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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 Questionnaire
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!

NEW ++ NEW ++ NEW

 
 
Failure Management in a GMP Regulated Environment
How can occured failures be avoided in the future? Start to treat the root cause, not the symptoms!

Learn how to set up a failure management system and how to use root cause analysis methods and tools correctly!

NEW ++ NEW ++ NEW

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

NEW ++ NEW ++ NEW

 
 
A Pharma Guide to Cleaning Validation
This report offers you practical strategies to implement an up-to-date cleaning validation and meet regulatory requirements.

NEW ++ NEW ++ NEW

 
 
Qualification and Validation: Agency Expectations
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.

 
 
Data Integrity in the EU
Requirements for Quality Management Systems

Excerpt from the GMP Compliance Adviser

 
 
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)

 
 
 
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.

 
 
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!

 
 
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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