Once product has been manufactured and packaged, there are requirements for how you handle, store and distribute the finished product. 21 CFR 820 breaks down the requirements for each of these processes. A manufacturing company should establish procedures that will deter mix-ups, damage, deterioration or contamination from happening during handling and storage of product. These procedures should make sure that obsolete, rejected or deteriorated product is not used or distributed. There should also be documented processes on how to authorize receipt from, and addition to, storage areas and stock rooms.
ISO 9001’s requirements are similar to the FDA’s: “The organization shall preserve the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, preservation shall include identification, handling, packaging, storage and protection.”
In regards to distribution, a manufacturer needs to be confident that only devices approved for release into inventory have been distributed. Purchase orders need to be reviewed in order to resolve any errors or discrepancies prior to distribution. It is a requirement to maintain documentation regarding the name and address of the person and/or company purchasing the product; identify which product and quantity was shipped along with the date the order was completed. Any environmental requirements for the device, while in storage or in transit, must be defined and controlled throughout the product’s shelf-life.
Let’s talk DryCal!
Talk with one of our experts to get your questions answered and see how we can help you solve your calibrator pain points.