Initial Classification of a Commercial Return (CR) by the CR Coordinator

For the criteria to be fulfilled for the first classification, Sample Pharma GmbH has focused, among other things, on the economic aspect. If the quantity of medicinal products to be returned is too small, it is possible that the costs arising from the return will not be covered by the resale. Alternatively, if the shelf life is too short, one may be left with the goods. In these cases, it is advisable not to return the goods but to have them destroyed directly by the customer.

If a pharmaceutical company manufactures supply-relevant or supply-critical active substances or medicinal products, then the economic aspect can be secondary and the medicinal product is not sorted out for commercial reasons, but goes through the evaluation process for a possible resale.

Sample Pharma GmbH does not distribute any supply-relevant or supply-critical active substances or medicinal products.

After receiving the electronically transmitted return notification, the CR coordinator from the sales group decides whether the return notification should be rejected, the goods physically returned or destroyed by the customer.

Quality-relevant prerequisites for a return

The customer has confirmed in his return notification that

• the listed goods have been properly stored and handled since delivery by Sample Pharma GmbH,
• temperature records are available that show no deviations and can be provided upon request,
• the medicinal products specified have not left the customer's area of responsibility and are in their original condition.

Sample Pharma GmbH does not take back goods that have been delivered to third parties via wholesalers. The reason for this is that no assessment of the transport route from the wholesaler to third parties can be made.

Economic prerequisites for a return

If the quality-relevant prerequisites are met, the CR coordinator carries out an economic evaluation of the commercial return. The decision factors "discontinued article", "remaining minimum shelf life" and "value of goods" should be queried with the following criteria:

• Presorting for discontinued articles
• Goods with a short remaining shelf life (≤ 7 months)
• Value of goods of the medicinal products to be returned is ≤ € 3,000

Decision

Three decision options are possible:

Option I ("rejected"): The sales department rejects the commercial return because the described quality-relevant requirements are not met. The customer is informed by the CR coordinator. The process is completed.

Option II ("destruction at the customer's premises"): If at least one of the three commercial prerequisites has been ticked with "yes" for a product, then there is no longer any commercial viability for this item. If this is the case, then the sales department recognises the commercial return.

The customer will be informed by the CR coordinator and instructed to destroy the goods himself due to lack of economic viability. If costs have been incurred by the customer for the destruction, these will be reimbursed by Sample Pharma GmbH if this has been contractually agreed. The process is completed.

Option III ("approved"): The sales department acknowledges the commercial return.

The CR coordinator prepares the retrieval, this also includes the feedback to the customer.

The system generates a returns slip for all articles of option III from the returns notification. The CR coordinator sends this electronically to the customer with the instruction to enclose the returns slip with the return.

In addition, the CR coordinator gives written notice of the pending return, including a copy of the returns slip, to the incoming goods department (incominggoods@sample-pharma.com).

Definitions

Commercial return (CR): Collective term for wrong delivery, over-delivery, short remaining time, cancellation of order after delivery, AV articles and transport damage.

CR coordinator: Team member of the sales group responsible for the organisational handling of commercial returns.

The text in a translated and shortened excerpt from the German sample SOP 790 „Umgang mit kommerziellen Retouren (handling of commercial returns)“.