If you've been reading about ERP systems for medical devices or ERP systems in the pharma industry, you know that quality control regulations have grown more stringent over the last few years. These changes require companies to implement life science ERP software to centralize, streamline, and optimize their processes. But what exactly are the steps of quality control in the pharmaceutical industry?
Why Is Quality Control Important in the Pharmaceutical Industry?
Drugs are critical to human health and well-being, so their quality is critical. When dealing with consumable products that people rely on, poor quality control measures can lead to devastating consequences.
One of the most notable examples is the 2008 Chinese melamine milk scandal, in which many infants were hospitalized due to kidney damage after consuming infant formula that had been adulterated with melamine. While that particular incident didn't take place in the pharmaceutical industry, it does underscore the importance of quality control in any industry where products have the potential to cause harm.
In the case of pharmaceuticals, there are a few reasons why quality control is so important:
- To ensure patient safety—obviously, the primary concern in the pharmaceutical industry is patient safety. All drugs must meet certain safety standards before they can be approved for use, and it's the job of quality control to make sure those standards are met.
- To comply with regulations—the pharmaceutical industry is one of the most heavily regulated industries in the world. Quality control is essential for ensuring compliance with all regulations, both in the country of manufacture and in the countries where the drugs will be sold.
- To protect the company's reputation—in an industry where public trust is so important, a company's reputation can be easily tarnished by even a single quality control lapse. This is why pharma companies go to great lengths to ensure that their products meet the highest possible standards.
What Are the Steps of Quality Control in the Pharmaceutical Industry?
Now that we've answered the question of why quality control is important in the pharmaceutical industry, let's take a look at the steps that are typically involved in the process.
- Raw materials testing—the first step in quality control is to test the raw materials that will be used to make the drug. This is important for two reasons—to ensure that the materials meet the necessary quality standards, and to verify that they haven't been contaminated in any way.
- In-process testing—once the raw materials have been approved, they are sent to the production floor where they are transformed into the finished product. In-process testing is conducted at various stages of production to ensure that the drug meets all quality specifications.
- Final product testing—the last step in quality control is to test the finished product to confirm that it meets all the required standards. Only products that pass this final testing stage are released for sale.
These are the three main steps that are involved in quality control in the pharmaceutical industry. Of course, there are many other sub-steps and procedures that are carried out at each stage, but these are the three main ones.
Quality control is essential in the pharmaceutical industry to ensure patient safety, compliance with regulations, and to protect the reputation of the company. After testing raw materials, in-process products, and finished products, only products of the highest quality are released for sale.