Data and Artificial Intelligence

This article provides a historical review of computer validation in the pharmaceutical industry within the last three decades, evolving from the early years' initial concept and approach to today's current practices. Also included is how the regulations and industry have progressed in addressing the topic of computer validation.

Here's a look at some of the most interesting and thematic responses you-our readers-provided for Pharmaceutical Technology's anniversary survey of industry advances and directions.

Vendors who insist on using older and outdated technologies will eventually suffer increased pressure to follow the lead of those who adopt new technologies.

Brussels (May 30)-The European Federation of Pharmaceutical Industries and Associations (EFPIA) called for the pan-European and industry-wide adoption of 2-D barcode technology to combat the increase in counterfeit drugs in Europe.

Exhibitors' products prevent counterfeiting, provide child resistance, protect product quality, and improve packaging-line efficiency.

Signature authentication technology has evolved to become a stong tool for improving confidence in verification.

Dublin, OH (May 3)-In preparation for California?s new pedigree legislation, Cardinal Health plans to integrate radio frequency identification (RFID) technology into the operations at its pharmaceutical distribution center in Sacramento by fall 2007.

Interphex2007, New York, NY (Apr. 26)-Counterfeit medicines are of increasing concern to the pharmaceutical industry, both because of the potential health risks to patients and because of the effects on pharmaceutical companies' businesses. While technology such as e-pedigree and radio frequency identification (RFID) represent solutions to secure the supply chain, there are challenges.

Interphex, New York, NY (Apr. 24)-Radio-frequency identification (RFID) technology is an increasingly important tool in the pharmaceutical supply chain. Paul Rudolph of Arent Fox PLLC gave the first of several talks on RFID and e-pedigree at Interphex today in his presentation, "Pedigrees: Update on Federal and State Regulation and Effect on RFID Tagging of Products."

Billerica, MA (Apr. 13)-Millipore Corporation has become the first company to integrate radio frequency identification (RFID) technology with the filtration products used to manufacture biopharmaceutical drugs.

Washington, DC (Apr. 2)-The US Department of Homeland Security released an interim final rule that imposes federal security regulations for high-risk chemical facilities.

Missed or late calibration dates can accumulate, and even if the equipment is labelled appropriately, it can suggest poor management of resources and priorities.

Several problematic issues are associated with the development and installation of automated drug manufacturing and testing processes. The author addresses how vendors can overcome these factors to deliver robust automation across multiple sites.

Innovations in process analysis and control offer significant opportunities for improving pharmaceutical manufacturing operations

How can manufacturers improve efficiency and increase production while maintaining regulatory compliance? Process-automation solutions are one method.

New! QUMAS Introduces R&D Suite Complete with Integration and Services

The role of micro-biological testing in real-time release is too important to ignore.

It's what's on the outside that counts, too.

Brussels, Belgium (Jan. 11)-EPCglobal, the not-for-profit organization dedicated to driving global adoption of the Electronic Product Code (EPC), has ratified the electronic pedigree document specification.

Industry will be challenged to embrace new methods of supply chain collaboration.

In recent years, AI has become important in a number of fields in helping to make better use of information, increasing efficiency and enhancing productivity.

The US Food and Drug Administration has modified its requirements for drug pedigrees accompanying wholesale pharmaceutical transactions, following a US District Court preliminary injunction barring the agency from enforcing certain provisions of the rule that was to have gone into effect on Dec. 1.

Dublin, OH (Nov. 14)-A half-year Cardinal Health study of radio-frequency identification (RFID) tags "under real-world conditions has demonstrated that the technology has real promise to provide an added layer of safety," according Renard Jackson, the company's vice-president and general manager of global packaging services, in a prepared statement.

San Antonio, TX (Nov. 1)-Though the US Food and Drug Administration's final guidance on process analytical technology (PAT) was published in Sept. 2004, companies are still unsure about how exactly to implement PAT in their processes.

Outliers may provide useful information about the development and manufacturing process. Analysts use various statistical methods to evaluate outliers and to reduce their impact on the analysis. This article describes some of the more commonly used identification methods.

Large amounts of data are currently being generated in an attempt to understand and improve formulation, process, and manufacturing efficiency. This task requires novel data mining software systems tailored specifically for the formulator and process engineer.

This article examines what other industries have done to address the challenges associated with successfully implementing the principles and concepts of process analytical technology, particularly the specific elements of measurement, analysis, and control. The author explores how other industries' approaches can be applied directly to pharmaceutical manufacturing.

This article discusses the role of process simulation and scheduling tools in the development and manufacture of pharmaceutical products.

Modeling conducted in the process development and early commercialization stages can increase process efficiency and lead to process-control improvement. A virtual plant environment, running on a PC, can incorporate the same industrial control systems and configuration expertise used in manufacturing and helps many parts of process analytical technology. It also can make possible the enlightened use of technologies such as model predictive control, first-principal models, neural networks, and multivariate statistical process control.

CPhI Worldwide, Paris (Oct. 3)-Archimica, participating in its first CPhI Worldwide exhibition since being launched as new company earlier this year, outlined manufacturing expansions, technology additions, and recent projects at its facilities in the United States and Europe.