Articles by Angie Drakulich - Pharmaceutical Technology

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Articles by Angie Drakulich

EMA Releases Revised Computerized Systems Annex to GMP Guide

Feb 3, 2011

The European Medicines Agency has released a new Annex 11-Computerized Systems 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.

Real Time Release Testing: Analytical Methods and Innovations

A roundtable moderated by Angie Drakulich.
Feb 2, 2011

A roundtable moderated by Angie Drakulich.

Global Healthcare on the Ground: USP

USP helps to improve drug quality in 32 countries.
Feb 2, 2011

USP helps to improve drug quality in 32 countries.

Real Time Release Testing

Industry and regulatory experts discuss the challenges and benefits of implementing real time release testing in a pharmaceutical manufacturing environment.
Feb 2, 2011

Industry and regulatory experts discuss the challenges and benefits of implementing real time release testing in a pharmaceutical manufacturing environment.

Strategies for Becoming a Preferred Provider

A contract-service provider roundtable, featuring Albemarle, Baxter, DPT, Pfizer CentreSource, Dr. Reddy's, SAFC, and Vetter. Read this and other preferred organization articles in this special issue.
Feb 1, 2011

A contract-service provider roundtable, featuring Albemarle, Baxter, DPT, Pfizer CentreSource, Dr. Reddy's, SAFC, and Vetter. Read this and other preferred organization articles in this special issue.

Draft Guidance Issued on Capsule Bead Size

Jan 20, 2011

FDA issued a draft guidance for industry on Jan. 18, 2011, about the size of beads within drug products labeled for sprinkle.

FDA Launches Industry Basics Website

Jan 13, 2011

As part of its transparency initiative, which began in June 2009, FDA launched a website during the first week of January 2011 that addresses basic questions for industry about regulated products.

FDA Discusses Current and Future Take on Compliance

Jan 2, 2011

Industry executives share insight into the future direction of drug manufacturing and the supply chain.

Preventing and Troubleshooting Manufacturing Deviations

Industry experts offer their best practices for dealing with deviations. This article contains online bonus material.
Jan 2, 2011

Industry experts offer their best practices for dealing with deviations. This article contains online bonus material.

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