Company leaders must prioritise pharmaceutical quality assurance to stay competitive and keep their profits growing, regardless of which parts of the world they serve and how many customers they have. This ensures patient safety and solidifies a business’s reputation in a competitive marketplace. Here are some of the reasons attention to quality assurance is essential for success in today’s market.
By Emily Newton
Ensure Effectiveness
A quality control commitment significantly increases the likelihood of pharmaceutical products working as expected. That’s vital since people rely on them to manage chronic illnesses, treat sickness and improve their overall quality of life.
Pharmaceutical factories that don’t focus on quality control for every step of the production process could create less effective products that don’t work as consistently. That’s even true for the excipients, which make the active pharmaceutical ingredients work correctly.
Although an excipient does not directly relieve someone’s symptoms, it impacts how well the active ingredients work. For example, it affects the drug’s stability and how soon it’s released into a patient’s bloodstream.
However, low-quality excipients could lead to a medication not providing relief to a patient ending up in the hospital because of exposure to toxic substances. Quality issues with excipients can even have ripple effects by minimising how well the active pharmaceutical ingredients work.
The whole business could be affected, whether the pharmaceutical quality assurance shortcomings affect excipients, active pharmaceutical ingredients or both. Formerly loyal customers may begin buying other products they believe will be more effective or safe. Companies may need to deal with regulatory scrutiny or recalls in more severe cases.
Improve Supply Chain Management
The pharmaceutical supply chain has a tremendous reach, and people must take quality-centric approaches to keep it running smoothly. That might mean you only work with suppliers with a demonstrated history of high-quality products and on-time deliveries. It could also involve tracking shipments with connected sensors as the goods move over land and sea to their destinations.
It is vital to understand what happens to pharmaceuticals as they move through the supply chain. Many products remain safe and effective if shipping company personnel keep them in temperature-controlled conditions. Pharmaceutical company representatives who see real-time data about unexpected temperature changes could contact shippers to see if something’s wrong. Catching the problem nearly immediately is an excellent loss prevention method.
Keeping quality levels high also means managing the supply chain to limit catastrophic outcomes. Which medications — if suddenly unavailable in large parts of the world — would most threaten the well-being of people who depend on them? Which inactive ingredients are used in the most products and are particularly important to keep in stock?
Consider how over 30,000 oral solid dosage drugs contain magnesium stearate as an inactive ingredient. Since it does not have suitable substitutes, a shortage could affect millions of patients worldwide.
Decision-makers must also remember that supplier issues of any kind or duration could ultimately affect all companies that depend on those parties. A critical part of pharmaceutical quality assurance involves thoroughly vetting all supply partners and holding them to clear minimum standards.
Keep Assets Well-Maintained
Pharmaceutical plants contain a wide range of specialised equipment crucial for successful and consistent manufacturing processes. Agitators mix liquids to promote chemical reactions, centrifuges separate liquids from solids and tablet presses form oral medications into the desired shapes. Packaging equipment puts products into blister packs, bottles, cartons or tubes.
Establishing a new pharmaceutical plant is a substantial investment. However, people must also put money aside for the continual upkeep of assets. The industry uses storage vessels that tolerate temperatures from 120 to -70 degrees Celsius and help companies maintain hygienic conditions. However, periodic inspections are needed to check for corrosion, which could shut down operations if not found in time.
Many pharmaceutical leaders use sensors and algorithms to build predictive maintenance strategies so they become aware of problems long before failures occur. Besides increasing equipment visibility, this approach improves the deployment and productivity of maintenance professionals.
The alternative is that equipment may perform abnormally for days or weeks before people notice something’s amiss and take action. That lack of oversight erodes pharmaceutical quality assurance through a lack of visibility. Poor equipment maintenance could also cause plants to fail inspections, and manufacturers may receive orders to stop producing some or all products until they get back in compliance and pass future checks.
Maintain Patient Safety
Failing to uphold quality assurance standards in a pharmaceutical plant could put patients at risk and cause the offending parties to receive worldwide attention. Consider a tragedy a few years ago where 12 children in a northern region of India died and four others became severely disabled. An investigation revealed cough syrup as the cause.
Samples taken from manufacturer Digital Vision Pharma showed a 34% concentration of the toxin diethylene glycol. However, the internationally accepted safe limit is just 0.10%. Company leaders asserted their medicines did not contain it or cause the patient complications. However, they did not give evidence to support those claims.
Companies that take pharmaceutical quality assurance seriously should have the information to show that product abnormalities have not occurred. They’ll also likely have ongoing internal data analysis initiatives that spotlight potential issues before products leave the factory.
Product recalls or other safety issues could permanently damage a company’s reputation and make it lose ground in a competitive marketplace. That’s why it’s best to take precautions to prevent such problems. Scheduling periodic training sessions is a practical way to ensure people have the most up-to-date knowledge, even as new hires arrive.
Pharmaceutical Quality Assurance Matters
A well-developed and current quality assurance plan for a pharmaceutical company will help the business avoid pitfalls and gain patient trust. It can also make unwanted scenarios less common, such as supply chain shortages and equipment failures. These situations can be extremely costly and limit productivity. Even though quality assurance frameworks take time and effort to create, they pay off in the long run by minimising the chances of significant business disruptions or patient health threats.
Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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