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There are vast amounts of knowledge available to assist healthcare facilities, including hospitals, to prepare for and respond to hazards associated with weapons of mass destruction, and other large-scale emergencies. Despite the existence of numerous guidelines and policy documents designed to support hospital preparedness, a medically/environmentally driven definition of “minimal levels” of preparedness is presently lacking.

A group of agencies began work on the hospital preparedness issue as an element of regional planning for a variety of major events. Weaknesses were uncovered in the hospitals’ plans to manage major casualty incidents, particularly those involving hazardous substances. This group did significant development work in the year prior to the development of the ASTM task group. The groups that participated in that activity included the Texas Department of Health, the Agency for Toxic Substances and Disease Registry, the Federal Emergency Management Agency, the Environmental Protection Agency, the Joint Commission on Accreditation of Healthcare Organizations, the State of California Emergency Medical Services Authority, and the Hospital Resources Services Administration, including its border health offices.

In December 2003, the task group expanded its original vision and requested participation within ASTM International. As a result, the E54.02.01 Task Group on Hospital Preparedness was officially organized in February 2004, and after the exchange of several electronic drafts of hospital preparedness concepts, the group met in Atlanta, Ga., for an intense work session in early March 2004. That meeting clarified a series of major content items, and officially established several working groups to concentrate on those areas. The initial ballot of the hospital preparedness standard was issued on April 14, 2004. After several additional ballots and meetings, the standard E 2413, Guide for Hospital Preparedness and Response, was approved on Nov. 1, 2004, and is the first approved standard for Committee E54 on Homeland Security Applications.

A New Technical Committee:
E55 on Pharmaceutical Application of Process Analytical Technology

For decades, the global pharmaceutical industry and the U.S. Food and Drug Administration accepted the fact that even as new drugs are invented, the process and techniques for manufacturing those drugs lag far behind those employed by related industries. Even faced with large numbers of drug recalls (176 in 1998, 248 in 2001, and 354 in 2002), this inconsistency was the status quo. The FDA, charged with protecting the safety of consumers, felt it more important to manufacture using an established protocol than to investigate and possibly take advantage of newer, more sophisticated manufacturing models. The industry, with billions of dollars of revenue at its disposal, had a greater financial incentive to invest these dollars in locating, evolving, and marketing new drugs than in re-tooling existing manufacturing processes, equipment, and methodology.

Faced with the inevitable conclusion that the pharmaceutical industry was in drastic need of new and innovative process improvements, the FDA (for the first time in over 25 years) overhauled its regulations governing drug manufacturing. The FDA’s draft guidance for the industry, PAT — A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, was the first step in facilitating the development, implementation, and regulation of manufacturing processes based on fundamental process understanding.

The need has now evolved to defining and developing a series of process-based (rather than product-based) “best practices” to advance the scientific approach to addressing process knowledge and flexible manufacturing. The FDA has encouraged the pharmaceutical industry to take an active role in identifying and drafting such practices for one fundamental reason — if the FDA were to solely develop such practices, the experience and expertise in the pharmaceutical industry could not be engaged to the level desired. Thus, the aim was to gather broad representation from the pharmaceutical industry, identify appropriate topics for discussion, and create an appropriate structure for drafting a series of consensus standards.

The FDA has stated that these collaborations will lend credence and general acceptance to the practices that are developed, as well as establish the foundation for the implementation and regulation of process analytical technology. Finally, the early implementation of a series of process-oriented standards would lead to a greater understanding of the variables associated with product performance, which would (in turn) help create consistency, thereby lowering production expense.

In response to the market conditions described above, the FDA’s Center for Drug Evaluation and Research contacted ASTM in December 2002, with a request for a briefing and orientation to the ASTM process. In July 2003, ASTM again met with FDA representatives to discuss the possible development of an industry-driven consensus standards program capable of reaching a truly global audience. That meeting resulted in a request (by the FDA) for ASTM to hold a planning meeting of a select group of key industry stakeholders to discuss the need for standards in the area of process improvement and control.

At a planning meeting held Oct. 3, 2003, at ASTM International Headquarters, key members of the pharmaceutical industry, including multi-national manufacturers and users, and the FDA unanimously agreed to hold an organizational meeting for the development of this new activity within ASTM International. Various disciplines, including consumers, manufacturers, suppliers, trade and professional societies, and federal agencies were invited to participate. The attendees at the planning meeting also recognized the need to evolve their manufacturing processes to be more consistent, efficient, and cost-effective.

At an organizational meeting held Dec. 1-2, 2003, at ASTM International Headquarters, over 60 representatives of the pharmaceutical industry voted to organize such an activity within ASTM — the result of which was Committee E55 on Pharmaceutical Application of Process Analytical Technology. To date, Committee E55 hosts 175 members from 12 countries and has developed E 2363, Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry.

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