LinkedIn

NE 185 is newly published

from 2022-08-19

The NAMUR Recommendation NE 185 has been released and may now be obtained from the NAMUR Office.

Abstract to NE 185 "Requirements for the qualification of the PCT of modular plants in the GMP environment"

The NAMUR working group 2.4.1 "Process Orchestration" has merged with the working group 2.3.1 "Batch Control" in 2019. This was done with the aim of jointly surveying the requirements for MTP and Process Orchestration and continuing previous work for MTP and Modular Production.

In several subgroups, this working group addressed "POL Functional Requirements for MOM (Manufacturing Operations Management) and Process Control," "Plug and Unplug Requirements of Process Equipment Assemblies (PEA)," "Technical and Communication Integration and Data Modeling Aspects," and "Definition of Validation Scope Derived from Operational Requirements in Regulated Industry for Modular Production."

NE 185 is intended to provide pharmaceutical manufacturers of modular production facilities and PEA suppliers in the regulated GMP environment with an implementation recommendation to qualify modular production facilities in the regulated GMP environment and to maintain the qualification status over the life cycle of the production facility.


« Back
loading...