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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 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
Requirements for Quality Management Systems

Excerpt from the GMP Compliance Adviser

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.

 
 
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.

 
 
 
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