E02-00 GEP General Practices

This Sub-Category consists of good practices like Change Management, Documentation Control.

Change management is critical to GEP. Defined processes should exist to manage both project changes and operational changes.

Proposed changes to project requirements or design specifications should be assessed for potential impact on:

• PRODUCT CRITICAL QUALITY ATTRIBUTES (CQA)
• Critical Process Parameters (CPP)
• Project scope, cost, and schedule.

Critical changes shall be documented – engineering drawing to have REVISION control,

Also refer to  E02-2110 CONTROL OF ENGINEERING DRAWINGS.

NOTE:

There are 3 Change Control templates in our website. The reasons for the three SOPs are due to their applications:

• E02-0201 CHANGE CONTROL (ENGINEERING) = most engineering changes occurs during the design stages prior to manufacturing and do not affect the “Critical Quality Attributes (CQA)” of the product. The SOP follows normal Good Engineering Practices (GEP) like revision control.
• Q04-0110 CHANGE CONTROL (this template) = follows all the steps expected from Regulatory Change  Requirements – fully documented, executed and closed out.
• Q04-0111  Document Change Control Procedure = this SOP relates to changes in GMP documents.