Excerpts from the GMP Compliance Adviser

Step-by-step through the whole qualification process of water treatment systems including sample documents for all stages!

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More than 650 typical questions related to audits and inspections.

Each question with reference to the current EU GMP Guide Part I/II and the 21 CFRs 210/211/11.

For auditors and manufacturers of drugs and APIs.

NEW: Now modifiable!

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

NEW: now also for active substances and modifiable!

More than 700 questions with references to GMP/GDP regulations and EN ISO 13485 on the preparation and implementation of Good Distribution Practice (GDP) audits

Your perfect working tool: compact and practice-oriented!

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This report offers you practical strategies to implement an up-to-date cleaning validation and meet regulatory requirements.

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A "must have" guidance for all those who are involved in qualification and validation: It provides information about regulatory requirements, risk management, life cycle concepts and much more.

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Excerpt from the GMP Compliance Adviser

Requirements for Quality Management Systems - learn more about the principles of data integrity, systems to monitor data integrity and the storage and archiving of records.

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Excerpt from the GMP Compliance Adviser

A Guide for Drug and Device Manufacturers - learn more about the four phases of qualification.

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

A Guide to Aseptic Processing

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

Guide to prepare a company for compliance with Good Distribution Practice (GDP)

Just when you think you’ve got the FDA’s requirements figured out, the EU issues its own. Do you know how they differ? Here you'll find a step-by-step guide to implementing a computer validation program that will satisfy U.S. and EU regulations.

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.

A Guide to ICH Q10 Compliance

This ebook walks you step by step through the processes and procedures you’ll need to put in place. You’ll learn how to restructure your quality systems to satisfy GMP.

The deployment of human resources must be carefully planned and organised. In order to assist you in successful human resource management and training, we have compiled this detailed roadmap