Drug combination products are versatile because they include both drugs and devices in one package. That can improve the drug's effectiveness and convenience. If you're looking to make one of these products for a particular health or medical benefit, remember these tips.
Put an Equal Amount of Attention on the Quality of All Relevant Systems
Since drug combination products will include more than just a drug, you want to put an equal amount of attention on the quality of each product involved. That's going to help you make sure consumers remain safe when using these products, whether it's a syringe full of medicine or metered-dose inhalers.
You don't want to overlook any quality aspect regardless of how many systems are included in your drug combination product. More work will be involved, but if you have a good quality control system and keep up with design changes, maintaining quality will be more achievable.
Rely on Risk-Based Analysis
When you first start designing and manufacturing a drug combination product, there are inherent risks you need to account for. Assessing them early on is known as risk-based analysis and it's key for making sure you address all relevant safety concerns before a drug combination product is produced.
You have to be honest in this assessment, make the appropriate changes when they're necessary, and continue monitoring risks even after your drug combination product is put on the market. These measures will help improve safety for all consumers that use said products.
Know When to Stop Making Changes with Designs
There is going to be a point in development when you need to stop making changes to the design of your drug combination product. It's known as a design freeze and is paramount for getting approved by the appropriate regulatory bodies.
They have to review your designs, and changing them at the last minute would delay your drug combination product from getting approved and put on the market. Usually, you want to stop making design changes to this product once you're ready to submit it for approval. Just make sure you perform enough analysis and testing prior to this design stop so you can make sure everything has been ironed out.
There are a lot of important steps that must take place when developing a drug combination product. If you know what these are and follow them as carefully as you can, you'll save your company a lot of issues and money.
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