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TOP 5 GMP Downloads

1. Questionnaire for preparing GMP-inspections
More than 650 typical questions related to audits and inspections.


2. GDP Audit Checklist
More than 700 questions with reference to regulations.


3. GMP Fundamentals
A quick and comprehensive overview of the complex world of GMP.


4. Industry Guide to handle OOX Test Results
Every single step of the OOX process.


5. The New USP <1231>: Water for Pharmaceutical Purposes
A compact overview of the contents of the new version of USP <1231>.


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GMP Compliance Adviser

GMP in Practice: 24 chapters written by internationally renowned industry experts.

 

GMP Regulations: 8 chapters with the most important GMP guidelines and regulations.

 

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The New USP <1231>
Water for Pharmaceutical Purposes

a detailed Overview

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GMP LOGFILE Features

2018-06-19

PQ: The Link between Qualification and Validation

An excerpt from the GMP Compliance Adviser, Chapter 6.G  Performance Qualification

6 minutes reading time

by Thomas Peither, Ulrike Reuter, Rainer Röcker

 
2018-06-13

Data Integrity and the Problem of Getting It Done

A report on the ISPE European Annual Meeting 2018

8 minutes reading time

by Thomas Peither

 
2018-06-06

Test results outside defined criteria (OOX)

An excerpt of the GMP Series Download Industry Guide to handle OOX Test Results

by Dr. Markus Limberger

 
2018-05-23

Practical Issues on Supply Chain and Good Distribution Practice

A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2017

6 minutes reading time

by Susanne Sailer

 
2018-05-16

2017 – The GMP Regulations Report

by Sabine Rabus

 
2018-05-09

The Never-Ending Story of Annex 1 and the Obstacles of Aseptic Processing

A report on the ISPE European Annual Meeting 2018

8 minutes reading time

by Thomas Peither

 
2018-05-02

Layout of a Cleanroom Air Handling Unit

An excerpt from the GMP Compliance Adviser, Chapter 3.I Air Handling Technology

6 minutes reading time

by Harald Flechl

 
2018-04-25

Industry 4.0 - Inspiration for the Pharmaceutical Industry?

A report on the ISPE European Annual Meeting 2018

8 minutes reading time

by Thomas Peither

 
2018-04-18

Principles of Qualification

An excerpt from the GMP Series PDF Download Qualification and Validation: Agency Expectations

6 minutes reading time

by Michael Hiob, PhD

 
2018-04-11

Inspections & Audits: Pitfalls and Criteria for Success – Part 2

A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2017

6 minutes reading time

by Sabine Rabus and Christine Gräßlin


 
2018-04-04

Inspections & Audits: Pitfalls and Criteria for Success – Part 1

A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2017

4 minutes reading time

by Sabine Rabus and Christine Gräßlin

 

 
2018-03-28

Sampling Frequencies

An excerpt from the GMP Series PDF Download Microbiological Monitoring in Pharmaceutical Manufacturing

6 minutes reading time

by Hanfried Seyfarth, PhD

 
2018-03-21

What a Qualified Person must know about the recent cleaning validation updates – Part 2

6 minutes reading time

by Walid El Azab

 
2018-03-14

What a Qualified Person must know about the recent cleaning validation updates – Part 1

6 minutes reading time

by Walid El Azab

 
2018-03-07

General principles of hygienic design

An excerpt from the GMP Series PDF Download Applying the Principles of Hygienic Design to Solid Dosage Forms

8 minutes reading time

by Richard Denk

 
 
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