Last March, the European Union published updated guidelines in the Eudralex – Volume 4: Good manufacturing practice (GMP) Guidelines. The chapters on Premise and Equipment, Production and Complaints and Product Recall were updated. Later this year, an updated Annex 15 about Qualification and validation will come into operation. The bottom line: the rules will become stricter and more detailed. Manufacturing authorisation holders are not only required to assess their entire supply chain, but also need to document all the steps they take to guarantee product quality. As a company working in the pharmaceutical or medical industry within the European Union you face many challenges and rules – like the GMP guidelines – regarding the development, manufacturing and control of medicinal and medical products. Each product needs a quality control process to guarantee that it meets all demands and complies with the – often rapidly changing – regulations. How do you keep up-to-date on quality rules, requirements and guidelines? A 4-point checklist to meet accreditation quality assurance:
1. Replace paperwork by a digital quality management system
Compared to paper-based systems, documents in digital form bring along a lot of advantages when it comes to quality management. For example, mixing up different document versions becomes a thing of the past, and all your employees can easily access the latest versions (and only the latest versions!) of all documents. Also, a regularly update can be assured by an automated reminder system. Any possible amendments in guidelines like GMP are implemented faster, cheaper and more accurately compared to a manual approach. Most important advantage: all your documents can be linked to other systems, for example your training system. Enough reasons to transform your business into a ‘paperless office’.
2. Guarantee optimal communication between R&D and Production
Bringing new medical or pharmaceutical products onto the market can take years, but rules and guidelines are changing quickly. To prevent a loss of income and speed up the registration process, efficient communication between the Research & Development and Production division is required. That means creating a standardised approach and policies for the production process, control strategy and process validation. This can be achieved by the use of a Lean Technology Transfer Framework, which consists of a scenario approach combined with templates for instance. The transfer serves as a lingua franca to ensure understanding between both R&D and Production, resulting in a faster, more efficient and validated product launch.
3. Become fast and easily compliant with a quick scan
Especially for new companies, it’s not easy to comply with and know all the necessary legislations and rules. With a quick scan of your quality system, you quickly and efficiently gain an insight into the state, compliance and possible gaps of your company’s quality management processes. Within a couple of days you have a list of insights and required actions at your disposal to improve your processes. A real must in case of rapidly changing rules and requirements.
4. Choose your quality management expert with care
Last but not least, summon the help of a quality management expert to guarantee full compliance of your products. Not only do experts keep a close track of all the important amendments in quality requirements and regulations, they also help to reinforce a company’s immune system, keep control of risks associated with quality and increase the profitability of businesses. And that’s important, because few sectors are exposed to risk more than the medical and pharmaceutical industries, and problems with quality or patient safety can result in very high legal claims. The right quality management system is the best remedy to ensure optimal medical and pharmaceutical quality control and pass every change in rules or requirements effortless.
Improve your quality control system today!
QbD offers numerous training sessions that will prepare you to optimize your quality control systems. Interested? Check out our training programs in the QbD Academy. Are you looking for an expert to help you set up or improve your quality control system? Contact us today!