translated into functional models, enabling validation of design features, testing of functionality, and identification of potential design improvements. This process is essential…
SOP for Medical Device Design and Development Comprehensive Guide to Medical Device Design and Development 1) Purpose The purpose of this SOP is to establish a clear, systematic framework for the design and development of medical devices. This framework ensures compliance with applicable international and local regulatory standards, fosters innovation, minimizes risks, and guarantees that…