Quality Systems

Articles

Glossary of terms

As newer and more elaborate hardware and software systems are installed in automated manufacturing environments, companies are further incorporating good practices into their validation process.

Validating Automated Systems

Analytical instrument suppliers are developing manufacturing-tailored tools that are small, precise, and easy to use.

Emerging Analytical Technology: Moving from the Lab to the Line

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

A straightforward approach reveals how the probability of passing the USP content uniformity test can be calculated for tablets and capsules.

Use of the Bergum Method and MS Excel to Determine the Probability of Passing the USP Content Uniformity Test

Ed Halpin is vice president of business development at VelQuest Corporation. EdH@velquest.com

Gordon Johnston is president of VelQuest?s European operations, The Heath Business and Technical Park, Runcorn WA7 4QF, UK. Tel. +44 1928 513 813 Fax +44 1928 513 822 Gordon.Johnston@velquest.com

 In an interview earlier this year (Bio-IT World, April 2003), Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), stated that "The original intent of the rule (21 CFR Part 11) was to facilitate the introduction of electronic technology to the process of the US Food and Drug Administration (FDA) submissions, as well as manufacturing and production. Part 11 was created to provide common-sense guidelines on how to do in the electronic world what was previously done on paper. During the last 5 years, however, confusion regarding what is included in the regulation and how to enforce it was impeding the introduction of new technology. The rule had created exactly the opposite of what was intended." 

Automated Compliance: Reducing Costs and Maintaining Quality

Robert G. Kieffer, PhD, is president of RGK Consulting.

A procedures system must be well designed and managed to be effective and efficient.

Procedures: Improving Their Quality

Lynn D. Torbeck is an international consultant and trainer specializing in applied statistics and experimental design for pharmaceutical, biopharmaceutical, and medical device research and development, validation, quality control/assurance, and production, 2000 Dempster Plaza, Evanston, IL 60202, tel. 847.424.1314.

Preventing the Practice of Testing Into Compliance

Irwin Silverstein, PhD, is vice-president and chief operating officer at International Pharmaceutical Excipients Auditing, 1655 N. Fort Myer Drive, Suite 700, Arlington, VA 22209, tel. 703.351.5266.

A new set of proposed GMP standards for excipents may present more problems than benefits.

Quality Assurance/Quality Control