Technological Developments

Introduction

This paper will focus on the technological developments that are driving the pharmaceutical industry. Governmental oversight imposed by the Food and Drug Administration requires strict accountability and quality control. We will look to the fast food industry for best practices considering the FDA also regulates this industry as well. A repeatable and auditable system of production, operation, and distribution will be the cornerstones of the technology employed.

Pharmaceutical Industry

The pharmaceutical industry is a highly regulated industry that is subject to continuous audits and monitoring form the government. The regulatory oversight to assure that the drug products meet the identity, strength, quality, and purity regulations begins with manufacturing of the investigational drug for its first use in human subjects and continues through the shelf life of the product (Velagaleti, Burns & Gill, 2003). Automation is one of the tools being used by the industry to minimize costs while complying with these regulations. In the beginning the Food and Drug Administration, FDA, government agency that regulates the industry, was very concerned on the effect that automation and cost reduction could have on the final product. This led to the review of the Code of Federal Regulations to regulate how to automate processes. The industry has invested a great deal of effort in demonstrating that automation, if handled correctly, does not jeopardize the final product or the consumers’ safety.

Complying with the regulations and fully automating requires an interaction between the SCADA, PLC, network, databases, servers and reporting tools. Supervisory Control and Data Acquisition (SCADA), as the name indicates, is not a full control system, but rather focuses on the supervisory level. As such, SCADA is a purely software package that is positioned on top of hardware to which it is interfaced, in general via Programmable Logic Controllers (PLCs) (Danees & Salter, 2003). The interface is done through networks and data is saved in databases that reside on the equipments computer or on servers. Reporting tools are configured to obtain this data and prepare reports according to the process needs. Human interaction with control systems are monitored through Audit Trails that identify who and what is performed on the system. The reports and signatures are governed by Title 21, Part 11 of the Code of Federal Regulations (21 CFR Part 11), which is almost always the start point of an audit of control systems.

The FDA has accepted with time automation of the processes and is now leading to an even higher level of automation with the implementation of Manufacturing Execution Systems (MES). In a study performed by Vijavan (2000) it was stated that among the advantages of MES is the fact that help deliver information from the factory floor to plant managers in real time. This information facilitates the planning, monitoring of inventory and flow of information from the shop floor to management. This system can substitute paper records with electronic records, integrate the equipments to the electronic records and monitor the training of the personnel performing the activities. If implemented correctly, a MES can manage, initiate, respond to and report on each of the primary production activities of a plant (Vijavan 2000), which will result on a faster response to process deviations.

The main challenge of implementing a MES into an enterprise system is that it requires very tight integration between systems that are as varied as order entry systems, product configurations and planning and control systems as well as sales force and delivery systems (Vijavan 2000). Implementing the system in an environment that is fully automated has demonstrated to be very costly and dangerous because of the incompatibility of the applications. For this reason many industries are opting for partial implementation on this environments and a full implementation on new processes or processes that will be automated.

The assurance of the state of control during manufacturing is accomplished not only through appropriate procedures and documentation of various steps during all phases of manufacturing and packaging but also through monitoring quality at various steps by performing various analytical tests (Velagaleti et. all, 2003). Process Analytical Technology (PAT) is a system for designing, analyzing, and controlling manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality (PAT Initiative, 2005). Contrary to automation, PAT has the government blessing and the FDA has a committee responsible for facilitating the implementation of the technology.

The technology does not impact directly the process and is not considered automation. It is a series of sensors, mostly near infrared sensors (NIR) that generate different signals through the process. These signals are studied and compared to the process until a relation between the signals and the products analytical composition can be determined. As with MES this technology does not necessarily integrate with current systems or applications currently operating in the organizations and remediation of the systems are required for its implementation. Studies performed as part of the initiative have presented more failures than successes, but the benefits of the successes are such that the industry is willing to continue experimenting until fully implementing the technology. Success results in an unimaginable understanding of the process that will result in new more effective ways to manufacture medicines and products.

Best Practices In the Fast food Industry

Technology has not only been a leveraging tool in the pharmaceutical industry, but also the fast food industry. McDonalds is a successful fast-food chain that relies on technology to evaluate the company’s supplier of hamburgers. The supplier is evaluated according to McDonald’s best practices of cleanliness, consistency, and trace-ability. According to the article:

When Swedish supplier Farlo was founded a decade ago for the purpose of making McDonald’s hamburgers, the company required a means of satisfying those criteria while meeting a production load of 1 million hamburgers per day. While Farlo’s overall goal was to improve production quality and capacity by streamlining and integrating plant monitoring and business systems, it also needed to document the quality and trace-ability of each item producedвЂ"practices that proved costly and inefficient when performed manually (2001).

By implementing the Supervisory Control and