9 Check Points for the Incoming Goods Protocol at the Logistician's or Wholesaler's Premises

General procedure

The incoming goods control begins with checking whether the delivery corresponds to the delivery note or consignment note and corresponds to an order or an announced return. The entire delivery must be checked and the results documented. A checklist can be used for this purpose, which is to be filled out in the form of a protocol.

The incoming goods protocol must be filled out completely. The date of the delivery and the names of the employees for unloading and control must be indicated. The correctness must be confirmed with the signature(s) of the persons involved. Subsequent entries must be marked as such.

The following inspection points are to be listed on the incoming goods protocol:

• Do the goods correspond to the information on the delivery note?
• Can the goods be identified precisely? Check the item number, batch and expiry date/shelf life.
• Was the correct quantity delivered?
• Is special storage required?
• Are the goods intact (including closure system, e.g. seal)? Check for damage or contamination.
• If applicable: Are the security features intact?
• For APIs: Are seals present and undamaged?
• For APIs: Are the certificates of analysis, including those of the original manufacturer (the identity of the original manufacturer must be known to the pharmaceutical company, there is a duty to inform here), enclosed with the supplied documents?
• For temperature-sensitive products: Are the temperature printouts of the refrigerated semi-trailer as well as those of the supplied data loggers (if any) complete and legible for the required period? Were there any temperature deviations?

A proof must be attached to the incoming goods protocol showing the batch designations of the entire delivery.

Refrigerated goods may only be unloaded in the corresponding temperature zone (if possible) or areto be moved directly to the corresponding temperature zones. Products that require special safety measures must be prioritised and moved to their designated storage areas immediately after the incoming goods control.

After completion of the incoming goods control, the goods are usually booked into the warehouse management system of Peither Logistik GmbH. In special cases, the receipt of the goods is confirmed directly in the customer system (warehouse management system of the pharmaceutical company).

The incoming goods process is completed when the goods have been moved to the designated storage location.

Goods receipt of medicinal products in quarantine status

As a matter of principle, medicinal products may only be placed on the market if they have been authorised for this purpose (marketing authorisation). In addition, each individual batch of medicinal products must be certified by a Qualified Person (QP) (batch certification and release for marketing, see Annex 16 EU GMP Guide).

The certification of the finished product batch may only be carried out by the QP if the required prerequisites are fulfilled. Due to the prescribed tests, batches of medicinal products often cannot be released for marketing immediately after their manufacture (e.g. waiting times for microbiological tests). This means that finished medicinal products must first be stored before they can be released for marketing. However, it must then be ensured that such non-certified batches cannot be transferred to marketable stock. This may involve physical precautions such as segregation and labelling, or electronic precautions such as the use of validated computerised systems.

In practice, the following applies: If a logistician receives batches of medicinal products that have not yet been certified by the qualified person, it is not permissible to add them to the saleable stock. Instead, they are first booked into the quarantine stock and, depending on the process definition, the containers are also marked accordingly. Only when the goods have been released can the transfer posting be made to the sales stock/free stock.

Requirements for the incoming goods infrastructure

• The incoming goods area must be protected from the weather.
• The incoming goods area must be sufficiently separated from the storage area and the shipping area.
• The areas where incoming goods controls are carried out should be clearly marked and adequately lit.
• The staging areas must be large enough to be able to carry out batch separation.
• In the case of so-called multi-user centres, care must be taken to ensure sufficient physical separation and identification when processing incoming goods for the individual customers; if physical proximity is unavoidable, e.g. due to capacity bottlenecks, separation can be made with the help of barrier tapes.

Counterfeit products

If counterfeit products are suspected, the affected cargo must be immediately physically separated from the rest of the goods. In the case of counterfeit medicines, the pharmaceutical manufacturer and the competent authority must be informed. All measures taken must be documented.

Control of temperature-sensitive products

Chilled goods and temperature-controlled transports are to be prioritised in order to bring them – after temperature control – into the temperature-controlled storage rooms as quickly as possible.

To check whether the temperature was maintained during transport, evaluate the printouts of the data loggers of the transport vehicles. If this is not possible, at least check the temperature of the delivery with a calibrated measuring device upon receipt of the goods. The results are to be documented and the records including the logger printouts are to be archived. In the event of a deviation, this is to be processed according to previously established procedures.

If larger quantities of temperature-sensitive medicines are delivered or collected daily, it makes sense to set up a loading area with direct access to the cold storage (thermal door). In this way, temperature fluctuations can be avoided and the transport routes for the sensitive medicines can be optimised.

Figure 1: Thermal door in the cold store at Grieshaber Logistics Group AG

A translated and edited excerpt from our German knowledge portal GMP:KnowHow Pharmalogistik (GDP).