Pharmaceuticals, nutraceuticals or health supplements that do not meet required standards can cause a lot of harm, which is why they are closely monitored and regulated.
Unfortunately, inspections done by FDA GMP in early 2017 showed that a number of dietary supplement manufacturers are not fully compliant with cGMPs, or Current Good Manufacturing Practices. This noncompliance is largely due to lack of specifications in regard to finished products and ingredients.
Because regulations are changing and compliance remains critical, quality management of the pharmaceutical and supplement industry is more important than ever. Manufacturers are challenged every day to meet strict regulations, while there is also the challenge of staying competitive in an environment that changes fast. Competition puts pressure not only on sales and marketing teams but also quality assurance departments. These departments are expected to control the quality of their products as well as costs, market distribution and other aspects while remaining compliant with given regulations.
Establishing Required Specifications through Quality Assurance Management
For quality assurance management of pharmaceuticals to be effective, the approach should be proactive. Being proactive means taking steps to ensure that product manufacturers are adhering to set standards rather than waiting to find noncompliance and reacting to those issues. Further, being proactive means putting ongoing measures into effect to improve product quality and reduce -- or eliminate -- errors.
Optimizing the reliability and efficiency of the process of quality assurance can achieve quick and effective operational performance in addition to ensuring ensure compliance.
Further, it is the QA professionals who will be able to lead the charge in establishing regulatory specifications that make sense for their particular industury. It remains to be seen whether current regulations will be relaxed, but the best way for manufacturers to remain compliant is to keep up with regulatory issues and establsh themselves as thought leaders in the industry. Quality assurance managers who are able to point to their own success in establishing safe regulatory practices will be given more latitiude by regulators and could even find themselves working for regulatory agencies in the future.
To achieve long-term compliance and success, quality assurance management also needs to:
- Lead initiatives towards enhancing quality
- Eliminate activities that don't add value to the final product
- Reduce the time needed to resolve any issues in the product process that would compromise the quality of the final product
- Reduce chances of deviations from the ideal process and final product
No Easy Feat
Achieving the ideals above is no easy feat. Great quality assurance management can only be done with the right control system which should be well-defined and strictly enforced. A control system will ensure that the required standards are attained and that improvements are made along the way.
Unfortunately, as the FDA GMP inspections showed, a good number of manufacturing companies are not doing this, citing different challenges, such as quality assurance personnel being tied up with administrative activities. The less time QA professionals spend on observing and enacting change, the more likely quality and compliance are to suffer.
Following the findings of the inspections, it is expected that manufacturers will step it up in regards to quality assurance. There is a need for companies to streamline operations by optimizing workflow and speed of operations and eliminating unnecessary tasks that waste time and resources. Companies that take quality assurance seriously now will be ready for the next FDA GMP inspections.
The FDA is known to be very strict in upholding standards and regulations. Companies that don't step up will face serious repercussions including possible closure until full compliance is proven. Manufacturers may also have to recall their products off the shelves. This is how quality assurance management can work to establish required specification.