Challenges of pharmaceutical regulation
According to pharmaceutical industry experts, IMS Health, in 2011, the global pharmaceutical market was worth $880 billion, growing at 5-7% per year. Accountants Pricewaterhousecoopers (PWC) forecast a golden era for the global pharmaceutical industry, expecting it to be worth nearly $1.6 trillion by 2020. Currently, the US tops the list of global pharmaceutical markets with industry experts predicting 33% growth to $476 billion in the same period, thanks to the Affordable Care Act. However, emerging markets, including China and Brazil, are taking great strides forward and now boast the 3rd and 6th largest pharmaceutical markets in the world.
Amid a wave of expiring patents on some of the industry’s most successful branded drugs and medicines and growing competition from cheaper generic drugs, pharmaceutical manufacturers are likely to see “minimal growth in their branded products up to 2016”, according to IMS health. The global generic drug market is worth US$225 billion and will continue to grow at 10% Compound Annual Growth Rate (CAGR) to US$358 billion in the next five years, according to according to a BCC Research report. However, this strong growth in the generic drugs market is threatened potentially from counterfeit medicine.
The counterfeit drug market is growing rapidly and accountants Deloitte currently value it between $75 billion to $200 billion. The World Health Organisation (WHO) believes that over 25% of medicines available in developing countries and 50% of products ordered online are counterfeit. The institute estimates that 100,000 people in Africa lose their lives each year due to counterfeit medication. In response, governments across the globe are beginning to tighten up pharmaceutical regulations, making traceability an obligation for the industry.
However, in the absence of a single international regulatory body, the pharmaceutical industry is finding it difficult to curb the counterfeiting menace. Recognising this problem, the US and Europe are leading global efforts to establish a comprehensive drug traceability framework. France, Italy, Greece, Belgium and Turkey have already adopted traceability regulations and other European governments are expected to produce similar legislation.
Advanced product inspection technology, including track and trace systems, checkweighers, metal detectors and x-ray equipment, is being seen in the industry as the answer to enhancing the traceability of pharmaceutical products through the supply chain and to optimising product quality and safety. The use of such technology can help protect the consumer from substandard medicines and guarantee the reputation of the pharmaceutical brand.
Keeping track of your line
Globalisation has made the pharmaceutical industry procurement and supply chain more complex than ever before. Today, raw materials are often sourced in one country, processed in another, with the finished product being sold in a third. This complicated supply chain has only increased the importance of track and trace technology on pharmaceutical processing lines to enable manufacturers to demonstrate compliance with relevant safety regulations throughout its operations.
The European Union (EU) Directive on Falsified Medicines, which will come into effect in 2015, will require pharmaceutical manufacturers to introduce advanced serialisation technology on their lines. The Directive aims to facilitate traceability of pharmaceutical products and protect consumers from the entry of counterfeit drugs on the market. Turkey has led the world in this area so far, introducing the Ilac Takip Sistemi (ITS) drug tracking system as early as 2010 to combat a drug counterfeiting epidemic in the country. France, Italy, Greece, and Belgium have since adopted their own traceability regulations ahead of the EU Directive and it is likely that concerns about drug safety among consumers in the region may push other EU nations to adopt similar frameworks. Developed and emerging economies elsewhere in the world are expected to follow the same route in the near future.
Advanced serialisation and vision inspection systems allow manufacturers to track their products through the production line from individual cartons to bundling to palletisation through to delivery. It is even possible to track individual pills as they progress through the production line. Such technology is also capable of examining packaging for the correct product identification (ID) number and bar code. As barcoding can be susceptible to print faults, immediate and reliable detection of faulty codes for fast moving pharmaceutical production lines is imperative to minimise the risk of product recalls due to non-compliant labelling, protecting profits and upholding brand reputation.
Safety first
Pharmaceutical safety is not just about the active ingredient. There are additional issues that must be addressed to safeguard consumers, such as ensuring that products are free from foreign body contamination. The principal contaminant threat on a pharmaceutical production line is from broken sieve wire, which can enter the product flow during the processing of the raw ingredients that make up the final caplets or tablets.
Metal detectors able to identify contamination from ferrous, non-ferrous and non-magnetic stainless steel fragments are ideal for inspecting pharmaceutical products. Thanks to the advancements in technology, metal detectors are more sensitive than ever before and are now capable of overcoming the “orientation effect” – the phenomenon whereby metal fragments are easier to identify in one orientation relative to the metal detector search head than another. Pharmaceutical metal detectors can be used to inspect tablets, capsules and pharmaceutical powders, helping to ensure compliance with regulatory requirements.
Question of quality
Other product quality parameters are also key to ensuring safety for consumers. Pharmaceutical manufacturers must inspect their products for seal integrity to ensure product sterility and minimize the risk of product tampering. They must examine their packaged products for broken vials and missing caplets and ensure the presence of Patient Information Leaflets (PILs), which in many countries are a legal requirement. Manufacturers should monitor the fill-level of their packs as well. This can help minimise the instance of wasteful product giveaway, enhancing production line efficiency.
X-ray inspection systems can identify contamination from foreign bodies including metal and glass fragments, high-density plastics and rubber. The technology can easily examine products for seal integrity, identify broken and missing components, measure product mass and check fill levels. Checkweighing systems are capable of inspecting fill level of bottles and vials for portion control, boosting efficiency of lines manufacturing single-use products, reducing product waste for manufacturers and safeguarding consumers against inaccurate dosages.
Extending your reach
With the largest pharmaceutical companies operating in multiple locations worldwide, many are producing their products locally to ensure that they comply with the relevant local regulations. To reduce production costs, while upholding product quality and safety, manufacturers can harmonize their processing systems by sourcing the product inspection technology used on all of their manufacturing lines from the same supplier. Connecting product inspection equipment across multiple production lines to a single data collection network can facilitate monitoring of performance records, giving manufacturers greater control over global product quality for the demonstration of due diligence.
There are many options available for product inspection systems in the market but sourcing them from global manufacturers ensures the same standard and quality technology is used on every production line. With advancements in technology, inspection systems have become more compact, simpler to use and easier to integrate with other systems on the production line than ever before. Innovative product inspection software enables every machine to connect to a data collection network, allowing all product inspection records to be stored in one central location, facilitating tracking of product batches for manufacturers and, in the event of product recall, streamlining the identification of problem batches and corrective procedures.
Staying ahead of the pack
In the next few years, in light of changes in the regulatory landscape and the globalisation of pharmaceutical production, more and more pharmaceutical manufacturers will turn to product inspection solutions to automate their inspection processes. Not only can the use of such technology enable manufacturers to uphold product quality, but it can also help in significantly reducing manufacturing costs.
It is important the pharmaceutical manufacturers work in partnership with product inspection system suppliers to select the product inspection equipment best suited to the needs of their product and their production line. In this way, manufacturers will be able to face up to industry changes in regulation well into the future.