In addition to automation standards, regulatory concerns arose involving system management, production automation, and the
data being created. In response to the uncertainty about validating computer systems, end users, automation vendors, and consultants
collaborated to define and standardize practices. In 1994, the Parenteral Drug Association (PDA) issued Technical Report 18: Validation of Computer-Related Systems. In 1995, the Good Automated Manufacturing Practice (GAMP) Forum issued The GAMP Guide for Validation of Automated Systems in Pharmaceutical Manufacture. GAMP became the user community's forum for comments and responses to governmental regulations. Also, PDA issued Technical Report 32 to define good practices for auditing suppliers. Although 21 CFR Part 11 was not formally issued until 1997, it had begun to be developed in the early 1990s. Part 11 focused on how to design,
implement, test, and manage change with automation systems and the electronic data created. By the late 1990s, the focus had
clearly begun to shift from applying technology to managing records and demonstrating regulatory compliance.
Milestone. 30 Years of Pharmaceutical Technology
The late 1990s and early 2000s
The standardization movement gained momentum with the advent of the new century. Life-sciences companies built upon trends
from the early 1990s by using distributed hardware and putting Ethernet-enabled input–ouptut in the field. These measures
were followed into the field by controllers and their cabinets as centralized rack rooms were superseded. Yet, life-science
companies proved quite conservative when it came to adopting the digital field buses that were becoming common in other industries.
These companies are only now moving in this direction.
Life-science industry users also accelerated their demand for standardized, configurable, OTS equipment. They also began demanding
standardized connections between software applications. In the real-time world, standards such as Ole for Process Control
(OPC) became the accepted means to share data between plant-floor applications.
Yet more real-time connectivity for batch information was needed, so the industry participated in the development of the S95
standard to help define connections between applications such as enterprise-resource planning and plant-floor automation systems
(e.g., DCS) to make batch execution and recipe management more effective. Recipe- and materials-management applications, their
interaction, and their connectivity were key for life-science users.
The regulatory burden peaked at the turn of the century. Restrictive audit findings by FDA (which increased the burden of
rules already on the books) and the more general year-2000 computer issues led life-science companies to focus on meeting
regulations, not on improving manufacturing. Companies used GAMP and other industry avenues to warn regulatory bodies of their
Regulations such as Part 11, however, also drove the life-science industry to move to the forefront in some areas. Today,
life-science companies are ahead of chemical and other industries on the issues of data security, record security, lot tracking,
and batch management in general. Not only did fear of Part 11 enforcement inspire the industry to take action, but the regulation's
focus on electronic data and record issues caused companies to reevaluate and modify their systems even when enforcement lessened.
Also, life-sciences vendors were motivated to improve product features for electronic data and records.
In response to the industry's concerns, FDA released its report titled Pharmaceutical CGMPs for the 21st Century—A Risk-Based Approach in 2004. FDA's new policy allowed life-science companies to be innovative and to apply risk-based technology approaches to
improve manufacturing. As a result, the adoption of digital buses, advanced control technology such as neural nets and multivariable
process control, and embedded in-line analytical analysis is becoming widespread.
Further extensions of the standards movement include completely modularized plant construction and the accelerated use of
standardized skid-mounted equipment. These changes made the construction process faster. Combined with the spread of standards
and class-based approaches, they have had a significant effect on automation and technology. Standardized process equipment
spurred the use of commercial, OTS hardware for networking, computing, and user interfacing. This hardware makes support easier
to deliver and accelerates the technology change life-science companies face.