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GMP Subject Downloads

You are responsible for Good Manufacturing Practice (GMP). We provide the essential information you need:

  • GMP expert knowledge to base your decisions
  • Practical implementation support
  • Safety for your daily routine

These compilations of excerpts from the GMP MANUAL offer straightforward GMP information:

GDP Audit Checklist
for the Storage and Transport of Pharmaceuticals

More than 700 questions with references to regulations for preparing and carrying out GDP audits

GMP Audit Checklist
for Pharmaceutical and API Manufacturers

Checklist with more than 700 questions typically asked during GMP audits or inspections

Preparing for the EU GMP Inspection
This handbook tells you what you need to know about the similarities - and subtle differences - between FDA and EU GMP inspections.

Pharma Change Control
Strategies for Successful Company-Wide Implementation

Every page offers practical strategies to implement a company-wide change control program and meet FDA regulatory requirements.

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.

The Process of Freeze-Drying
A Model to Implement and Run a Compliant Freeze Drying Process

Creating a Master Plan for Drug Warehousing, Transportation and Distribution
Guide to preparing a company for compliance with Good Distribution Practice (GDP)

Manufacturing Sterile Products to Meet EU and FDA Guidelines
This management report spells out how U.S. and EU manufacturers must handle sterile processing.

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

A Process Approach to Pharmaceutical Quality Systems
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 Drug Manufacturer‘s Guide to Site Master Files
Instructions for preparing a Site Master File according to
PIC/S PE 008-4

Without an up-to-date Site Master File, you are not authorized to market pharmaceuticals to European customers.

GMP Compliant Documentation
How to create, organize, review and archive GMP related documents in pharmaceutical industries

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

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