Commissioning, Qualification and Validation, a GMP approach

Commissioning, Qualification and Validation Support

The focus on PTD CS’s Qualification lies in these 3 main domains: Independent monitoring system, cleanroom and HVAC.

Most important standards and regulations we use at PTD CS

Regulatory

Guidelines

Norms

Client Specific

URS

The URS or User Requirement Specification, contains specific/important requirements of an installation and/or every type of room. This is done at the start of the project.

MVP20TM

At the start of the engineering, the following qualification steps are performed:

At the end of the engineering the DQ or Design Qualification is done.
This demonstrates that the engineering documents are in accordance with the approved URS and RA, and as a result will comply with GMP Guidelines.

COM or Commissioning is the installation control and balancing of the HVAC systems by doing HVAC measurements. These measurements are executed by following commissioning protocols. 

IQ OQ PQ

We provide support to client when IQ, OQ and PQ processes are conducted.

Most important standards and regulations we use at PTD CS

Regulatory

Guidelines

Norms

Client Specific

URS

The URS or User Requirement Specification, contains specific/important requirements of an installation and/or every type of room. This is done at the start of the project.

MVP20TM

At the start of the engineering, the following qualification steps are performed:

At the end of the engineering the DQ or Design Qualification is done.
This demonstrates that the engineering documents are in accordance with the approved URS and RA, and as a result will comply with GMP Guidelines.

COM or Commissioning is the installation control and balancing of the HVAC systems by doing HVAC measurements. These measurements are executed by following commissioning protocols. 

IQ OQ PQ

We provide support to client when IQ, OQ and PQ processes are conducted.

Our clients

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