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Quality Control In Biotechnology

Before we head into the specifics we need to know what Quality Control (QC) is. So Quality Control is to check the Quality of an item in production to make sure it is under the set standards and procedures. Meaning it meets the requirements of the client or customer. We can say that QC is similar to quality assurance. Quality Control In Biotechnology?

Next, we need to know what Biotechnology is!? In simple words Bio comes from Biology and Technology is well technology. After the word breakdown, now let’s go to what it means… It is a technology that utilizes biological systems, living organisms, or parts of this to develop or create different products biotechnology harnesses cellular and bio-molecular processes to develop technologies such as genetically modified foods.

Quality Control In Biotechnology

Quality Control In Biotechnology

There are different procedures in the Quality Control of Biotech (Biotechnology in short) products Quality control is results-oriented hence procedures are followed to identify faults in the finished product. These procedures are as follows:

  1. Batch inspection
  2. Sampling
  3. Validation
  4. Laboratory testing
  5. Software testing

Biotechnology is regulated by the rightful regulatory authority, such as the FDA or Food and Drug Authority in the United States. Such authorities document every step and procedure otherwise if it isn’t documented, a startup might find out that they need to do all the work that has to be repeated to be valid in the eyes of the FDA.

Quality Control In Biotechnology

To achieve the Quality they want, the organization has to invest in Quality Management systems to facilitate accurate, timely secure record keeping. Time stamps with all the entries, alongside policies that require scientists to enter information within a time frame after an experiment is done. Though these Quality Management systems are expensive having to perform repeated experiments, in comparison, can be more costly.

So for such instance, my company needs to proceed with a document that includes the following items:

  • Management needs to buy a system for Quality Control and make sure the team adheres to that system because No quality system can function correctly without employee training and accountability
  • Planning an oversight on how, what, and when to communicate the objectives to the resources available. The company should plan out oversight of how quality programs are established and communicated to all employees.
  • How to Maintain and Manage the Quality Management resources and their application by the employees
  • Clearly defining the Quality Policies that describe the Quality Strategy to achieve compliance
  • Review the Quality system periodically for its effectiveness since things change as time progresses.
  • Communication with the vendors and service providers so any changes are accounted for

Biotech quality control

Quality Control is a set of activities that help detect defects and quality issues before the products reach the hands of end customers. It is very important for Biotech companies to Quality control their products to ensure that they deliver high-quality products and the organization runs on a Quality Management system that is approved by the FDA or such authorities depending on the country they live in.


Biotechnology’s quality control can leverage minimal testing through source code review and addressing known issues to minimize defects and meet standards. Testing remains crucial for quality control, yet not singular. A holistic approach blending meticulous source scrutiny, issue mitigation, and comprehensive testing best ensure optimal quality standards within the organization’s framework.

Quality control stands as a paramount factor in guaranteeing bug-free applications aligned with specifications. However, it’s crucial to note that while QC is vital, it might not always epitomize the pinnacle of efficiency in ensuring quality

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