OREANDA-NEWS. September 15, 2015. Pharmaceutical products must be produced with perfection in mind. The slightest deviation from any production specification can quickly jeopardize the health and lives of human beings. So it’s no wonder that regulatory authorities like the United States Food and Drug Administration (FDA) and its European counterpart, the European Medicines Agency (EMA), keep a very sharp eye on manufacturers. Pharmaceutical companies must therefore document in painstaking detail that they have followed all regulations, from raw materials and how they are processed all the way to product storage and transport.

In practice, this means that multiple staff members must monitor production – inspecting, recording, and extensively documenting all process steps. This “batch record” is a kind of biography of the batch and can fill up to 500 paper pages, depending on the medication – so it contains a whole lot of information. “In simplified terms, pharmaceutical production is like baking a cake,” explains Andrew Whytock of Siemens Vertical Sales Pharma. “Every medication has its own recipe that lists the ingredients and production steps down to the last detail – except that, unlike in the kitchen, each recipe is as long as several cookbooks.”

This recipe includes not only the properties of precursor materials but also the subtleties of how they are processed – the quantities, the ambient conditions, and exactly how they have to be mixed or fermented. “Employees always have to study the detailed specifications in the batch record and then sign their names to confirm that everything was carried out within the specified parameters,” notes Whytock. “That makes it possible down the road to check which employee used which machine to weigh the precursors, for example. This information allows the authorities to track the exact path a batch took during production, should that become necessary.”