Commissioning, Qualification and Validation, a GMP approach

Most important standards and regulations we use at CRC Engineering

Regulatory

• Eudralex Volume 4
• Koninklijk Besluit (KB)
• 21 CFR Part 11
• GAMP 5

Guidelines

• Pharmaceutical inspection convention (PIC)
• ISPE guidelines
• EU-GMP-Guidelines
• FDA guidelines

Norms

• ISO 14644
• ISO 14698
• EN 1822
• EN 12599
• VDI 2083

Client Specific

• Internal procedures
• SOPs

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.

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

• MVP or Master Validation Plan, defines all measures needed to perform a successful qualification, relevant scopes, boundaries, tasks roles,...for the qualification
   
• RA or Risk Analysis, is the detection of potential GMP-risks. 
   
• TM or Traceability Matrix, is used to assist in determining the completeness of a relationship between documents and is also used when there are high-level and detailed requirements.

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 or Installation Qualification is the verification of the installed static & physical components of the system. It is also a check to see if it reflects the as-built situation and if the risk aspects on design and construction have been covered.
   
• OQ or Operational Qualification provides that the environmental GMP conditions are met when HVAC is running.
   
• PQ or Performance Qualification provides that the environmental GMP conditions are met when production is ongoing.