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Quality Unit

You are responsible for Good Manufacturing Practice (GMP).
We provide the essential information you need: GMP expert knowledge to base your decisions.

Managing Outsourced GMP Activities Successfully
This download shows you procedures you can implement now that ensure the successful management of your outsourced GMP activities.

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.


GDP Audit Checklist
for the Storage and Transport of Pharmaceuticals

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

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.

Quality Agreement
This sample document defines framework conditions and processes between contract givers and contract acceptors in order to meet the mandatory quality criteria.

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.

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.

GMP Supplier Assessment Questionnaire
GMP Supplier Assessment Questionnaire for Active Pharmaceutical Ingredients (API) and Excipients
Standard draft to adapt and extend

GMP-Questionnaire: Contract manufacturing / Contract analysis
GMP-Questionnaire: Contract manufacturing / Contract analysis
Standard draft to adapt and extend

Technical Agreement and Delimitation of Pharmaceutical Responsibilities
Technical Agreement and Delimitation of Pharmaceutical Responsibilities
Standard draft to adapt and extend

Microbiology in Pharmaceutical Manufacturing
Volume I and II

The goal of this book is to provide updated and expanded microbiological information for the benefit of a global audience of stakeholders.

Implementing a World Class Deviation Management
In this pdf download you'll find answers on how deviations are defined, what must be observed in handling deviations, who is responsible for managing deviations and what interfaces to other systems there are.

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.

Roadmap to Manage Personnel in Pharmaceutical Manufacturing
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

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