: In order to stay within regulatory guidelines, what are some must-have technologies that a pharmaceutical company should implement to meet microbial monitoring requirements?
DJ: The core regulatory guidelines for microbial monitoring have not changed dramatically in recent years, but the guidance documents around these guidelines have become more explicit in calling out the risk of manual observations. The guidelines call for a risk based approach to contemporaneous secondary verification and have suggested that computer interface and automated technology is one way to reduce the risk associated with human observations.
: If a pharmaceutical company is looking to upgrade its microbial monitoring and testing processes, are there some relatively easy, first steps to take? What do you recommend and why?
DJ: If a pharmaceutical company is looking to upgrade its microbial monitoring and testing processes the first thing they should do is move to an automated alert system. Too many facilities receive 483s because they didn’t act on results that exceeded their own action and alert specifications. Companies can automate the review of their data by installing an environmental monitoring software package to facilitate rapid and frequent review. Inclusion of automated microbial detection systems and direct communication to the software facilitates better data security as well as better control.
: Do you foresee pharmaceutical companies implementing the strict microbial monitoring strategies used for sterile product production on other types of products – such as solid dosage?
DJ: Yes, we do see the FDA suggesting more routine environmental monitoring for all types of manufacturing. Frequent environmental testing and monitoring is an important tool for demonstrating that a facility is in control.
: What are some best practices a pharmaceutical company should put in place to collect, store and analyze microbial monitoring data?
DJ: Moving away from paper is an important first element in collecting, storing and analyzing the large amounts of data that is being produced in manufacturing facilities. The next step is to automate the analysis of this data in a secure database that has a full forensic audit trail. The third best practice is to learn from this data and use it to improve the manufacturing and cleaning processes.
: In the near future do you see pharmaceutical companies moving away from large cleanrooms to processing sterile products in isolators, gloveboxes or RABS? If so, why?
DJ: Yes, in an effort to reduce the risk of human contamination the introduction of robotic manufacture in RABS or other isolation systems will become more common. Many companies are already investigating the options in this field and as the these become commercially available companies will transition their processes to these kind of manufacturing environments.