Well past midnight a transfer hub is a quiet building: forklifts on charge, dock doors down, the ventilation the only thing still running. Along the wall stand the cartons that go out in the morning, and one of them left your pharmaceutical warehouse. Nobody is standing over it at that hour, so whatever protects the load was put in place by you, before the van pulled away.
Turkish law has a name for this pause. Article 4(1)(a) of the Regulation on Pharmaceutical Warehouses and the Products Held in Them defines a transfer hub as a temporary storage centre, and Article 7(1) allows products to be kept there for at most 72 hours, on condition that every measure relating to storage conditions has been taken. The hours come with that clause attached, and the clause is concerned with how those 72 hours are spent.
Where the clock starts. The count begins when the goods enter the facility, and the awkward case in daily work is the split delivery: a pallet is broken down at the hub, part of it goes onto the evening van, the remaining cartons wait for the next day's round. The Regulation does not describe that split separately, so whether the remainder is counted from first entry or from its last movement is something you and the service provider have to settle in writing; without that, nobody can say where the load sits against the 72-hour ceiling.
The second paragraph of the same article asks for measures that keep waiting times to a minimum and for those times to be recorded. The first half speaks to operations, the second to inspection: how long a carton stood on the dock stops being something people try to remember and becomes written data. If the last run on one lane is missed three times a week and the cartons stay until morning, that pattern now shows up in the record.
| What gets recorded | Where it says so |
|---|---|
| Maximum wait, 72 hours | Article 4(1)(a) and Article 7(1) |
| The waiting times themselves | Article 7(2) |
| Temperature and humidity values | Article 7(3) |
| Retention of records, 5 years | Article 18(9) |
What actually holds the product
For products that need special storage conditions the text becomes more concrete. Article 7(5) requires them to be held at the transfer hub in line with the conditions defined in the supplier's shipment validations, and it lists in brackets the placement of polystyrene boxes, ice packs, data loggers and similar equipment. The closed, validated package is named here not in place of the cold room but alongside it; which product waits in the cold room and which waits inside a validated box comes out of your own validation.
In practice this means something has to travel with the load besides the load itself: the instruction sheet for the package. How many ice packs, on which layer, where the logger sits, how often the lid may be opened. The night shift at the hub is not reading your validation report; it reads the label on the box and the single page clipped to the delivery note, and preparing that page belongs to the consignor.
For products stored at room temperature the picture gets lighter without emptying out: waiting times and the site's ambient values are still recorded, because paragraphs two and three of Article 7 draw no line between product groups. With a cold chain item two records overlap; the logger inside the package and the ambient record of the building describe the same hours from different angles, and in any argument about an excursion they get read together.
When the same waiting window happens on your own dock, the notes under the cold chain at a distribution centre work through these questions one by one.
The record outlives the shift
Article 18(3) of the Regulation requires temperature and humidity monitoring records to be kept in electronic form, and Article 18(9) requires all records relating to the activity to be retained for 5 years. Section 5.3 of the TİTCK Good Distribution Practices Guideline for medicinal products for human use likewise sets a minimum retention of 5 years for records and backed-up data. The data from one night at a transfer hub therefore stays on file long after everyone who worked that night has moved on.
What the Regulation does not set is the format in which that data reaches you, or how quickly. If the service contract leaves the gap open, the record an inspector asks for lives on someone else's server, in someone else's file format and often inside a short archive window. Writing the right to raw data, the file format and a delivery time on request into the contract settles cheaply what is expensive to fix afterwards.
As for where responsibility sits on that empty dock in the middle of the night, Article 7(6) states it plainly: the use of transfer hub services by pharmaceutical warehouses does not remove their responsibility for product quality. The goods wait on someone else's dock, and the account for them stays with you.
