News.

There is a familiar shape to artwork projects. Brand wants a pack that looks like the brand. Regulatory wants a pack that carries every statutory particular in the approved wording. The two negotiate, someone concedes, and the result is a compromise neither side defends with much enthusiasm. That framing is wrong, and it produces worse … Continued

Most labelling problems are not caught by the regulator. They are caught at goods-in, when a packer compares a delivered carton against the approved artwork and finds a missing excipient declaration, a superseded marketing authorisation holder address or a coding panel too small for the batch code. By then the print run exists, the line … Continued

For a sterile medical device, the pack is not a container. It holds sterility from the moment the device leaves the steriliser until a nurse opens it at the sterile field, sometimes five years later. Get the material, the seal or the ageing evidence wrong and the device cannot be sold, however well it performs. … Continued

Uncontrolled artwork is one of the most persistent root causes behind packaging recalls. Not a bad design: the wrong version of a good one. A superseded file gets sent to the printer, an old strength statement survives a revision, two people work on parallel copies and neither knows the other exists. Graphic design for pharmaceutical … Continued

A carton that looks correct on screen can still fail on an automatic cartoner. It jams on the tuck, the crease cracks, the glue flap peels, or the pack runs at half the quoted speed because the board is fighting the machine. None of that is a graphics problem. It is structural. Pharmaceutical box design … Continued

Most pharmaceutical packaging design problems are found too late. The artwork is signed off, the cartons are printed, and the first thing anyone discovers is that the Braille sits across a crease, the coding panel is under a gloss varnish, or the strength is set in a point size the assessor will not accept. At … Continued

Choosing a cell therapy logistics partner is not a procurement exercise with a quality annexe attached. The provider joins a chain where a single failure ends one patient’s treatment, and where you remain accountable as contract giver regardless of who handled the material. The questions below are organised by theme, each with what a good … Continued

The rulebook is the same document. EU Guidelines on Good Distribution Practice of medicinal products for human use, 2013/C 343/01, retained in UK law and enforced by the MHRA through the Wholesale Dealer’s Authorisation, WDA(H), with a named Responsible Person. If you already run a compliant wholesale operation, none of the chapter headings will be … Continued

In an autologous therapy, the product is made from one patient and can only be given back to that patient. Everything in gene therapy logistics follows from that fact. There is no second batch on the shelf and no way to make good a mistake after the event. Chain of identity is the control that … Continued

Cryogenic storage is the least forgiving part of cell & gene logistics. A refrigerated product that warms briefly can often be assessed against stability data and released. A cell therapy that crosses its glass transition temperature on the way back up may have lost viability that no amount of subsequent cooling recovers. This explainer covers … Continued

Most articles on advanced therapy supply chains are written for the sponsor. This one is written for the other side of the technical agreement: the contract packer, storage provider or distributor being asked to take on ATMP work, and the sponsor auditor who wants to know what good looks like. Taking on cell therapy logistics … Continued

A misrouted pallet of tablets is a stock problem. A misrouted bag of apheresis material is a patient problem, because there is no second batch, and the patient may already be part-way through a conditioning regimen timed around a delivery date that has now passed. That single difference drives almost everything unusual about cell and … Continued