• gmp-verlag.de
  • GMP MANUAL Login
  • Shopping cart
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

Excerpts from the GMP Compliance Adviser

Questionnaire for preparing GMP-inspections
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!

 
 
GDP Audit Checklist
for the Storage and Transport of Pharmaceuticals

More than 700 questions with reference to regulations on preparing for and carrying out Good Distribution Practice (GDP) audits

 
 
Managing Contract Manufacturers and Testing Labs
A comprehensive step-by-step guide, which covers all aspects of selecting and managing contractors.

NEW ++ NEW ++ NEW

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

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

Excerpt from the GMP Compliance Adviser

 
 
Creating a Master Plan for Drug Warehousing, Transportation and Distribution
Guide to prepare 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.

 
 
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.

 
 
Computer System Validation in the EU
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.

 
 
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.

 
 
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.

 
 
Managing 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.

 
 
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.

 
 
ICH Q8, Q9, Q10
GMP Pocket Guide Volume 4
ICH Q8 – ICH Q9 – ICH Q10

The ICH guidelines Q8, Q9 and Q10 represent the current thinking on the development of quality systems across the lifecycle of a product.

 
 
 
Page 1/3    1   2   3