The International Society for Pharmaceutical Engineering (ISPE) issued a guidance document in September 2012 aimed at establishing a baseline for the design of quality laboratory facilities. The ISPE Good Practice Guide: Quality Laboratory Facilities provides step-by-step considerations for producing a quality pharmaceutical-product laboratory. Here, ISPE President Nancy Berg talks about the guide.
BioPharm: What were the primary goals in issuing a guide on this topic? In other words, what regulatory challenges and technology/engineering gaps were facing the bio/pharmaceutical industry that needed to be addressed?
Berg: One of ISPE's overall goals is to help the industry create common points of reference and common language, so that all levels and job functions can work together more easily to address and solve technical challenges. In the quality laboratory space, we identified that quality laboratory owners and engineers needed a tool to help define the requirements for renovating existing laboratories and/or developing new laboratory facilities. That was the primary goal of the ISPE Good Practice Guide: Quality Laboratory Facilities, which presents design guidelines focused on pharmaceutical quality laboratories within or part of a GxP regulated environment.Using the guide will help eliminate the engineering gaps created by an engineering team moving ahead without a properly defined scope of work. The guide addresses concerns such as defining the requirements of the laboratory and finally performing the risk assessment with the entire team prior to detail design. By focusing on the client to define the requirements, this guide is useful to both the owner and the architect/engineer. Our aim is that firms will use this guide as a path forward for their clients to help define the deliverables and eliminate uncertainty.
BioPharm: The guide provides the industry with specific recommendations for meeting GMP requirements of global regulations such as 21 CFR 210–211, the International Conference on Harmonization Q7 guideline on GMP for APIs, the European Union GMP Guide, and other cGMPs. Performing a risk assessment is a key theme across these requirements, and the ISPE guide describes how to apply such an assessment to a quality laboratory facility.
BioPharm: Can you offer some key takeaways from the guide in this area in terms of what the industry must consider that perhaps they have not considered in the past with regard to risk?
Berg: The guide provides much needed guidance on how to apply a risk assessment to a quality laboratory facility and identifies issues to be considered when conducting the risk assessment. Basically, it tailors many of the same risk concepts described in ICH Q9 to this type of facility. For example, a risk assessment may reveal that a laboratory space is insufficient for the planned storage or staging of samples and reagents for testing. Of course, this type of deficiency may lead to several problems, including a mix-up of the samples or reagents.
The risk assessment allows the client to consider the requirements needed to meet regulations. All too often, the architect and engineering support team delivers a technically elaborate facility that is far beyond the need of the owner to support the testing. The owner is then strapped with ongoing calibration and validation that is not needed for the testing protocols. On the other hand, if the guide is used to its fullest, the laboratory owner can define those areas needed that are technically elaborate.