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The New USP <1231>
Water for Pharmaceutical Purposes

a detailed Overview

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GMP LOGFILE Features

2016-08-23

Separate Device Specification for the FDA?
Your question - our answer

by Thomas Peither

 
2016-08-03

Don’t Be a Daredevil When Retrofitting Your Facility

by Bob Ferer

 
2016-07-20

Roadmap to Manage Personnel in Pharmaceutical Manufacturing

GMP Series PDF Download

An excerpt from the GMP MANUAL

by Michael Hiob

 
2016-07-12

What typical situations must be controlled by a quality management system?

An excerpt from GMP Fundamentals

by Dr. Christine Oechslein

 
2016-07-06

Basic Principles of a Document Management System (DMS)

Excerpt from the GMP Series pdf download
Successful Implementation of Electronic Document Management Systems


by Markus Roemer

 
2016-06-29

Change Control – Dealing with Changes in Investigational Medicinal Products

by Kerstin Kruithoff-Ley

 
2016-06-22

System types by extent of automation

Excerpt from the GMP Series pdf download Electronic Batch Recording for Drugmakers


by Markus Roemer

 
2016-06-15

Overview of the New USP <1231>
Water for Pharmaceutical Purposes

by Fritz Röder

 
2016-06-01

Qualification of Single-Use Component:
The Need for Standardization

by Christopher Smalley

 
2016-05-25

Quality Metrics – Bane or Boon?

GMP Talk with Experts Claudia Pachl and Ruven Brandes

by Dr. Sabine Paris

 
2016-05-13

Microbiological monitoring of cleanrooms – regulatory requirements

Excerpt from the GMP Series pdf download Monitoring of HVAC Systems in GMP Environments

by Dr. Hans H. Schicht

 
2016-05-09

Problems with the Regulatory Culture

by Robert G. Kieffer, Ph.D.

 
2016-05-04

Air cleanliness grades and associated process steps

Excerpt from the GMP Series pdf download Classes and Grades for Air Cleanliness

by Dr. Hans H. Schicht

 
2016-04-25

Work instructions, records and documentation –
How do you keep track?

An excerpt from GMP Fundamentals

by Dr. Christine Oechslein

 
2016-04-15

The New Annex 16 – Eight Questions for Dr. Rainer Gnibl

The new revision of Annex 16 of the EU GMP Guide, “Certification by a Qualified Person and Batch Release,” was published in October, 2015, and went into effect on April 15, 2016. GMP Inspector Dr. Rainer Gnibl, Regierung von Oberbayern, Munic, joined us to discuss whether or not things are better or clearer now and what impact this document will have on the daily routine of the Qualified Person (QP).

 
 
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