Guidance In Manufacturer Contracts: Sterilization and Packaging
A recent article in Medical Device Link provided insight for materials managers on choosing contract manufacturers, considering factors involved in product sterilization and packaging. The article briefly details six different small to medium sized organizations worth, in their estimation, considering.
Referenced in sterility and packing considerations are certification from the Food and Drug Administration, as well as compliance with ISO 9001 and 13485. Manufacturers that maintain these standards indicate a significant organizational commitment to maintaining the quality of products delivered to customers.
Support services are another factor to consider in assessing suppliers, such as quality system management, packing development and validation, regulatory control, document control and recordkeeping, and warehousing and product distribution.
Organizations may also want to evaluate sterility procedures, reflected by cleanliness certification. That ensures compliance with both cleanliness standards and regular environmental monitoring. As well, compliance with testing standards is generally assured with by an ongoing collaborative relationship with the sterilization facility, through ongoing communication with the manufacturing facility.
Benefits of this level of compliance includes sterilization and validation of products received from manufacturers. As well, it indicates an ability of suppliers to quickly move their products from sterilization to packaging and distribution to customers.
Smaller manufacturers, even to those with medium-sized facilities offer potential benefits for many smaller facilities.
October 19, 2007 Related topics: Policies & Procedures, Benchmarking, Materials Management