// ROBOTICS AND SMART FACTORIES TERM

Good Manufacturing Practice

A set of guidelines and regulations that ensure products are consistently produced and controlled according to quality standards, particularly in industries like pharmaceuticals and food.

Good Manufacturing Practice — illustration from Wikipedia
Image via Wikipedia

TECHNICAL DEFINITION

Good Manufacturing Practice (GMP) refers to a system of regulations and guidelines enforced by regulatory bodies (e.g., FDA) to ensure that products like pharmaceuticals, food, and medical devices are consistently produced and controlled according to quality standards.

BACKGROUND

Design for manufacturability (DFM), also known as design for manufacturing, is the engineering practice of designing a product to reduce the cost of its manufacture and to make its manufacture easier, and often the two aspects are intertwined. Common factors that affect manufacturability include the type of raw material, the form of the raw material, dimensional tolerances, and secondary processing such as finishing.

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SYNONYMS & ALIASES

  • GMP
  • cGMP (current GMP)
  • Manufacturing Standards
  • Quality Guidelines

USAGE NOTE

Adherence to GMP is legally mandated in many industries to ensure product safety and efficacy.

DEVELOPERS

Organizations developing technology related to Good Manufacturing Practice.

  • Veeva Systems

    Veeva Systems provides cloud-based software for the life sciences industry, offering solutions for quality management (QMS), regulatory affairs, and clinical operations, all critical for maintaining Good Manufacturing Practice.

  • MasterControl

    MasterControl specializes in enterprise quality management software (EQMS) for regulated industries, helping companies automate and manage their quality processes to achieve and maintain GMP compliance across the product lifecycle.

  • Siemens Digital Industries Software

    Siemens offers a comprehensive portfolio of software solutions, including Manufacturing Execution Systems (MES), Quality Management Systems (QMS), and Product Lifecycle Management (PLM) tools that enable manufacturers to implement and adhere to GMP standards through digitalization and automation.

  • SAP

    SAP provides enterprise resource planning (ERP) software that includes modules for quality management, production planning, and supply chain management, essential for controlling manufacturing processes and ensuring compliance with GMP regulations.

  • Rockwell Automation

    Rockwell Automation delivers industrial automation and digital transformation solutions, including control systems, manufacturing execution systems (MES), and analytics, which are vital for ensuring consistent, traceable, and GMP-compliant manufacturing operations.

  • Thermo Fisher Scientific

    Beyond laboratory instruments, Thermo Fisher Scientific provides Laboratory Information Management Systems (LIMS) and Chromatography Data Systems (CDS) that are crucial for managing laboratory data, ensuring data integrity, and supporting quality control processes in GMP environments.

  • Dassault Systèmes

    Through brands like DELMIA and BIOVIA, Dassault Systèmes offers solutions for manufacturing operations management, scientific informatics, and product quality, enabling companies to manage complex processes, ensure data integrity, and maintain GMP compliance.

  • ValGenesis

    ValGenesis provides an Enterprise Validation Lifecycle Management System (VLMS) that automates and standardizes the validation process for systems, equipment, and processes, which is a critical requirement for maintaining GMP compliance in regulated industries.

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