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3 Ways to Ensure the Quality of Raw Materials in Pharmaceutical Quality Control

Person in pharmaceutical manufacturing lab

Quality control is important for any industry, but especially pharmaceuticals. Ensuring maximum quality control of raw pharmaceutical materials is one of the most basic tenets of product manufacturing in the healthcare industry. It’s crucial to have a system in place to make sure quality control is maintained from the beginning of the process onward.

However you choose to do it, effectively managing the quality of the raw materials used in health care products can help pharmaceutical products meet the necessary quality requirements. Here are three ways you can maintain quality control with raw materials.

1. Make Sure You Have the Correct Raw Materials On Hand

When choosing which raw materials to use for the manufacturing of products, there are multiple factors to consider beforehand. Firstly, you should know how much of the raw material is in stock, and if it can be replaced with another kind should there be a shortage. Secondly, you need to find out whether or not enough information and science backs up how safe the material is for consumption—for example, if there are carcinogens (cancer-causing agents) present.

Moreover, are the raw materials known for causing pharmaceutical responses, and are they compatible overall with the product? Although these are only a couple of the biggest factors to consider during the pharmaceutical quality control process, compounds have become increasingly complex and higher quantities of raw materials have been needed for some routes of production. Therefore, it’s important to make sure you have the correct ones at your disposal.

Person checking quality of pharmaceuticals
All raw materials should be the correct ones, especially in the event of a shortage

2. Do Your Research and Due Diligence on the Raw Ingredients’ Quality

One of the biggest steps of the quality control process is to ensure the materials provided by the supplier are of the best possible quality once you’ve made sure the product design is ready to go. For example, you can read up on the supplier’s reputation and history to get an idea of how reliable they are likely to be. You can also interact directly with the supplier, and test the materials beforehand for quality assurance. There should be a collaborative relationship between the supplier and manufacturer to help identify and address issues sooner if and when they arise. You’ll learn in your quality control program how to ensure the safety of materials and medicines so that you can help keep raw materials safe.

Pharmaceutical manufacturing
Changes made to the materials must be communicated between the supplier and manufacturer

3. Ensure the Pharmaceutical Quality Control’s Supply Chain Process Goes Smoothly

Lastly, this is a step where all phases of the supply chain process need to be properly looked at and fully evaluated, such as during an audit. If any changes are to be made to the process or materials, all such alterations need to be communicated between the pharmaceutical manufacturer and supplier. This can include if the material’s primary packaging has been altered, which could negatively impact the product’s quality.

Above all, a quality agreement must be reached between the parties so that the manufacturing process, source and composition of materials, distribution chain, specifications and any notifications of changes can be clearly established. This agreement will ensure that both parties understand their roles and responsibilities in regards to quality control, which helps to further guarantee the safety of a product.

Want to get your quality control diploma?

Contact the Toronto Institute of Pharmaceutical Technology to find out more.

One Reply on “3 Ways to Ensure the Quality of Raw Materials in Pharmaceutical Quality Control

  • Kindly answer this question. I’m interested to learn more about you.
    1. What is the maintenance pf quality in the process of manufacture.
    2. What is the method of quality control technique. (i.e. inspection or sampling technique)
    3. What are the types of errors in accepting or rejecting samples. (i.e. accepting bad one and rejecting good one or vice versa)
    4. What changes in the work situation might account for the increase in productivity and the decrease in controllable rejects?
    5. What were the major changes in the situation? Which changes were under the control of the manager? which were controlled by workers?

    Kindly send the answer to my gmail account.

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