GENESIS COSMOTECH
Why Is Pharmaceutical Quality Assurance Important?
Pharmaceutical quality assurance is one of the most critical components of the manufacturing process. But why is quality assurance important? Quality standards ensure public safety and help pharmaceutical companies avoid substantial penalties from industry regulators.
Continue reading to learn how mastering quality assurance in the pharmaceutical industry helps achieve regulatory compliance and increase your ability to manufacture high-quality medicines.
What Is Quality Assurance in the Pharmaceutical Industry
In order to ensure the effectiveness and safety of drug products, every country has regulatory agencies that regularly review and inspect the pharma industry’s manufacturing sites.
Pharma Quality Assurance (QA) covers all aspects of the pharma industry that can impact the quality of products. From the procurement of raw materials to manufacturing, the entire process is constantly monitored and updated to ensure consistency and compliance. Pharma QA also includes maintaining the quality of the finished products through appropriate storage at the manufacturing facility, distributing medications correctly, monitoring environmental conditions and more.
Corporate Regulatory Compliance and Quality Assurance
In order to have patients and healthcare professionals use our products with peace of mind, complying with the Act on Securing Quality, Efficacy and Safety of our products.
Genesis Cosmotech, makes efforts to maintain and enhance the corporate regulatory compliance and quality assurance system by auditing work procedures in research, development, production and post-marketing activities to ensure reliability.
Also, through collecting and centrally managing information obtained from healthcare professionals and preventing problems through providing information on proper use, we are proactive in predictive and preventive activities.
Prompt Inquiry-response with Our Quality Information System
When an inquiry raised in the system, we begin investigating immediately, checking retained samples from the same lot, verifying manufacturing records and confirming the quality of the product in question. The root cause of the quality issue is also investigated, and when necessary, the QA team plans and implements actions to prevent recurrence. This has made it possible for us to provide faster responses to inquiries.
Objectives of Pharmaceutical Quality Assurance
Below are the primary objectives that every pharma quality assurance program must strive to meet.
Ensure Product Quality & Safety
A pharmaceutical company’s primary goal is to make medication that works. However, if a sound pharmaceutical quality assurance system is not in place, the pharmaceutical products that are intended to save lives can instead cause irreversible harm or even death. The pharmaceutical industry, and every employee involved in pharmaceutical quality assurance, should always maintain focus on the people taking the medications and the potential impact on their health.
Avoid Negative Publicity
A robust pharmaceutical quality assurance system ensures that products are effective and safe. Following good manufacturing practices (GMP) and enacting comprehensive inspection policies help drug manufacturers produce the highest quality products and avoid reputation-damaging incidents. Pharma quality assurance protects against negative publicity.
Improve Efficiency
Pharmaceutical quality assurance is primarily about producing reliable and safe products. The second aspect of pharma quality assurance is that it promotes continuous improvement, from technology transfer to product development.
Advanced technologies allow for tighter controls and closer monitoring of the pharmaceutical manufacturing process. Automation and virtual processes increase productivity and safety, but product quality must never be compromised.
Guarantee Compliance
Regulations are constantly changing, so keeping up-to-date with pharma industry standards requires an effective pharmaceutical quality assurance system that includes solid processes and risk management procedures to address regulatory compliance.
Many compliance issues that the pharmaceutical industry faces are not due to intentional wrongdoing. Instead, these costly errors can most often be attributed to poor workflows, human error or sloppy record-keeping.
Even if you are in 100% compliance with pharmaceutical quality assurance requirements, you may still be fined if you don’t have the records to back you up. Documentation of your quality systems will help prove that you meet regulatory compliance requirements.
How Our In-House QA Adds Value to Our Clients and Partners
Our in-house QA department directly benefits our PCD pharma franchise partners, third-party manufacturing clients, and institutional buyers by offering complete transparency and documentation. Clients receive batch-wise quality reports, certificates of analysis, and assurance that each product has passed multiple internal checkpoints. With this internal quality system in place, we can assure faster product approvals, quicker market launches, and ultimately, a stronger brand reputation. For franchise partners especially, this adds tremendous value — helping them win trust among doctors and end-users while supporting business growth with zero compromise on product integrity.v
GENESIS COSMOTECH