Recall of pharmaceuticals – What happens in a crisis?

The recall must take effect fast to avoid possible risks to patients and to prevent long-term damage to the manufacturer’s image. A complete recall of one or more products is usually indispensable. In this case, all processes must be structured and reliably intermeshed to guarantee that each affected product is withdrawn from circulation. To ensure that this happens, we at arvato services healthcare define the sequence of all required steps in advance, right down to the last detail.

It is 9 a.m. Whilst the morning’s drugs are being issued in a Polish hospital, the nurse responsible discovers contaminated ampoules in a pack of pharmaceuticals.  The nurse immediately decides to inform the hospital management, which in turn immediately notifies the manufacturer. Serious harm can occur if the drugs are administered to patients. Since other packs may also be affected, immediate action is vital. The affected manufacturer resolves to recall all the product on a wide scale.

The fictional scenario described here during a practice recall can have a serious impact on a pharmaceuticals manufacturer in reality. In a crisis, immediate action is required. The recall must take effect fast to avoid possible risks to patients and to prevent long-term damage to the manufacturer’s image. A complete recall of one or more products is usually indispensable. In this case, all processes must be structured and reliably intermeshed to guarantee that each affected product is withdrawn from circulation. To ensure that this happens, we at arvato services healthcare define the sequence of all required steps in advance, right down to the last detail.

“We talk to our customers, agree on individual work instructions or standard operating procedures (SOPs.) The SOPs apply to all customer products that are stored at arvato services healthcare and guarantee quick responses plus careful implementation of structured work processes. All processes are based on the international cGxP regulations,” explains Carsten Thiemt, Quality manager and Qualified person at arvato services healthcare.

Standard operating procedures to ensure safety and speed

Thanks to customised standard operating procedures and the SAP system which contains precise data on all shipments and inventory quantities of a product, arvato services healthcare can implement a widespread recall of all drugs in the shortest possible time.

“To take appropriate action in a crisis, we and our customers regularly conduct practice recalls as described in the simulated situation above. We train for the real thing, so that we are as prepared as possible when it really matters. It is true that such recalls have never actually occurred, but it shows what sets us apart: the great sense of responsibility we feel in dealing with vital medical products. All processes are planned and practiced with the greatest care. This is the only way to offer maximum safety to our customers and to their customers,” says Thiemt.

At 9:30 a.m. the pharmaceuticals manufacturer notifies the customer manager and the quality control department at arvato services healthcare, with which the manufacturer begins to recall its affected drug. A few minutes later, the customer manager and quality control team inform all concerned departments and people at arvato services healthcare. By 9:55 a.m., the product in question is blocked in the SAP system and quarantined in the warehouse. This ensures that no further units of the product in question are shipped.

All relevant information on the recalled product, the inventory levels and the shipment quantities are entered in the “Recall” form. This form is used to document all the steps carried out during the recall so that these can be traced later on. It is now 10:05 a.m. At 10:15 a.m. the notification by the pharmaceuticals manufacturer is forwarded to all affected regional warehouses and logistics partners by e-mail, fax, or phone.

10:30 a.m.: our SAP system is tailored to the pharmaceuticals industry, so it provides excellent coverage of the entire logistics process chain. As a result, arvato services healthcare can immediately check in SAP to find out the dates, recipients and quantities of an affected batch.

The pharmaceuticals manufacturer then sends the exact wording of a covering letter for each affected country, requesting the return of the affected product, to all customers which have received the batch in question. During the next few working days, the goods still in the possession of the customer are returned to arvato services healthcare or are collected directly. The products are specially marked in the incoming goods department and then booked into the quarantine warehouse. The pharmaceuticals manufacturer decides on further usage and procedure.

“Since all drug recall processes are clearly defined, arvato services healthcare communicated and reacted quickly and reliably during recall,” comments Rikke Larsen, Recall Co-ordinator in Lundbeck, talking about a practice recall recently conducted with arvato services healthcare.