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See for yourself how GMP Compliance Adviser provides you with state-of-the art GMP know-how that will simplify your daily business!

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GMP-Newsletter: LOGFILE

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GMP Compliance Adviser Excerpts

Alle Auszüge aus dem GMP Compliance Adviser auf einen Blick:

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 references to regulations for preparing and carrying out GDP audits

Principles of Equipment Qualification
Excerpt from the GMP Compliance Adviser

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


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

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.

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.

The Drug Manufacturer‘s Guide to Site Master Files
Instructions for preparing a Site Master File according to PIC/S PE 008-4

Pharma Change Control
Strategies for Successful Company-Wide Implementation

Computer System Validation in the EU
Discover the tools you need to develop your trans-national validation program.
This ebook is a step-by-step guide to implementing a computer validation program that will satisfy U.S. and EU regulations!

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.

The Process of Freeze-Drying
How is freeze-drying performed and what are the relevant process parameters to be measured?

Microbiological Monitoring in Pharmaceutical Manufacturing
Which microbial contamination risks must be anticipated during the manufacture of sterile preparations?

Aseptic Processing of Sterile Medicinal Products
A Guide for Aseptic Drug Manufacturing Requirements

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