Partner and VP Sales Global and Head of Subsidiaries at PQE Group.
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Although there is a wide range of important aspects to consider when working in the pharmaceutical industry, one of the most crucial objectives is to create effective and safe medications for patients. To do this, companies must ensure they maintain compliance by following strict guidelines and adhering to a quality management system in the process. Quality management systems (QMS) can provide essential tools for any company. Not only can they help reduce costs, but they can also increase profits by helping enterprises reduce waste while increasing organizational effectiveness.
One goal of QMS and pharmaceutical companies is to continuously improve operations by enabling faster speeds and fewer errors. It is key to measure and monitor the attainment of these objectives as well. Leveraging a strong QMS can allow businesses to evaluate their processes, policies and procedures to develop a proper risk analysis and best position themselves for sustainable success.
A strong QMS solution should ensure access to an experienced and trained team, which is integral to any firm’s success. Employees must also be made aware of their responsibilities and organizational objectives within this system in order to build a culture of quality and achieve maximum work results.
Consulting firms are often essential when operating in pharmaceuticals due to their ability to help facilitate efficient procedures and ensure data integrity by verifying that any information collected is reliable and usable. As a disclosure, my company PQE Group is one provider of such consulting services.
A strong QMS solution should foster a necessary set of processes and activities that can create fluid synergy across operations. The system that a company implements today can help serve patients tomorrow to the best of its ability, with safety as the number one priority. In this article, I will highlight some important strategies for companies to keep in mind which can help optimize their chances of success when considering a strong QMS solution for their operations.
Evaluating Systems For Success
One especially complicated aspect of the life sciences industry is maintaining compliance—especially when regulations tend to vary by country or location. A strong QMS solution should help minimize and cancel these differences. This is something The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is working to advance.
ICH brings together regulatory authorities and pharmaceutical leaders to discuss scientific and technical aspects of medicines and develop ICH guidelines. Its mission is to achieve greater global harmonization to develop safer and more effective high-quality treatments in the most resource-efficient manner while maintaining high standards.
Good manufacturing practices are described by the American FDA in the Title 21 code of federal regulations. However, in the European Union, rules vary depending on medicinal products and are under a different description of guidelines and volumes. These inconsistent regulations are why ICH works diligently to close the gaps in standards and guarantee the same quality of medicinal products in every part of the world.
Industry leaders worldwide want to minimize and cancel these differences to make operations run smoothly and safely no matter where they are. Most differences in QMS are noticed during inspections, which is why organizations such as ICH aim to guarantee the same quality of medicinal products through streamlined processes and standards. It often happens that the major difference is not in the quality system itself, but different inspectors focus on varying topics that can change depending on the county or enterprise. Having unified guidelines for QMS can help combat this problem to keep more companies in compliance and more clients happy.
Overcoming Operational Obstacles
Regardless of what issue your company may be facing, an effective QMS should be able to provide solutions to the challenges and obstacles you face. Companies should ensure a potential QMS solution provides a fundamental basis on which their businesses can build all procedures to ensure the quality and efficacy of their functions—with one of the most significant dangers relating to data integrity.
Authorities today carefully examine the data integrity in pharmaceutical companies because it proves the safety of medicinal products intended for patient use. Consequently, companies often encounter problems with this aspect because they are unaware of how to obtain and maintain reliable information. If the data becomes compromised or lost, it can result in months of work and volumes of resources for the organization to replace or recover—not to mention the damage to its reputation and customer retention.
Adopting a QMS, especially for market entry of new medications, can make it possible to collect and secure all the data and results even as regulatory bodies continue to update their guidelines. Implementing management systems can also help position information to be usable over time and render the pathway to obtaining approval for the use of medicinal products into a much smoother process. As mentioned, companies can further benefit from leveraging a strong consulting solution that specializes in these systems and quality of care to lessen the stress of keeping up with changing regulations and facilitate a more effective and positive experience and partnership.
QMS And Operational Efficiency
Facing regulatory problems and requirements on your own can become overwhelming. When establishing an effective QMS within their operations, many companies look to firms for guidance. Everyone can read a standard or regulation, but implementing their requirements is often more difficult than it seems, which is where experienced consultants can help.
Quality management systems can create a high-quality collective standard for industries to continually produce the best possible products. It is essential to understand different regulatory philosophies, their motivation and their importance in your industry.
Companies should also consider how the QMS they implement today will most effectively and safely serve the future. There is a common saying among consultants and quality assurance teams: “If something is not written, it does not exist.” That’s the way in which leveraging an effective QMS solution and consulting firm to facilitate can aid your organization in deciphering what is real, what is necessary—and what your business can do without.
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