Quality Systems

Pharmaceutical firms have every reason to feel confused and even a bit bewildered by what the US Food and Drug Administration expects from them when it comes to controlling electronic records. At times over the past nine years it has been a bit like riding a roller coaster that you weren't allowed to get off.

In 1997, the US Food and Drug Administration issued a regulation"Rule 21 CFR Part 11," that provides criteria for the acceptance of electronic records, electronic signatures, and handwritten signatures (1). FDA issued the guidance in response to requests from the industry. With this regulation, electronic records can be equivalent to paper records and handwritten signatures. The rule applies to all industry segments regulated by FDA that include good laboratory practice, good clinical practice, and current good manufacturing practice.

Paper notebooks are the accepted method for recording laboratory data and the ideas generated from that information in the pharmaceutical, biotech, and chemical industries. Nonetheless, the revolution in digital data processing has improved the way data is created, organized, and managed electronically, whether in the form of analytical data, images, documents, or multimedia files. The preservation of such information into a digital form offers the potential for online storage and retrieval, efficient search processes, and worldwide data transmission.

New Excipient Guidance Doesn?t Fill Regulatory Gap

Recalls, Resignations, and Suspended Manufacturing Plague Able Labs

FDA Drug Safety Oversight Board

FDA

Bedford Recall

Pharmaceutical science and technology news.

FDA is finalizing guidances and enforcing compliance with manufacturing standards as part of its efforts to ensure drug safety.

The FDA initiative —Process Analytical Technologies (PAT) — is slowly gaining momentum, creating a revolution in manufacturing and testing processes that aims to ensure product quality. Its growth will encourage faster testing techniques to bring analytical testing closer to on- and at-line testing during the product manufacturing process.

While Europe's political leaders were paying lip-service to creating a more competitive Europe at their spring summit in Brussels, European pharmaceutical technologists were tackling the serious business of turning political rhetoric into practical reality.

Study results show that the state of a cleanroom clothing system–new or much used–influences the protection efficacy of the system.

Pfizer Recalls Lot of Neurontin

Drug Recall

HHS Awards $97-Million Vaccine Development Contract

Warning Letter: Compounding at Palace Pharmacy

Pharmaceutical Science and Technology News

Managers of FDA-regulated firms must be proactive in how they manage their company?s compliance with good manufacturing practices regulations.

The C-SOC team must develop a network of committed industrial partners who will participate in the direction, execution, and evaluation of research and educational activities.

An increasing number of new compounds are being introduced into pharmaceutical pilot plants.The knowledge base for these compounds regarding their toxicities,physical handling, and cleaning is limited.The authors examine various approaches for addressing the cleaning validation of new compounds and discuss the role of determining appropriate visible residue limits.

At its 2005 Convention, USP passed 13 resolutions that will help define the organization’s path for the next five years and represent the interests of its diverse constituency.

Innovators and generics makers are staking out positions on follow-on proteins and other manufacturing issues.

Managers of FDA-regulated firms must be proactive in how they manage their company's compliance with good manufacturing practices regulations.

The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results. To properly validate these alternatives, a practitioner must first identify what is being studied. The regulatory effect on established product and process specifications and levels must be completely evaluated, as changing the method of analysis may well change the apparent number in the sample.

FDA Finalizes Guidances on Minimizing Drug Risk and Submitting Pharmacogenomic Data

FDA New Drug Review Times Continue to Drop in 2004

USP to Publish Spanish Translation of USP-NF; Council of Experts Named

Warning Letters: DanChem Technologies & Medsep

US Marshals Seize Supplies of GSK Paxil CR, Avandamet