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Pharmaceutical Manufacturing and Packing Sourcer

Industry Insight

The Falsified Medicines Directive (FMD) aims to reduce the number of counterfeit medicines infiltrating the legal supply chain in the European pharma industry. Although introduced in 2011, full implementation will not take place until January 2016 – at which time, manufacturers that fail to comply with the directive will have to withdraw their products from the EU market.

One of the core requirements of the legislation is the coding of individual pharmaceutical packs using machine-readable two-dimensional data matrix codes. Richard Pether at Rotech discusses how the majority of manufacturers will have to upgrade their production lines to accommodate the sophisticated coding and image recognition systems that are capable of working at sufficiently high speeds. He acknowledges that the timetable for FMD implementation is tight, but posits that coding is a core capability and without it companies will not be able to manufacture – leaving no margin for error.

3C Integrity Consulting’s Ian Haynes observes that many pharma companies are dangerously behind in their implementation strategies of the FMD. He wonders if this could lead to a dramatic shake-up of the industry, drawing an analogy between the directive’s impending deadline and the occurrence of mass extinction events in the Earth’s history.

Haynes also takes Pether’s arguments further into the pharmacy, noting that from 2018, a pack identifier code will have to be scanned at the point of dispensing. This will allow almost instantaneous automatic checks to be carried out against a Europe-wide medicines verification structure, providing the pharmacist with feedback on whether the dispensed product is genuine or counterfeit.

Such a move will represent an enormous step in terms of patient safety, but achieving it will require much work by the EU’s pharma manufacturers. This is a task that cannot be avoided, and those companies that fail to meet the demands of the FMD could well be driven to extinction. He forecasts it is likely that a number of established businesses today will not survive.

Diane Palmquist at GT Nexus looks at an alternative angle in the battle against counterfeit drugs: increasing visibility throughout the entire supply chain. Pharma companies must manage complex relationships and grapple with multi-faceted challenges in interacting with a large number of suppliers, but Palmquist feels they can better secure their products by learning from other industry models. Implementing track and trace systems into current procedures is no small task, but the FMD will demand it. She outlines how pharma could learn from the retail industry and other sectors with high-volume demand and low margins.

Getting a pharmaceutical product to where it is needed requires two aspects: delivery of the drug to the patient via the pharmacy; and delivery of the drug’s active ingredient to the site of action within the body. I have always thought that delivery by inhaled routes is intrinsically efficient – it avoids many of the difficulties of oral delivery, and can be particularly useful in juvenile and elderly patients.

This theme is taken up by Gonçalo Andrade, Peter Villax and Carla Vozone at Hovione, who explore the surge of interest in a growing market where inhaled drug delivery is reaching far beyond its origins in asthma and chronic obstructive pulmonary disease indications. Dr Paul Kippax at Malvern Instruments also discusses how dry powder inhaler (DPI) design must consider the vital role of particle characterisation in order to achieve successful formulation of products. He examines this in the context of generic DPIs and debates the role of Raman spectroscopy in this field.

May I end by wishing all our readers a happy and prosperous 2015.

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