By Rabih Karam, Sales Manager, Healthcare Dispensing Systems.
Select the Right Pump Packaging Partner for Rx Ear, Nose, Throat or Topical Medications
1. Does the supplier offer the drug delivery system that I need, or are they willing to partner with me to create it?
The right supplier is one that responds quickly to needs from both individual customers and the market as a whole. Look for a packaging supplier that not only offers an existing product with secure supply that meets your needs, but also has a history of partnering with customers to develop custom, manufacturable drug delivery devices to meet new needs.
2. Are the packaging materials utilized by the supplier compatible with my drug?
The supplier should have a broad range of pharmaceutical and medical grade materials available in order to select the most suitable materials for the application, balancing engineering performance, manufacturability, cost and drug contact suitability. For drug contact materials, the supplier should have the respective extractables data for each material, and they should ideally have more than one option due to potential API degradation with certain materials. While the final evaluation of material safety and efficacy is via a leachables study, extractables data can quickly rule in or rule out material options. Lastly, the supplier should practice change control in accordance with GMP and ISO guidance, so that, should changes be necessary, extractables and leachables studies can be rerun to ensure the material safety and efficacy information filed with the regulatory body is current.
3. Does the supplier have a proven track record of abiding by good manufacturing practices?
Your drug delivery device supplier should produce and deliver in conformance with pharma GMP as well as with the pre-established technical specifications for that project. Ensure that the supplier has a strong audit track record with regulatory bodies and ISO. Each product component should be manufactured according to your agreed-upon procedures, and the manufacturing environment should be commensurate with the needs driven by the product specifications (i.e. particulate and contaminant count, bioburden limits, cosmetic requirements, etc.) To guarantee this, your supplier should agree to allow access to its production site for audit purposes. Additionally, the supplier should agree to provide ongoing, prior notifications about any major changes to the following:
- Quality control systems
- Technical specifications
- Raw materials
4. Will their commercial terms, including price and flexibility, ultimately lead to a positive ROI?
Selecting the right supplier could significantly reduce your per-unit price, and ultimately, off-set any switching costs to enable higher profits for your brands. In order to maximize switching benefits, procurement should take into consideration how sourcing decisions impact the quality and design of the product, the production schedule, the product’s lead time, inventory costs, shipping costs and cash flow. Your supplier should have a collaborative approach to determine the optimal mix of unit price, investment in change, performance, reliability and responsiveness, as well as speed or time-to-market, which will in the end lead to greater profitability for you.
5. Does the supplier leverage an insights to in-market approach?
Developing innovative packaging starts with understanding that the best designs emerge from the best insights. Your medication packaging supplier should know the trends, know the market and know consumers – and then partner with their customers to create packaging designs to meet those needs. Packaging matters to the consumer. More than 80 percent of healthcare consumers say packaging has an impact on their purchase decisions. i
6. Does the supplier offer regulatory support?
Your drug delivery device supplier should not only follow regulatory requirements and trends, but they should also respond to support you through regulatory filings. You should receive documentation and data, such as materials of construction, sub-assembly drawings, product specifications and relevant DMF information to support your submissions.
7. Is the supplier easy to work with?
A positive working relationship can make all the difference. When your supplier takes the time to get to know you and responds quickly to the unique needs of your business, you will ultimately end up with high performance products, a smooth manufacturing process and satisfied internal and external stakeholders. In cases where you are looking for an alternative supplier to an existing product, ask the new supplier how they would approach the switching process and make sure they have the technical and regulatory support necessary to make such a change cost effective and successful from a regulatory standpoint.
iMWV Quantitative Consumer Preference Study, 2013.