When the decision is made to build a new Pharmaceutical Manufacturing Facility or retrofit an older one, value can be achieved very early on in the associated Capital Project through innovative Facility Design and engagement of the appropriate Subject Matter Experts (SME) from the beginning.
The SME group involved in the Facility Design should come from cross-functional backgrounds and their goal should be the delivery of a final Pharmaceutical Facility Design that meets the expectations of the regulatory guidelines and incorporates features to fully support the manufacturing of safe, efficacious and high-quality finished products. In addition, the design should satisfy end-user requirements and provide the appropriate conditions for personnel that will work in the facility.
The EU regulatory guidelines presented in Eudralex, Volume 4, Part 1, Chapter 3, Premises and Equipment, provide guidance on the general requirements for heating, ventilation, drains and other systems and features that are necessary for the provision of a controlled manufacturing environment that is suitable for the production of a high-quality medicinal product. The revision of this chapter in 2015 included guidance relating to the application of appropriate facility design in the prevention of cross-contamination and it states that “Cross-contamination should be prevented for all products by appropriate design and operation of manufacturing facilities”.
To get the maximum benefit from the facility design process from concept design, through detailed design and issuance of approved drawings, stage-gates should be defined in the process. These stage-gates allow the cross-functional SME group the opportunity to review, challenge and assess the design for how it will meet the needs of the end user while also providing sufficient protection to the medicinal product being manufactured.
The stage-gate reviews should challenge the facility layout and the proposed flow of people, equipment, materials, product and waste through the facility giving an opportunity to design a facility that will minimize cross-over of flows where appropriate, provide product protection and if necessary, the appropriate level of containment.
Quality Risk Management principles and tools are useful for providing a structured approach to Facility Design Review as they provide a mechanism for documentation of actions identified during the review and provide justification, based on risk, for any changes required in the design.
Innovative approaches to pharmaceutical manufacturing facility design provide the design team with an opportunity to receive cross-functional end-user feedback, identify cross-contamination risks and design weaknesses before construction has even started, thus reducing the requirement for rectifying costly errors and omissions during construction. A robust Facility Design will also reduce the risk of process deviations once the facility starts to manufacture commercial product.
PharmaLex can support your organisation in many ways. If you would like our Team to assist with the review of your Pharmaceutical Facility Design for any type of manufacturing facility, please connect with us to discuss +353 1 846 4742 or email@example.com