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Device packaging is regulated as part of the device. The carton, the label, the pouch, the tray and the instructions for use are not accessories; for a sterile device the packaging is a functional component that maintains sterility until the point of use. That is why selecting a medical packaging company for devices differs from … Continued

The two terms get used interchangeably in tender documents, and should not be. In serialisation pharma projects, mixing them up creates scope gaps that surface when a customer’s first US shipment is rejected for missing case data. Serialisation is about identity. Aggregation is about relationship. A site can serialise without aggregating. It cannot aggregate without … Continued

Pharmaceutical serialisation gives every saleable pack its own identity. Not a batch identity shared with 200,000 other cartons, but a number belonging to that carton alone, printed on it, recorded in a database and checkable at any point between the packing line and the patient. The mechanics are well established. What changes is which markets … Continued

A marketing authorisation holder with a US product and a European packing site runs into a question MHRA licensing cannot answer: is the site registered with the FDA? Not audited, not accredited. Registered. Without it, product packed at that site cannot lawfully be offered for import into the United States. This is one of the … Continued

Regulatory affairs usually appears in the supply chain conversation as a cost line and a delay: something to satisfy before product can move, owned by another function, discussed after the network is designed. That sequencing is backwards. In pharmaceutical contract packaging, regulatory position is not a constraint applied to a supply chain. It is one … Continued

Most buyers assess a contract packer on capability: line speeds, formats, capacity, price. The licence position gets a tick in a questionnaire. That is the wrong way round. The licence decides what a site is legally allowed to do with your product, and no amount of equipment compensates for an activity that is not on … Continued

A batch can be fully packed, fully tested, correctly labelled and sitting on a pallet in a licensed warehouse, and still be legally worthless. Until a Qualified Person has certified it, it is not a medicine that can be placed on the market. It is stock. QP release is where every other strand of pharma … Continued

Building your own licensed warehouse is a large capital decision taken before you have shipped a pallet. Racking, qualified temperature zones, monitoring, a controlled drug vault, a warehouse management system, a Responsible Person, an MHRA inspection, a WDA(H). Then you carry all of it whether the volume arrives or not. That arithmetic is why most … Continued

A pharmacy orders four packs. A hospital orders a pallet. A clinical site orders two chilled cartons that must arrive before nine tomorrow morning. All three hit the same warehouse, the same stock and the same team, and all three must leave with a complete batch and expiry record attached. That is the difference between … Continued

If you own a medicinal product supply chain, GDP is the standard your pharma warehousing is held to from the moment a batch is certified until it reaches your customer. It is also the standard the MHRA will inspect that warehouse against, whether it is yours or somebody else’s. The document itself is short. The … Continued

Most companies discover the difficulty of controlled drug storage late, usually when a product moves from clinical supply into commercial volumes and somebody asks where the stock will sit. The answer is not a lockable cupboard in the corner of a warehouse. Controlled drugs sit under a separate legal regime from the rest of your … Continued

A cold room alarm fires at 02:40 on a Sunday. Nobody is on site. By the time somebody opens the notification on Monday morning, the stock inside has spent a day and a half at a temperature nobody can now reconstruct. Pharmaceutical cold storage is rarely lost to refrigeration engineering. It is lost in the … Continued