Quality control is essential when manufacturing products for the life sciences industry. Whether it’s enzymes, preservatives, biological reagents, diagnostic chemicals or medicines, every product must go through a rigorous quality control process to ensure it’s safe and effective.
As we explain below, quality control for life science chemicals covers several key areas including raw material testing, stability testing, statistical analysis, health and safety protocols, and auditing and inspection.
Continue reading to learn more about the importance of quality control in chemical manufacturing for life sciences and how it works. And if you’re looking for an experienced chemical manufacturer specialising in the life science and pharmaceuticals industry, give us a call today.
In this post:
What is life science?
Life science refers to the scientific study of how living things evolve, reproduce and function, both from a macroscopic and microscopic perspective. It includes specialist disciplines such as genetics, microbiology, biochemistry, molecular and cellular biology, physiology, botany, and zoology. It also extends to practical applications like medicine, pharmacology, genetic engineering, and agriculture.
Life sciences rely on both experimental and observational research methods. Many of the techniques and tests that are used to analyse the collected data require chemicals. For example, in microbiology, synthetic chemicals help scientists visualise microorganisms under microscopes.
Life sciences seek to understand how certain processes and conditions give rise to life. They also unpick the complexities of life’s many functions and interactions. At its simplest reductionist concept, life can be viewed as the result of highly complex, self-sustaining chemical processes contained in cells.
Scientists who are studying certain aspects of life therefore need to use specific types of chemicals in their analytical techniques – and this is where chemical manufacturers like ReAgent can help.
A breakdown of key quality control in life sciences
Quality control primarily involves testing a product to check whether it passes a certain set of standards. These standards are based on the product’s utility, along with any relevant statutory or regulatory requirements.
During the quality control process, various tests are conducted to ensure the accuracy, precision, effectiveness, stability, consistency, and safety of the product.
When it comes to life science, any chemical products that are used in this industry must pass product-specific tests. For example, a chelating agent like ethylenediaminetetraacetic acid (EDTA) needs to be effective at binding iron and calcium ions. EDTA is used in the laboratory for various biochemical processes, such as protein purification, electrophoresis, and DNA extraction. It’s also very useful for treating heavy metal toxicity.
Why do we need quality control?
Quality control is important for several reasons. Firstly, testing the worthiness of a product based on specific standards guarantees it fulfils its intended purpose or function. It also ensures the product complies with the relevant regulations and is both safe and effective. Plus, quality control often exposes faults in product samples or the production process, which then allows experts to improve their manufacturing processes and systems.
Some of the major aspects of quality control are explored below.
Raw material testing
In chemical manufacturing, raw materials are commonly used as precursors and reagents to produce other chemical products. To ensure the finished product is of high quality, these raw materials must have a high purity level.
For example, the industrial synthetic production of acetic acid requires highly pure methanol for the methanol carbonylation process. It’s perhaps unsurprising that raw material testing is therefore a fundamental part of quality control.
Chemical products intended for life sciences are only useful if they’re sufficiently stable for a certain period of time. For example, agar, which is used in microbiology to culture microorganisms, must be sufficiently stable at certain conditions for it to serve as a medium for microbial growth.
During the stability testing phase, chemical products are tested in various conditions to see if they’re affected by external changes in things like temperature, pH, and humidity. Again, stability testing is an important aspect of quality control as it enables experts to determine whether a product will continue to be effective in different environments.
Accessible research & statistics
The accessibility or repeatability of research data and statistical analysis is crucial when it comes to quality control in life sciences. Accessible research and data aren’t only necessary for peer review, but they also allow chemical manufacturers to spot trends or patterns that can help them to improve the production process and ensure the finished product is the best it can be.
Health & safeguarding
Ensuring the safety of products, laboratory set-ups, and procedures in life sciences is a fundamental aspect of quality control. It’s especially important when working with dangerous pathogens that require special safety protocols and equipment.
Find a safety management system
A safety management system (SMS) is a formalised set of rules and processes that’s designed to manage safety risks in the workplace. It encompasses physical aspects such as equipment and facilities, as well as intangible measures like methodologies and safety protocols.
An SMS applies to an entire organisation and must be followed by everyone within it. It comprises four main components:
- Safety policy and objectives
- Safety risk management
- Safety assurance
- Safety promotion
These core aspects apply to quality control in manufacturing chemicals for life sciences, although the specific elements may vary slightly depending on the product that’s being manufactured.
Inspections & audits
For manufacturing organisations, ISO standards and regulatory compliance are not a one-time deal. Periodic inspections and audits must be carried out to ensure the company is continually maintaining high quality standards. If necessary, recommendations may be made to help them improve their protocols and processes, or adapt to new regulations.
At ReAgent, we also welcome customer-led audits and will respond positively to any recommendations that arise from these visits.
Quality control is essential in chemical manufacturing for life sciences. As well as helping to ensure chemical reagents and precursors are reliable and effective, it guarantees they’re safe to use. Quality control consists of various components including raw material testing, stability testing, and inspections and audits. The exact quality control measures employed by a chemical manufacturer vary slightly depending on the specific products that are being produced.