Properly packaging a product of any sort can be one of the most overlooked aspects in manufacturing across the board. It is easy to become focused on the product itself but many simply overlook the delivery model. Even if a product is of the highest quality and most effective in their market, these accolades are obsolete if the packaging process is not fine tuned. In the Pharmaceutical Industry, it is absolutely imperative that the drug is delivered properly and most accurately due to the sensitivity of the end consumer and potential adverse outcomes downstream.
Below are six key aspects to the validation of packaging for pharmaceuticals:
- Preservation– The product must remain uncontaminated from exterior elements such as moisture, light and gases. This is key to maintaining the integrity of the medication located inside the packaging. For example, cold-formed aluminum blocks and vials block out light. Other products are more fragile and require an insert inside the bottle to protect tablets from breaking during the shipment.
- Containment– The product cannot be subject to leakage due to seals or other faulty packaging. There must be consistent measures in place to validate the packaging itself to avoid a containment failure downstream.
- Identification– The product must be properly identified and have traceability due to the federal serialization standards. 2D DataMatrix barcodes must be graded to maintain a uniform level of quality. Offline or online grading is strongly recommended.
- Security– With evolving national epidemics, such as the increased use of opioids for recreational use, security of a product has never been more important. The product should be secured for tampering but also for traceability.
- Information– The product must have proper documentation on file to be able to be properly traced and be accounted for in production and distribution. Automating this process is preferred due to the rigorous standards that have been put in place to be DSCDA compliant.
- Delivery Convenience– The product must be convenient for clinicians to be able to administer with ease of use. The packaging plays a crucial role in patient delivery and should not be overlooked.
These six elements are key to high quality pharmaceutical packaging. Sometimes there are only a few areas that manufacturers struggle with remaining compliant. RemTech has worked with hundreds of manufacturers, large and small, to manage packaging processes and make sure that clients are not only DSCDA compliant but also prepared for new rules and regulation changes down the road.
For questions, contact John Hartwig at firstname.lastname@example.org