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
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
27%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
8%
All of the above.
46%
No government involvement in patient treatment or drug development.
7%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here