In the quest to maintain FDA compliance norms have Pharmaceutical companies lost sight of quality excellence? Today, there is practically no activity conducted by the pharmaceutical industry that is not monitored for compliance. Systems like Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs) and Good Manufacturing Practices (GMPs) all come with a precise list of requirements.
These compliance guidelines in turn determine every aspect of research, development, clinical tests and trials, manufacturing, and marketing. In addition, such compliance management and FDA audits add to the overall high expenses of any organization. It comes as no surprise that pharmaceutical companies are lagging behind in the quest for Quality Excellence when faced with such intense regulatory procedures.
Keeping this in mind, the FDA has recently established an Office of Pharmaceutical Quality to improve the checking of drug quality and overall excellence. There needs to be a significant change in focus from compliance to concentrating on quality. Here are some of the ways quality excellence can improve.
Establish new metrics
The FDA agrees that using new quality metrics can help promote a quality driven culture instead of merely a compliant one. Today we have no concrete ways to track if quality is improving. To put it bluntly, quality excellence standards don’t exist. This drive towards a new metric also indicates a push away from individual reporting and reactive behavior. No longer can the FDA rely on soft metrics and anecdotal evidence. The hunt is now on for a common language to define and measure quality in the pharma industry. The road may be long but the intentions are sound and can only help the industry in the long run.
Prioritizing resources
When inventory veers into the range of thousands of different products, supply chains are being stretched to their limits. As a result drug quality concerns may arise and recalls have doubled over the past ten years. By keeping a closer check on specific links in the production chain and maintaining detailed records, the possibly of straying from standards and the need for inspections can lessen.
Benchmarking
All companies can benefit from benchmarking. What this entails is the identification and adoption of the best practices across internal departments and external organizations that contribute towards an overall improvement of quality. Quality management benchmarking in particular can help increase inter-departmental communications and analyze cost and risks to improve the financial health of the company.
Leveraging technology
The need of the hour is tight coordination among all the IT systems of any organization. However, many companies still shy away from investing the necessary time and costs towards developing such systems. But without a robust document management system, compliance can rarely move towards quality excellence. Tracking documents and reports, analyzing trends, and maintaining compliance standards can all be accomplished with the correct technology. The trick is getting companies to use these systems to their full potential and maximizing all their benefits.
Compliance plays a huge part in any operation within the industry. If you have not yet tried the HawkScanner product compliance database, be ahead of the game and be sure to sign up for a free account.