The whole package

The financial crisis and increasing regulatory restrictions make the pharma industry a tough battleground. GSK's Keith Allen tells NGP why innovative processes in the manufacturing line and ensuring regulatory harmony will create the winners in the industry.

“The regulatory bodies are causing a bit of a stir at the moment, whether it's child-resistant packaging, new track-and-trace legislation or Braille”
-Keith Allen

As Technical Manager of Packaging Technology, Keith Allen's day-to-day responsibilities require analysis of primary packaging materials and their development, ensuring that they function properly on the line. He works very closely with engineering and production to ensure that the materials used are compatible, and working with new processes such as Lean Sigma, Quality by Design and Design of Experiments.

"It's very important to get online with your engineers and experiment with the machines to understand what effects the equipment has on the material prior to any optimisation or development studies," he explains. "We perform the full validation process as well, and are getting a lot smarter with that. We're doing a lot more matrix-type testing, bracketing, especially when it comes to stability, getting the materials developed that little bit quicker and then introduced into production.

"So the manufacturing process is quite varied; we work very closely with our suppliers, mainly primary contact suppliers such as Alcan, looking at the specifications and making sure that they can meet our requirements, as well as working closely with them to reduce costs and looking at ways of standardising the materials and components.

"We've got a really good relationship with primary and secondary vendors, such as Alcan and Chesapeake. They are very good companies to work with who do supply a range of high quality products, and we've made some great progress with them in terms of cost saving and process improvements. Years ago it was all about whoever could provide the cheapest components, but now it's a strategic partnership, working with them to reduce costs and improve efficiencies."

GSK operates a number of newer processes. Allen notes that the company has Lean Six Sigma applicants, with a strong operational excellence team of green and black belts to facilitate new projects, who as a result have made strong progress, despite the recent industry hurdles set by regulatory bodies and their new guidelines.

"The regulatory bodies are causing a bit of a stir at the moment, whether it's child-resistant packaging, new track-and-trace legislation or Braille. It's interesting; it's certainly a massive challenge. For example, with the secondary packs we have to put reimbursement labels on, as well as counterfeit features, tamper evidence and Braille; combined with the new leaflet legislation it could all result in increased pack sizes. We have reduced the number of leaflets and cartons, and standardised, but the new legislation is making it more difficult. We've had to introduce more components, bigger cartons and bigger leaflets, so unfortunately we're now going the other way. It's building a lot more complexity into our process," explains Allen.

Challenges

He notes the challenges of incorporating Braille within the packaging: the height and profile of the dot and the technology that is needed in the manufacturing process either by embossing the dots during the carton manufacturing process or by screen printing on labels or cartons.

Currently the only legislation for dot height is for Italy, which stands at 130 micron; all other markets have a target height of 100 micron. "At the moment, we can achieve that, but the new guidelines are asking for possibly around 200-micron dot height, and we'd be very pushed to actually make that because you start getting a lot of bursting of the carton board, and that can affect the printed text," says Allen.

"Instead, we're looking at the possibility of labeling the packs with Braille, or reverting to a rotary type application to replace embossing, but again there is the challenge of ensuring that every single pack has the correct Braille information, and all dots are present."

Working as a global company also sets difficulties in the manufacturing process. Allen notes the trace-and-track feature and new packing lines that GSK has had to install purely for the Italian market requirements. "One of concerns right now is that we've introduced all this new technology for one market, and that other markets that also take reimbursement labels, such as France and Belgium, will require a different process, and hence different equipment.

"Ideally, if it's possible, we want one process for all markets, at least one for the EU. We're not expecting the US, Japan or possibly the Zone 4B markets to standardise, but at least we can try and do something for the EU. There must be something we can do as a pharma industry - there are a lot of influential people within it, but only time will tell if we can influence the regulatory bodies."

Allen explains that the possibility for European harmony is more likely than some of the Asia-Pacific countries, which often require additional packaging and a flow wrap, amongst other things. However, the quality of standards is not an issue that tends to greatly differ, and doesn't pose too much of a problem at present.

GSK, like every pharma company, needs to reduce costs to compete, he explains. "We need to produce more packs of high quality and with less resources. At the moment, it is working, but there is a period of continual change. Change is good, change is healthy, but we'll also need some stability. Hopefully we can get there. Changes in the ICH guidelines have affected us, but you expect that in the pharma industry, and all pharma companies should be geared up to cope with these requirements."

However, despite these worries, Allen doesn't view the future in terms of restricting regulatory constraints or the crumbling effects of the economic crisis. He talks of the innovative process, QBD, Lean Six Sigma and Design of Experiments, and the need for them in the industry. The main change, he predicts, will be outsourcing. "We're slowly getting there with the non-value adding activities, and like the asset management and maintenance I do see a lot more of that happening, but you need to retain your expertise at the sites. You can reduce head count by outsourcing, and there are lots of savings to be made, but you must have your experts; you need to retain the knowledge."

As the challenges mount across the board, it is becoming apparent that those companies with innovative R&D departments who are able to meet requirements that will continue successfully. How many companies in the industry being able to do that remains to be seen.

Keith Allen is Technical Manager of Packaging Technology at GlaxoSmithKline.

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ICH Guidelines

The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.

The purpose is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.

[Source www.ich.org]