Gordon Leichter, PhD, Belimed Life Sciences and Jason Collins, AIA, IPS, present the benefits of the baseline guide which includes the combination of industry needs and agency requirements. “If you’re experiencing challenges with your facility currently and wondering how to either retrofit or make improvements to your facility the baseline guide is certainly a place to start,” Jason Collins said. “It’s a place to look at what you have and compare two strategies that are listed in the guide to start coming up with some practical solutions for how to either renovate or expand on what you have today.”
In writing the guidelines, there are a lot of challenges to deciding whether equipment or facilities are under designed or over designed. The guide serves to ease the burden of translating requirements for regulatory guidelines. Jason Collins said, “So many people can use the sterile manufacturing baseline guide. It can be used by facility owners, it gives a very good background for someone who’s looking to renovate or build a new facility to really get up to speed on all the main compose that are going to go into their facility.”
In providing instruction and recommendations for facility design, ISPE can make an impact in the industry and help manufacturers in ensuring sterility for their products. Gordon Leichter said, “One of the major points that the group focused on that were faced by all of us who were involved was to kind of come up with a harmonization of standards and regulations.”
In the guide, manufacturers can utilize industry standards combined with operation techniques for basic production strategies and processing that will be accepted by inspectors. The ISPE baseline guide also gives readers up-to-date interpretation of the latest FDA and EMA guidance requirements and regulations. Gordon Leichter said, “We think this guide has an excellent combination of great industry experience, we had some excellent subject matter experts involved with it from all different disciplines.” Helpful resources such as the Sterile Product Manufacturing Facility guide inspire technological advancement and allow for beneficial communication between regulators and manufacturers.