Tag Archives: CGMP

Information Technology in a Pharmaceutical Company

Supporting Rare Disease Research

The process of developing new therapies for rare diseases requires laboratories. That’s obvious, isn’t it? Another critical lab function that may not be so obvious involves quality assurance. All batches of medicines undergo rigorous testing to ensure the manufacturing process produced pure products.

Automation drives and controls medical research labs far more than your chemistry or biology lab courses did in school. Today’s automated lab instruments produce data constantly, recording moment-by-moment conditions in experiments and tests. IT Patch Panel in Rare Disease CompanyRare Disease Company IT Patch Panel

While the format of the data may result in small files, the nature of the data has led to many regulations and requirements for how the data is handled.

Data in Pharmaceutical Companies

Some kinds of data fall under strict guidelines and regulations. Anything that has to do with the manufacture of medicines and the subsequent quality control testing processes remains subject to FDA and international public health agency regulations. Violations of those regulations could actually lead to those public agencies shutting down companies in a matter of minutes. At a very high level, anything, networks and servers included, that could alter the data that would affect manufacturing or lab analysis must be validated, qualified, and controlled rigorously.

What does that mean? When a computer system becomes part of the manufacturing or laboratory environment, extensive tests certify that the application that may control a lab instrument will never invent its own data. This requirement makes sense if you think about it. Variations in data lead researchers to conclude they either have a blockbuster for treatment of a rare disease, or they don’t. If a computer system monitoring temperature of an experiment failed to record or report data for five minutes, how would anyone know if the temperature spiked and recovered, or did nothing abnormal at all?

The same concern applies to control of a manufacturing process. Manufacturing equipment may heat or cool ingredients, and most certainly measure quantities. Moment-by-moment data points assure Pharmaceutical companies and their customers the final product is the same as it has been from the first batch, and remains as safe and as effective as ever.

We all know computers require regular software updates and security-related patches. Microsoft updates usually require system reboots to take effect. Anti-virus software updates can cause a workstation to suddenly block required traffic. Normal IT procedures could have a large negative effect if updates change or disrupt the flow of data in labs or manufacturing.

“Good Manufacturing Practices” in IT in Pharmaceutical Companies

The regulations that control the manufacture of food and drug products create a set of requirements known as “good manufacturing practices” or GMP. A GMP process adheres to the stringent requirements laid out by regulatory agencies worldwide. The industry standard vernacular is “current good manufacturing processes” or CGMP.

GMP regulations or practices affect network design and the configuration management of systems involved in the manufacture or testing of medicines and foods. When a network and systems attached to it connect manufacturing or quality control lab equipment, their configurations have to be validated. Additionally, processes related to changes and maintenance have to be documented.

This complicates the “basic” tasks of network design and architecture. Many network components supporting the business side of a pharma company must change constantly to accommodate new business requirements and protect from new security threats. The two goals of enabling and protecting business operations and supporting manufacturing and disease research seem at odds with each other. However, networking professionals can take measures to satisfy requirements of both interests.

Share This: