E00-0101 Policy Statement – Good Engineering Practice

$60.00

The purpose of this Policy Statement::

  1. to state the Company’s philosophy and commitment to implement GEP.
  2. to define the importance of GEP in the execution of engineering activities or projects.
  3. it includes a flowchart to help you plan/implement
SKU: E00-0101 Category:

Description

GEP Flowchart (jpg)

GEP Flowchart (jpg)

What is this process and document about?

  • The biotech and pharmaceutical industry are looking for a whole range of process improvements to reduce the time and cost to build and validate facilities. One of the good practices that the industry, institutions and regulatory authorities are encouraging is Good Engineering Practice.
  • Good Engineering Practice (GEP) is established methods and standards that can be applied throughout an engineering activity, project/equipment life-cycle to ensure delivery of appropriate and cost effective solutions.
  • For Facility & Equipment, more emphasis is now placed on “quality at source” that is, driving “Quality” at grass roots engineering practices. A disciplined engineering system will provide a solid foundation to the whole process of producing quality products and meeting regulatory compliance.
  • GEP is one of the core concepts to streamline the Validation process – as explained in ASTM-E2500.

This document has 2 parts

  •  Part 1 – describes the rationale of why this procedure or standard is required, cross reference relevant regulatory clauses
  • Part 2 – the document template

Attachment

 Good Engineering Practice (GEP) process map (flowchart) in MS Visio to guide you

 

Associated Industry/regulatory guidance and requirements:

  • ISPE Good Practice Guide: Good Engineering Practice.
  • ASTM E2500-7 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing System and Equipment.

Who needs this document?

Project Engineers and Managers, Maintenance, Validation Engineers, Vendors and Contractors.

Related Documents or Topics:

Q00-00-01   Quality Management System
E01-01-01   Risk Management (FEMCA)
E02            Common Practices & Systems
E03            Project Engineering & Management
E04            Operations & Maintenance

View sample pages (opens in Adobe pdf)