Pharmaceutical Industry’s Transition from Paper-Based to Electronic Processes.
The advantages to pharmaceutical companies of using electronic solutions to modernize their paper-based or partially electronic processes are enormous. Automation speeds up and connects all interrelated processes (CAPA, customer complaints, audits, deviation management, change control, training, purchasing, etc.). This eliminates errors due to human oversight and ensures FDA compliance, which requires that strenuous controls be in place for ensuring the identity, strength, quality, and purity of drugs (Section 211.100).
Automated solutions expedite communication with support service companies, external partnerships, and vendors. They reduce the time that must be spent in meetings by providing instant access to the most current data and information available. With a web-based system, current data and information can be accessed from virtually any location in the world. Automated solutions also help keep executive management well informed by providing access to all company activities, 24-hours a day. This enhances compliance and helps ensure smooth operations. With some systems, managers and other authorized users can even view critical path workflows in real time to help avoid potential bottlenecks.
Moreover, companies that automate their processes accelerate the development of new products and reduce the time-to-market for products currently under development.
The FDA’s Campaign to Encourage the Transition
The FDA’s campaign to encourage all pharmaceutical companies to modernize their paper-based (or partially electronic) processes is believed to be due to the slowdown in the availability of innovative medical products. According to one ongoing study, the cost and time of bringing a drug to market jumped from $231 million and 8-10 years in 1990, to $802 million and 10-12 years in 2001, to the current estimate of more than $1 billion and 12-14 years.1 The reason for this increase is thought to be the combined result of increased federal regulation and inefficiencies throughout the product development process.
In August 2002, the FDA launched a 2-year initiative, titled Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach (also known as the Pharmaceutical cGMP initiative). Among the objectives put forward, the first was “to encourage the early adoption of new technological advances by the pharmaceutical industry.”2
Only 5 months later, in January 2003, the FDA launched another, similar initiative—this one directed at all life science companies. The express purpose of the Process Analytical Technologies (or PAT) initiative was “to help make innovative medical technologies available sooner, and to reduce the costs of developing safe and effective medical products while maintaining the FDA's traditional high standards of consumer protection.”3
In October 2004, the Acting Commissioner of the FDA, Lester M. Crawford, had this to say in a speech he made before the R&D Leaders' Forum:
The GMP overhaul, which is catching up with almost 25 years-worth of scientific and technological developments affecting drug manufacture, is now nearing completion. The measures we've adopted incorporate risk-based principles, science-based policies and standards, and integrated quality systems, and are meant to encourage drug firms to modernize their manufacturing processes. We hope that these innovations will lower the production costs and increase the availability of more affordable medications, and thereby strengthen the public health. [Italics inserted].4
Managing the Process of Moving Forward
Perhaps the main reason that some (particularly small-to-midsized) pharmaceutical companies may be reluctant to automate their processes is because, given the complexity of their operations, the idea of changing to an electronic system seems a bit overwhelming. The process of moving forward can be more easily managed if companies:
- Develop a team of experts within the company from the areas most involved with regulatory documents—for example, product development, manufacturing, regulatory and quality—and create a short list of document control system “must have’s.”
- Bring an affordable, easy-to-learn, out-of-the-box document control system online early in the development process and start growing the company’s acumen as the product moves through the development phases. This helps build the submission.
- For companies with products already being manufactured, start at either end and work towards the middle. Incorporate the document control system in manufacturing and distribution immediately, and use the system to track early stage products at the same time.
When companies start to feel more comfortable, they can start using the system for training, to create email alerts, and for regular, periodic internal audits. By getting personnel used to using the system, they will soon grasp its power.
1 Tufts Center for the Study of Drug Development. (Ongoing study). Retrieved
September 12, 2007 from http://csdd.tufts.edu/Research/Milestones.asp.
2 FDA Center for Drug Evaluation and Research. (2003, February). Pharmaceutical cGMPS for the 21st Century — A Risk-Based Approach: Second Progress Report and Implementation Plan. Retrieved October 28, 2007, from http://www.fda.gov/cder/gmp/2ndProgressRept_Plan.htm .
3 FDA News Release, Department of Health and Human Services. (2003, January). Retrieved December 31 from http://www.fda.gov/bbs/topics/NEWS/2003/NEW00867.html .
4 Crawford, L.M. (2004, October). Speech before R&D Leaders’ Forum. FDA US Department of Health and Human Services. http://www.fda.gov/oc/speeches/2004/leaders1005.html .
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