E03-5201 Material Specifications for GMP Projects

$50.00

The purpose of this document is to describe the design requirements, material of construction, special features and surface finish specification for facility components, process equipment, piping and instrumentation (hereafter known as equipment) for both “direct impact” and “no-Impact” system and equipment.

Description

Purpose of this SOP:

The purpose of this document is to describe the design requirements, material of construction, special features and surface finish specification for facility components, process equipment, piping and instrumentation (hereafter known as equipment) for both “direct impact” and “no-Impact” system and equipment.

GMP Project Design Processes & Documentation

E03-5000 Project Quality System Flowchart – Design

The User Requirement Specification will provide information to the designer to determine suitable material of construction of process equipment. “Product Contact Surfaces” have to withstand:

  • to the properties of raw materials, cleaning agents, in-process and final products;
  • temperature and pressure;
  • hazardous environment (eg flammable, corrosive)..

The document template consists of:

  • a 6-page Standard Operating Procedure
  • Appendix I = Equipment Requirements – the table layout provide a checklist to the technical specification , Engineering Standards (BPE); Construction requirements (piping slope, dead-legs); Documentation (heat and mill certificates); 
  • Appendix II =  Checklist to determine Piping Specification
  • Appendix III =  Flowchart – Introduction of New Equipment.  This provides a roadmap for both the Client and Contractor to the GMP Project steps (Design, Specification, Procurement, Testing, Commissioning and Qualification) and Documentation..

Forms included:

  • E03-5201F1  Project Piping and Equipment Material Specification Form – showing different “classes” of piping and their requirements
  • E03-5201F2  Equipment Specification Form (sometimes known as Performance Datasheet) – this is a very useful form that can be used right through from the development URS stage, procurement, construction, testing, qualification and maintenance.

Keywords:

Equipment Facility Decommissioning Asset Disposal Retirement

Who needs this template?

  • Engineering, maintenance
  • Contractors, service providers
  • Production
  • QA
  • Validation
  • QC

Associated documents and sections:

E02-21 Standards & Procedures – Design

E02-22 Standards & Procedures – Procurement & Inspection

E02-23 Standards & Procedures – Construction

E04 Operations and Maintenance