SCADA Project

  The concept of Good Engineering Practice (GEP) can be determined as follows:
“Established engineering methods and standards that are applied throughout the project’s life cycle and which contribute to the achievement of cost-effective solutions."

  SCADA Project

  The design of control systems is carried out with the use of the Good Automation Manufacturing Practice (GAMP 5) standards. These standards are designed to help suppliers of automated systems in the pharmaceutical industry to ensure that the systems are properly designed and are supplied with the proper documents, confirming the system’s compliance with the user’s specifications.

  NOTE. GxP –This group of standards (GMP, GEP, GLP, GSP, GCP) is relating to the pharmaceutical industry.

  The advantages of applying of the basic GAMP 5 standards for process control systems:

• Comprehensive review of the modern practices for process control systems.
• Reduce the cost and time required for developing the necessary process control systems.
• Use of good practice in the development and management of projects through the implementation of process control systems that meet regulatory standards.
• Coordinated approaches to integrated and autonomous systems.
• Detailed definition of engineering steps.
• Detailed guidance on the formation of the specification of user requirements (technical specifications).
• Detailed guidance on the structure and functionality of process control systems.
• Detailed guidance on the required services for regulated environments.
• Allocation of duties and responsibilities between the user and the supplier.
• Detailed guidance on the implementation of Supplier documentation in the User’s validation documentation. Modified and extended audit of suppliers to ensure their compliance with the regulations.
• Helps to avoid extensive and time-consuming retrospective audit on the results of the activity of the process control systems, but, if necessary, provides application-based approach to risk assessment.