EMA Releases Revised Computerized Systems Annex to GMP Guide - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

EMA Releases Revised Computerized Systems Annex to GMP Guide


ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Medicines Agency released Annex 11–Computerized Systems, a supplement to its GMP Guide Chapter 4 on Documentation to account for the increased use of and complexity of computerized systems in the drug-manufacturing community. The annex applies to all forms of computerized systems that are used as part of GMP-regulated activities.

Some key points in the new Annex note that computer applications should be validated and that information-technology structures should be qualified. The document also states that when moving from manual operation to computerized operation, it is important to ensure that product quality and process control assurance do not decrease. In the same regard, the overall risk to the process should not be affected when such a change takes place.

The Annex addresses risk management as a tool that should be applied throughout the life cycle of the computerized system, taking into account factors such as patient safety and data integrity. Agreements and working relationships among personnel and third parties are addressed as well. Finally, the revised Annex reviews project and operational phases of drug manufacturing and how computerized systems can play a role in these stages (e.g., by documenting validation, checking for accuracy, and maintaining audit trails).

The updated Annex will take effect June 30, 2011.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
26%
Attracting a skilled workforce
29%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
31%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here