• 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 Questionnaire
for the Transport and Storage of Medicinal Products for Human Use, Active Substances and Medical Devices

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

Pre-order now!

 
 
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.

NEW ++ NEW ++ NEW

 
 
Data Integrity in the EU
Excerpt from the GMP Compliance Adviser

Requirements for Quality Management Systems - learn more about the principles of data integrity, systems to monitor data integrity and the storage and archiving of records.

NEW ++ NEW ++ NEW

 
 
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.

NEW ++ NEW ++ NEW

 
 
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.

 
 
 
Page 1/3    1   2   3