This Standard Operating Procedure (SOP) provides guidance to the development, management, classification and control of engineering drawings. This SOP has been adopted in many ‘big name’ facilities.


What is this process and document about?

  •  This Standard Operating Procedure (SOP) provides guidance to the development, management and control of engineering drawings throughout its life-cycle.
  • This document has 2 parts:
    • Part 1 (4 pages) – describes the rationale of why this procedure or standard is required. The Good Engineering Practice flowchart shows the “big picture” of the role of Control of Drawings in good practice.
    • Part 2 (15 pages) – the document template and two forms.
  • The drawing control process begins with a methodical numbering and classifying (quality & safety impact) of the drawing, the application of Change Control, Maintenance requirements and finally the Life cycle of the drawing.
  • This “grass roots” process is fundamental and the foundation to Good Engineering Practice, GMP, Validation and compliance to ensure the correct and “quality-impact” drawings and design is fit for “intended use” to produce quality products.
  • Forms included:
    • Drawing Classification Form takes you through a series of questions and answer to determine the impact of the drawing to GMP, Quality and Safety
    • Drawing Register Template (MS Excel)
  • Included Sections in Template:
    • Purpose, Scope, Training, References and Associated Documents, Definitions/Acronyms, Responsibility, Procedures, Appendices and Attachments.


Industry/regulatory guidance and requirements:

  • FDA (US) Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, August 2001), Sections 5.1.
  • PIC/S PE 009-8 2009 Guide GMP Medicinal Products – Part 1: 3.42, 4.5
  • ASTM E2500-7 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing System and Equipment; Clause
  • ISPE Good Practice Guide: Good Engineering Practice


Who will benefit from this document?

  • Engineering department
  • Quality Control
  • Manufacturing
  • Engineering Vendors and Contractors


Good Engineering Practice GEP Control of Engineering Drawings Drawing Register Classification GMP Drawing Equipment Control


Other related Design processes and documents are in E03 Project Engineering

Some typical design document in GMP Projects

E03-50-00 Project Quality Sys Flowchart – Design

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