GMP Focus – Downloads

More than 650 typical questions related to audits and inspections.
Each question with...

for the Transport and Storage of Medicinal Products for Human Use, Active Substances and...

This handbook is a practical and easy to read guideline, giving you a quick and comprehensive...

The draft of Annex 1 of the EU GMP Guidelines keeps numerous responsible persons in the...

This download shows you procedures you can implement now that ensure the successful management...

What has changed compared to the last version? Are there new requirements that did not...

A Guide to Control Microbial Risks in Sterile and Aseptic Drug Manufacturing

This download covers all aspects you have to consider when transferring!

incl. an...

This pdf download shows how you can establish an effective CAPA system, which interfaces there...

GMP Supplier Assessment Questionnaire for Active Pharmaceutical Ingredients (API) and...

A comprehensive step-by-step guide, which covers all aspects of selecting and managing...

This pdf download leads you step by step through the 4 key processes in microbiological...

This pdf download lays out the basics of building a four-phase qualification plan - DQ, IQ, OQ...

Nowadays all regulatory authorities focus on data integrity and have their own data integrity...

A step-by-step guide based on real-world examination experience. Discover how...

This pdf download is the ultimate guide to preparing your company for compliance with GDP....

How to Find and Fix Problems

A FDAnews publication

What is the GMP-compliant approach and what do the single steps in the process flow look like?...

The introduction of a LDMS has an extremely positive impact on the efficiency and quality of...

Introducing and implementing an EBR system requires systematic analysis, definition and...

In this pdf download you'll find answers on how deviations are defined, what must be observed...

The deployment of human resources must be carefully planned and organised. In order to assist...

Various different aspects must be considered in order to transfer documentation management,...