GMP Focus – Downloads

A step-by-step guide to bring your drug manufacturing systems into compliance!

Correctly Implementing GMP and GDP Requirements

Current regulatory requirements and...

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

For auditors and manufacturers of drugs and APIs.

More than 650 typical questions...

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

A helpful guide which facilitates the entry into the GMP world and teaches the necessary...

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

A quarterly publication which provides in-depth analyses of international pharmaceutical...

How to Find and Fix Problems

A FDAnews publication

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

A number of different approaches can be taken when it comes to the qualification of analytical...

Step-by-step through the whole qualification process of water treatment systems including...

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

incl. an...

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

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

SOP "Technical Agreement and Delimitation of Pharmaceutical Responsibilities"
Standard...

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

A qualification serves to prove that equipment is fit for its given purpose. So far, so good....

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

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

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

SOP "GMP-Questionnaire: Contract Manufacturing / Contract Analysis"
Standard draft to adapt...

This sample document defines framework conditions and processes between contract givers and...