As the world continues to grapple with COVID’s new variants, along with RSV (respiratory syncytial virus) and seasonal influenza, the pharmaceutical industry remains fully in the spotlight.
A report published in the Journal of the American Medical Association stated that public distrust in the pharmaceutical industry has increased due in part to the perception of pharmaceutical manufacturers as focused on profits.
A recent Gallup poll revealed that public trust in the pharmaceutical industry slipped to its lowest level since the annual survey began in 2001.
Industry experts maintain that a robust focus on quality management is the key to regaining public trust.
“Quality management is important in every business, but it is critical to the pharmaceutical industry,” says Manish Malik, Quality Manager, External Manufacturing, for RB Health Manufacturing LLC, in Salt Lake City, Utah. “To put it bluntly, poor quality of drugs or medical equipment puts lives at risk.”
Malik, who holds a Master of Science degree in Organic Chemistry from CCSU Campus Meerut and has spent 13 years focusing on quality management and compliance in pharmaceutical operations, maintains that Quality Management Systems (QMS) are the backbone of the pharmaceutical industry.
With today’s complex global supply chains and increasing demand for medicines, quality control is more urgent than ever before. A lack of QMS in the pharmaceutical industry can have serious ramifications for patients, the industry, and society.
QMS involves the standards and procedures that help ensure that products meet all regulatory requirements regarding safety, reliability, and effectiveness.
Regulatory bodies such as the Food and Drug Administration (FDA) and the World Health Organization (WHO) establish and enforce legal standards and regulations to ensure that pharmaceutical companies adhere to strict standards throughout the entire testing, manufacturing, and distributing process of medicines.
The key regulations maintained by these agencies that affect the pharmaceutical industry include:
- Good Manufacturing Practices (GMP)
- Good Laboratory Practices (GLP)
- Good Distribution Practices (GDP)
- Good Clinical Practices (GCP)
Here are seven ways QMS assures these regulations and guidelines are met or exceeded by a pharmaceutical company.
1.) Enhanced control. An effective quality management system begins with the selection of raw materials. With strict QMS in place, a pharmaceutical company starts from scratch with the best and safest of ingredients.
2.) Better product assessment. Following QMS with rigor means that all research and development and product testing are held to the highest standards for safety and efficacy.
3.) Increased accuracy. QMS in the pharmaceutical industry includes drug sampling, testing, analysis, and data reporting. Software systems can ensure the proper dosage is prepared for all medicines.
4.) Supply chain management. QMS also involves supplier management, including evaluating materials, quality, pricing, and timely delivery.
5.) Production management. Packaging and labeling are an essential part of QMS for the pharmaceutical industry. QMS helps oversee production investigation, looking for any errors or defects that could potentially affect the safety or efficacy of the product.
6.) Improved efficiency. QMS also identifies areas where the company can reduce waste or streamline processes, helping the company to work smarter and better while maintaining the highest of standards.
7.) Collaboration. Consistent collaboration between regulatory agencies, healthcare providers, and industry stakeholders is another critical component of QMS in the pharmaceutical sector. By working together to share best practices, set and meet standards, and address challenges, these groups can help ensure the safety and efficacy of medicines.
“Consumers want products they can trust and companies that are responsive to their needs,” Malik says. “They will turn away from companies that experience negative press or have product recalls.”
“In such a competitive industry, maintaining consumer trust and loyalty is paramount. QMS helps build and maintain that trust.”
However, Malik is quick to point out that establishing QMS is more than just a one-and-done task. Pharmaceutical companies must regularly review their processes, identify areas for improvement, and implement changes when needed. The pharmaceutical industry is continually evolving, and quality standards must keep up to date with those changes.
“Patients rely on safe and effective medicines to maintain or improve their health,” Malik concludes. “Everyone benefits when the industry prioritizes quality control at every stage.”
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Written by Linda Stevens
Brought to you by Atif Sharif
Photo: iStock
The post Quality Management Systems: The Backbone of Pharmaceutical Manufacturing appeared first on The Good Men Project.
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