Supply Chain Management

Supply Chain Management (SCM) in medical device and pharmaceutical industries is often complex and features multiple stakeholders. It’s not only about on-time deliveries or creating safety stocks for critical materials, but also building long term relationships with suppliers whose materials or components have been incorporated into the validated final product with files submitted to regulatory bodies. Every change to a component requires notification and for adjustments to be made in the quality documents. If cost savings (are achieved) significance is added, the overall supply chain management becomes a process requiring a regulated structured approach as well as staying very close to suppliers.

Supply chain management for a contract manufacturer adds an additional layer to the above. Working with devices and medicinal products in various life cycle stages, a contract manufacturer works with two types of suppliers:

• Those assigned by the customer
• Those recommended by a contract manufacturer

Both types need the same approach to vendor management. They are required to be assessed from a critical point of view and qualified accordingly. Their on-time and in-full delivery performance needs to be monitored and assessed on a regular basis. Any changes in an original material specification must come with an advanced notification to assess their impact on the final product and amend relevant documentation. Developing a new supplier in a medical device or pharmaceutical product requires strong project management skills, providing a mix of key accounting and quality management. In the end of the supply chain management process, just like any other process in the healthcare world, there is a patient, his or her life and safety.

To ensure efficiency across a customer’s network, the vendor management team works to uphold and maintain the standard of excellence set by the SteriPack. This includes critical risk assessment to define the vendors category and identify any product and financial risks. Offering customers a strategic partnership, the SteriPack has the experience to provide vendor quality evaluation, performance monitoring and auditing selected vendors to make sure they meet the group’s criteria.

•  Core services in supply chain management:
•  Vendor management
•  Sourcing of raw materials, components and packaging materials
•  Incoming inspection
•  Demand planning and inventory management
•  Vendor managed inventory
•  Purchasing
•  Transport and logistics, warehousing
•  Cost and process optimization
•  EDI ERP integration

For vendors that excel, the SteriPack rewards them with “recommended” status and will prioritize them in future projects. To maintain excellence, we offer:

•  Self-assessment questionnaire for all suppliers
•  Quality certification assessment – ISO, FDA, GMP, etc.
•  Auditing of critical suppliers
•  QAA and supply agreements in place for critical suppliers

Material specification based on information from vendors, linked to purchase orders