Environmental Mapping Program (EMP)

CUSTOMER’S CHALLENGE

The organization Is a global pharmaceutical manufacturing company with multiple sites. This organization houses over 190 Environmentally Controlled Chambers (ECC’s) and Environmentally Controlled Spaces (ECS’s). These ECC’s and ECC’s require a robust Environmental Mapping Program (EMP) to ensure that they are operating as Intended and remain in compliance at all times.

HOW WE HELPED

Cheme Engineering worked collaboratively with the organization to deploy a unique, robust, and proven EMP program that fulfilled all the organization and regulatory requirements. The EMP included an In-house Data Logger Calibration Program, Periodic Review Program, Template Creation/Revision, VMP Creation/Revision, Commissioning, Qualification, Requalification programs.

 CUSTOMER’S SUCCESS

Since the project was completed, the pharmaceutical organization has seen the following improvements to their process.

• Streamlined multiple sites to follow one EMP; reducing touch and cycle times and avoiding confusion
• All ECC’s and ECS’s are in compliance and are regularly re-mapped (PQ) with the support of an ERP Software (SAP)
• A risk-based and automated approach that removed redundant tasks thus reducing time and cost
• Over 17 templates created to reduce the protocol creation time (a standard PQ protocol can be created in less than 15 minutes utilizing these templates)