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Qualification / Validation

Documenting Process Validation
A Drugmaker‘s Guide

Here’s a step-by-step manual based on real-world examination experience. You’ll discover how to document process validation in a way that’s sure to satisfy — and impress — regulators.

Computer System Validation in the EU
a step-by-step guide to implementing a computer validation program that will satisfy U.S. and EU regulations

Computer Validation
GMP Pocket Guide Volume 2
- 21 CFR Part 11 Electronic Records, Electronic Signature
- PIC/S PI 011 Good Practices for Computerised Systems in Regulated ”GxP“ Environments
- EU-GMP-Guideline Annex 11 Computerised Systems

Computer Infrastructure Qualification For FDA Regulated Industries
This book provides practical information to enable compliance with computer infrastructure requirements including the verification activities related with the design and deployment.

Validation of Analytical Methods for Biopharmaceuticals
A Guide to Risk-Based Validation and Implementation Strategies

The book contains many practical tips, tools and case studies that will allow validation scientists and management to make good risk-based decisions.

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