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.
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How Is Pharma Quality Assurance Ascertained?
The importance of quality assurance can not be overstated, so it's imperative that quality be verified through testing. Quality assurance in the pharmaceutical industry includes:
- Lab testing to ensure that pharmacopoeial standards are met.
- Shipment inspections that involve both a visual examination of the product and a review of specifications, including expiration dates.
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.
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How To Meet Pharmaceutical Quality Assurance Goals
Strict quality control is required to meet these objectives, including:
- Employee training
- Continuous improvement of quality management systems
- Minimizing or eliminating deviation
- Documentation
- Internal audits
- Management reviews
Why Is Quality Assurance Important?
Pharma QA and a sound quality assurance department are the backbones of the pharmaceutical business. They allow companies to guarantee that their products conform to applicable quality, drug stability and safety standards. In addition, they ensure that a company avoids non-compliance of regulatory requirements.
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UPM Is Your Pharmaceutical Quality Assurance Expert
When you partner with UPM, you can be confident that our team will successfully manage pharmaceutical quality assurance and compliance for your complete manufacturing process — from tech transfer and clinical trials to warehousing and everything in between. We understand the importance of quality assurance and work on your behalf to ensure compliance.
Our pharmaceutical quality assurance system is designed to meet your specific development and manufacturing needs at any scale. You can rely on UPM's award-winning expertise for all your pharma quality assurance and manufacturing needs.
To learn more about how our family-owned, US-based CDMO can help you achieve quality pharmaceutical production, call us at (423) 989-8000.
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