Grupa NEUCA

Tomasz Nawrocki

Globalization in pharmaceutical industry is a fact for number of years and progressing further. India; China are the key API and finish goods manufacturing regions in pharmaceutical environment due to significantly lower costs; growing quality and lower environmental restrictions.

Number of companies base their European business models on raw materials or finished products supply form outside Europe and face issues with right first-time deliveries. There are number of challenges Marketing Authorisation Holders in Europe needs to fight against such us proper forecasting; stock management; quality issues; customer complains and much more…Working on the pharmaceutical tender business is even more challenging. Applying for the tender not having the confirmation of product delivery is simply asking for trouble…Ordering the product without winning the tender is bringing high risk of product decommissioning. How to work with product delivery lead times of over 6 months and being successful on the market? You need to work flexible and with a proper plan!

Working on efficient and flexible supply chain is the goal of each pharmaceutical company. The pupil of the eye is to mitigate the risk on the product supply chain and delivery of right product; right time; right quantity and quality…

One of the remedies to deliver these goals is the Late Pack Customisation approach. I basically stand for customization of the product as late with in supply chain and as close to the customer as possible. The product manufacturing and primary packaging is delivered at the manufacturing site for all the markets – same primary pack/ non customized artwork. The primary product packaging requires attention and proper design not to destruct the primary pack during the shipment. The market specific/customized secondary packaging is delivered just before the supply to the final customer.

This is the most efficient and flexible supply chain design which allows to take decisions on quantity of product just before the supply to the market and benefit from low-cost high-volume manufacturing centres outside Europe.  The “core” manufacturing site benefits from low sku (stock keeping units) number; low raw material variability and high product volume, which brings efficiency on operational excellence and cost savings. The “local” site delivers the flexibility for decision makers. The customization of the product is late within supply chain which allows to be flexible on the quantity of product per country/customer or even change the final product destination to more profitable market within the region... due to the fact that the local/regional stock of primary raw material for final customization is stored and assembled – next to the market.

The customized volume & final market destination decision is not taken at the forecasting or product order setting point of time which might be 6 or more months before product reaches the market,but it is based on the current market situation that tends to change significantly.  

Case..

European marketing team is ordering the tablet product in vials at India site. The site is manufacturing the product according to non-market specific specifications – nude vials with product (for blisters- with common (non-market specific) aluminium foil print). After QA/QC verification and testing the product is packed and shipped to the region i.e. Europe. It is highly important to properly secure the product form destruction as there is no secondary packaging. After import activity of semi product the primary pack (nude vial or blank blister) is sampled and send to QC laboratory for analytical testing. At the European importer the product is customized. For the semi product vials it is labelled; for blister printed if required with market specific information’s and packed in to final customized per market product. The customized packaging operation is based on quantity from the order of MaH/ marketing team located at the market having the latest sales/proportion data.

Same product flow might be used of syringed; vials; MDI or cream & ointments. There are no limitations to the process design.

Late Pack Customization requires proper product dossier & supply chain preparation however it delivers number of benefits from high operational excellence at the manufacturing centre though optimization of QA/QC cost on the semi product and last not least fast and flexible market reaction which delivers critical market competition advantage.