21 CFR 11 Overview of the Final Document and its New Scope Ludwig Huber - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

21 CFR 11 Overview of the Final Document and its New Scope
Ludwig Huber
This article provides an overview of Rule 21 CFR Part 11's key requirements and its new, narrower scope.

Pharmaceutical Technology

3. International Society for Pharmaceutical Engineering (ISPE), The Good Automated Manufacturing Practices (GAMP) Guide for Validating of Automated Systems in Pharmaceutical Manufacture, GAMP4, (ISPE, Tampa, FL, 2001).

4. L. Huber, Validation of Computerized Analytical and Networked Systems, (Interpharm Press/CRC, Boca Raton, FL, 2002).

5. FDA Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Applications (Draft Feb. 2003, Final Aug. 2003). Available at http:// http://www.fda.gov/cder/guidance/5667fnl.pdf.

6. ISPE, The Good Automated Manufacturing Practices (GAMP) Guide: Risk-Based Approach to Compliant Electronic Records and Signatures, (ISPE, Tampa, FL, 2005).

7. J.C. Famulare, "Current Status and Future Directions of Part 11," paper presented Sept 21, 2004.


blog comments powered by Disqus
LCGC E-mail Newsletters

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

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
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
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 WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology,
Click here