At the close of the fourth season of the award-winning television drama Breaking Bad, Walter’s rival Gus loses his methamphetamine laboratory to human error. Perhaps if he had installed and been utilizing an automated environmental monitoring system, the total loss could have been prevented.
While such poor operational practices may be acceptable within the world of illegal narcotics production, distribution and, well, retribution, if a legally licensed pharmaceutical company were found liable for such gross oversight, as accidental as it might be, the firm, through the Good Manufacturing Practices Code of Federal Regulations, could be held accountable by the FDA.
The GMP standard for production, processing, packing and distribution of pharmaceutical drugs is covered with in 21 CFR Parts 210 and 211, and while each part has several subsections, some selected highlights are the following:
- The design, operation and maintenance of buildings and facilities
- The storage, testing and use of components, containers and closures
- The packaging, labeling, holding and distribution of drugs
- The collection and authentication of laboratory, production, distribution and complaint records and reports
A great difference between the organizations portrayed on Breaking Bad and those involved in real-life pharmaceutical production is that while the former entities lack any regard for the rule of law, let alone adherence to GMPs, the latter ones must comply with them daily or incur penalties. However, one uncontrollable commonality of both industries is human error, and gaps in GMP requirements like environmental monitoring can cost a pharmaceutical manufacturer time, money and credibility.
For example, building and facility regulations include specifics on the installation and maintenance of adequate lighting, sufficient plumbing for potable water, safe and effective sewage disposal and efficient ventilation, filtration and heating and cooling systems. Additionally, holding and distribution guidelines require that all warehouses and transport vehicles comply with GMP details similar to those just noted.
In order to prevent drug contamination, all areas must be monitored by a system that pays special attention to air quality and temperature and humidity levels. This system must also be capable of recording and retaining such information so that federal inspectors can confirm GMP compliance. With so many assets at the mercy of unpredictable natural elements, shouldn’t the responsibility of accurate and consistent environmental monitoring be delegated to an automated, cloud-based system?
The storylines of Breaking Bad are brimful with personal and organizational disasters, and many of these are attributable to human error. Pharmaceutical companies following GMP have the opportunity to break the trend of unreliable data collection and storage by allowing Temperature@lert’s Cellular Edition and its complementary Sensor Cloud to carry the responsibility of process compliance and product protection.