Keeping Pharmaceutical Manufacturing in Check

Dirk Bettels
Senior Product Manager
Mettler-Toledo Garvens

Dirk Bettels, Senior Product Manager of Mettler-Toledo Garvens spoke with Mahesh Kallayil on the challenges faced by the pharmaceutical industry in ensuring quality control and how checkweigher connectivity and serialisation technology can help pharmaceutical manufacturers adapt to the dynamic regulatory landscape. Edited excerpts from the interview.

The pharmaceutical industry is, as ever, a resilient sector of the global economy, but it too has faced its fair share of challenges in recent years. Costly product recalls, spurious counterfeit drugs, and changing regulatory landscapes are the key challenges faced by manufacturers worldwide from emerging Asian hubs such as China and India to the US.

These challenges have redoubled demand from pharmaceutical manufacturers for highly advanced integrated product inspections systems capable of upholding product safety and quality while boosting line efficiency to meet global consumer demand. For a growing number of manufacturers, it is essential to find ways of centralising data collection from their product inspection equipment and monitor performance across multiple manufacturing facilities in real time to not only meet strict internal quality assurance standards resulting from increasing quality awareness, but also comply with stringent legal requirements from national and international regulatory bodies.

Market Factors Affecting Innovation in Checkweighing and Serialisation Technologies

Stringent regulations have been put in place worldwide in recent years to curb the growing menace of counterfeit drugs. In addition, pharmaceutical manufacturers are under pressure to ensure product safety in their production processes and supply chain from the sourcing of raw ingredients to the transport of finished products to end users.

Manufacturers operating in multiple international markets must contend with changing regulations as well as regional and geographical variations in pharmaceutical safety standards. Requirements concerning the marking and serial number verification for pharmaceutical products, the display of weight, net content and the maximum permitted variation in the net value of content in packs vary from region to region. Manufacturers need to be aware of relevant regulatory standards not only in countries where they operate but also where they export to protect consumers against counterfeit pharmaceutical drugs entering the marketplace.

In the US, on the November 27, 2013, the Public Law 113-54, referred to also as Drug Supply Chain Security Act (DSCSA) was made law. This document established new federal requirements for traceability, with penalties for breach of legislation. Currently pharmaceutical companies are required to share transaction information of prescription drugs, extending to full serialisation information in 2017 and traceability documentation about the entire supply chain in 2023.

Manufacturers looking to trade in Germany and in other EU countries will have to ensure they meet the requirements of the new EU Directive on Falsified Medicines. Due to come into force in 2018, the directive stipulates that serialisation be undertaken for all pharmaceutical products sold in the region to enable them to be traced to their point of origin and ensure consumer safety. Manufacturers will face similar requirements when exporting to Brazil and Saudi Arabia, both of which have serialisation legislation due to come into force in 2016. Russia too is enacting legislation to enhance safety across the pharmaceutical supply chain.

Indian manufacturers exporting products overseas must adhere to the country's 2011-2012 Directorate General of Foreign Trade (DGFT) requirements for serialisation on pharmaceutical packages exported from India. According to Directorate General of Foreign Trade (DGFT) Public Notice No. 21 issued in January 2011, it is mandatory for Indian exporters of pharmaceutical products to label unique numbers and bar codes, encoding GTIN, serial number , batch number, and expiry date, on tertiary, secondary and primary level packaging. Pharmaceutical manufacturers need to gain control over marking and verification of serial numbers on products to comply with various regulatory requirements at each step of the manufacturing process so that products can be identified back to the producer, preventing end users from potentially harmful and fatal counterfeiting products. It is also essential to ensure full traceability throughout the supply chain which requires high level of system integration and efficient data management capabilities. A networked, consolidated checkweigher and serialisation solution installed on a production line and connected to a centralised data collection system can help manufacturers monitor product inspection data in real-time from multiple locations. It provides an at-a-glance window into their operations, enabling immediate identification and resolution of problems that occur along a production line to minimise production downtime.

Challenges in Implementing Connectivity Solutions

Many pharmaceutical manufacturers fear that networking product inspection technology on a processing line will be timeconsuming and require production downtime. However, working with an experienced and knowledgeable product inspection equipment provider can streamline the connectivity process and minimise any necessary downtime. The gains in line efficiency that can result from enhanced product inspection connectivity have the potential to outweigh any initial expenditure.

Another challenge for manufacturers is data security. As with any networked application, companies must guard against potential hacking. A growing number of product inspection equipment suppliers are developing data collection solutions that enable manufacturers to connect geographically isolated processing lines to a centralised location while maximising data security. This allows manufacturers to benefit from optimised system connectivity without compromising the security of their product inspection records.

Benefits of Linking Product Inspection Systems

There are a number of benefits to networking the product inspection systems on a processing line. By enabling all product inspection data to be accessed from one centralised Human Machine Interface (HMI), a supervisor can successfully monitor performance across the entire processing line in real time. This makes it possible to immediately identify any adverse trends in, for example portion control in the packaging line, or a machine that is in need of maintenance anywhere along the line. Supervisors can be proactive rather than reactive in undertaking corrective actions so that line disruptions can be handled and resolved quickly and with minimal downtime. Centralised data collection can save an enormous amount of labour as fewer personnel are needed to manually collect data from individual machines. Data is instead collected online, minimising time and reducing the possibility of human error.

By gathering detailed information about the performance of the packaging line from checkweighers, for example, connectivity solutions can be used by manufacturers to reduce wasteful product giveaway, such as overfilled cream in a tube or powder in a box; as well as minimise instances of underfilled packages that do not comply with metrology legislation, such as the European Measuring Instruments Directive (MID), avoiding costly product recalls.

What is more, an integrated product inspection system boosts product traceability, enabling manufacturers to protect themselves and their consumers from counterfeit drugs and demonstrate due diligence in the event of a safety incident. Moreover, in case of product recall an integrated database helps identify and tracks the specific defective product batch thereby eliminating the necessity of recalling the entire shipment.

Connectivity Options for Pharmaceutical Manufacturers

There are a number of highly sophisticated software solutions available for management and control for all track and trace lines. These programmes enable connectivity and integration of checkweighing, metal detection and x -ray inspection devices within a production line to give an at-aglance, holistic overview of the entire processing line by providing central user and access management. Other connectivity options include interface modules and object linking and embedding servers for process control. These linking technologies enable automatic communication between product inspection machinery and therefore provide a more accurate and extensive overview of the processing line.

With each of these solutions, valuable information such as mean value charts and product reject reports can be accessed and produced easily, facilitating data monitoring. If the manufacturer has a PC or PC network available, data interfaces can be installed to deliver weight data and serialisation details directly to a centralised computer. Remote HMIs enable processors to interface with checkweighers to deliver statistics to optimise production management and facilitate product changeovers to enhance production line flexibility.

Future of Connectivity for Checkweighing Systems

More and more checkweighers will include features that enable them to be networked to pharmaceutical manufacturers’ data collection solutions. On -going market pressures, such as the increase in the cost of raw materials, are making such solutions desirable to pharmaceutical manufacturers - and legislation requiring enhanced traceability due to be introduced over the next few years will make it a necessity. Checkweighing system suppliers are working to ensure their technology continues to help manufacturers comply with regulations and enhance efficiency well into the future.