Application of Regulations to Facility Design: The GMP Review

by Lorenzo Calamai Project Manager and Designer (QE) @PQE Group


Introduction and approach to the GMP Review 

One of the services provided by PQE's Quality Engineering (QE) team is the GMP review. 

The first step is to define and identify references to cGMP regulations within the facility that will be reviewed and assessed.  

Whether at the design stage or in facilities that are already in operation, the GMP Review is essential to highlight and assess any critical issues that a layout and/or facility may have in terms of compliance with the relevant regulations. 

The approach is to examine documents and drawings of the facility being reviewed and evaluated with particular attention to all GMP aspects. 

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Aspects assessed and reviewed 

The analysis concentrates, at first, on the layout of the rooms according to their intended use, assessing their correct adjacency and adequate classification (based on UNI EN ISO 14644 “Cleanrooms and associated controlled environments”); consequently, both personnel and material flows will be evaluated, trying to highlight their unidirectionality and paying particular attention to the levels of clothing and class changes (presence of adequate Personnel Airlocks and Material Airlocks) that operators and/or materials have along the production process. An important factor being reviewed is also the Heating Ventilation Air Conditioning (HVAC) system.

In fact, those parameters that are fundamental for achieving and maintaining classification within the premises depend mostly on it. A review of parameters such as air changes per hour, differential pressures and supply and return system layouts are essential to assess its efficiency and compliance with cGMP standards. In the case of existing facilities or detailed designs, architectural choices such as materials used and room finishes are also analyzed and evaluated.  These and many other aspects, if compliant, guarantee both the protection of operators' health and a quality production process. 

Characterization of observations 

The observations and gaps from the GMP Review are identified with unique codes and characterized according to their criticality in: 

  • Critical (C): an observation which has produced or leads to a significant risk of producing a product which is harmful to the human; 
  • Major (M): an observation which may lead to the manufacturing of a product which is non-compliant with its manufacturing authorization and/or which represents a significant deviation from the cGMP or any other applicable legislation; 
  • Minor (m): an observation which cannot be classified as either critical or major, but which indicates a departure from the cGMP-Part; 
  • Recommendations (R): an observation without specific reference to cGMP but which help to improve the quality system or quality of the product. 

For each observation raised during the GMP Review, a High-Level Corrective Action will be proposed to eliminate the criticality leading to the consequent improvement and adaptation of the facility to the cGMP. 


The GMP Review, if correctly performed, is an increasingly necessary and essential evaluation and review tool for our customers to achieve a production process that is cGMP compliant and as efficient as possible. 


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