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Good Manufacturing Practice & Implementation

GMP Compliance Adviser
Online Single Licences
The Online Single Licences allow access to the database for one named user. Choose between:
- monthly subscription
- yearly subscription

regularly updated

 
 
GMP Compliance Adviser
Online Corporate Licence
With the Corporate Licence all employees of your company will have access to the GMP Compliance Adviser Online. Everybody does work with one source. Available as:
- Subscriber licence (long-term) licence

regularly updated

 
 
GMP Fundamentals – A Step-by-Step Guide
This handbook is a practical and easy to read guideline, giving you a quick and comprehensive overview of the complex world of Good Manufacturing Practice (GMP).

NEW ++ NEW ++ NEW

 
 
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.

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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.

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Data Integrity in the EU
Requirements for Quality Management Systems

Excerpt from the GMP Compliance Adviser

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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.

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Top Ten Data Integrity Traps
How to Find and Fix Problems

A FDAnews publication

 
 
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.

 
 
 
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