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The Need For An Effective Inspection System In Pharmaceuticals

By Author: Ora Wilcox
Total Articles: 2

In any factory that mass produces a single product, there is usually an errant, defective product that comes out of the manufacturing line. For instance, a factory that makes toy robots occasionally encounters one particular robot with a missing arm or leg. Dealing with such a product is quite easy since it can either be scrapped or sold with a huge discount as belonging to damaged goods.

However, the same can't be said when it comes to pharmaceuticals because identifying a “defective” (i.e. poorly formulated) pill or tablet is quite impossible by using the basic human senses alone. This is the reason why an automated or semi-automated inspection system must always be employed for quality control (QC) when making pharmaceuticals. Identifying defects in prescription medicine involves looking at various factors—more complex than just watching out for missing robot parts.

Sterility

Much like food containers, medicine containers must be free from microbes (especially bacteria) that can contaminate the products stored in them. Arguably, sterility tests are especially important to parenteral drugs (those that are intended to be injected through the skin) since harmful contaminants can cause damage faster when they're in the bloodstream. Some inspection machines run these tests on the drugs during and after production.

Consistency

Another reason why a reliable inspection system is needed in the QC of pharmaceuticals is that it ensures consistency in formulation. Even the slightest miscalculation can lead to reduced effectiveness of the drug or unintended side-effects in the patient. Consistency is very important in medical syrups since they are more vulnerable (i.e. accidentally shaking them during production).

Quality

While obviously the main point of QC, quality also includes adhering to the manufacturing companies' production standards. Aside from the two aforementioned points, products must also be tested for more mundane things. Much like a defective toy, a cracked medicine bottle or an unsealed medical tablet are already compromised and must therefore be disposed.

One may argue that these three points are not at all different when it comes to producing other things like toys. That may be true, but inspecting pills, tablets, and syrups requires more than just watching out for physical defects. To learn more about inspecting pharmaceutical products, visit fda.gov/downloads/Drugs/Guidances/ucm073517.pdf and americanpharmaceuticalreview.com/Featured-Articles/126885-The-Importance-of-Quality-Control-in-the-Production-of-Parenteral-Drugs/.

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