Shopping cart
Your shopping cart is empty

Show shopping cart...
Stay informed!

You’d like to be regularly informed on the latest developments in Good Manufacturing Practices?

 

Subscribe to our free GMP Newsletter LOGFILE!

>>> REGISTER NOW

Qualification / Validation

Qualification and Calibration of Laboratory Instruments in Pharmaproduction
A number of different approaches can be taken when it comes to the qualification of analytical instruments. But which one should you take?
This pdf download will help you mastering all phases of qualification and calibration!

incl. form for a requalification report, samples of a qualification plan and report, sample calibration SOP

NEW ++ NEW ++ NEW

 
 
Qualification of Pharma Water Supply Systems
Step-by-step through the whole qualification process of water treatment systems including sample documents for all stages! The qualification of pharma water systems has never been so easy!

NEW ++ NEW ++ NEW

 
 
Inspection of Process Validation
Do your validation processes meet their specified requirements?

This bilingual guide offers an excellent up-to-date approach on process validation. It facilitates the planning and execution of all necessary steps to be compliant.

NEW ++ NEW ++ NEW

 
 
A Pharma Guide to Cleaning Validation
Does your cleaning validation meet the current requirements of Annex 15 to the EU GMP Guidelines?
This report offers you practical strategies to implement an up-to-date cleaning validation and meet regulatory requirements.

 
 
Qualification and Validation: Agency Expectations
A qualification serves to prove that equipment is fit for its given purpose. So far, so good. But what are the actual fundamental requirements for a successful equipment qualification and what are the core elements of qualification work?

 
 
Data Integrity in the EU
Nowadays all regulatory authorities focus on data integrity and have their own data integrity guidelines - however, their regulations don’t always agree.
With this pdf download you will understand all the requirements! This report details the ins and outs of all three documents of EMA, MHRA and WHO and explains how the FDA regulations fit in.

 
 
Principles of Equipment Qualification
This pdf download lays out the basics of building a four-phase qualification plan - DQ, IQ, OQ and PQ - that satisfies US and EU requirements.

incl. checklists for carrying out a qualification plan and instructive diagrams

 
 
How to design a Laboratory Data Management System
The introduction of a LDMS has an extremely positive impact on the efficiency and quality of the work in and around the analytical laboratory.
This new management report offers practical strategies for designing and implementing a LDMS.

 
 
Computer System Validation in the EU
Discover the tools you need to develop your trans-national validation program.
Use this step-by-step guide to implement a computer validation program that will satisfy U.S. and EU regulations!

 
 
Managing Process Validation
A step-by-step guide based on real-world examination experience. Discover how to document process validation in a way that is sure to satisfy — and impress — regulators!

 
 
 
Page 1/1    1