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Recommended by PDA (Parenteral Drug Association):

 

"... The GMP MANUAL occupies a spot in my bookcase and I often have the occasion to refer to it. If you are a professional in the field of GMP and regulatory compliance, you may find it should be in your bookcase too."

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GMP Quality Assurance

Quality Agreement
Quality Agreement
Standard draft to adapt and extend

 
 
Technical Agreement and Delimination of Pharmaceutical Responsibilities
Technical Agreement and Delimination of Pharmaceutical Responsibilities
Standard draft to adapt and extend

NEW ++ NEW ++ NEW

 
 
GMP-Questionnaire: Contract manufacturing / Contract analysis
GMP-Questionnaire: Contract manufacturing / Contract analysis
Standard draft to adapt and extend

NEW ++ NEW ++ NEW

 
 
GMP Supplier Assessment Questionnaire
GMP Supplier Assessment Questionnaire for Active Pharmaceutical Ingredients (API) and Excipients
Standard draft to adapt and extend

NEW ++ NEW ++ NEW

 
 
GMP Audit Checklist
for Pharmaceutical and API Manufacturers

Checklist with more than 700 questions typically asked during GMP audits or inspections

 
 
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

 
 
GMP Compliant Documentation
How to create, organize, review and archive GMP related documents in pharmaceutical industries

 
 
A Process Approach to Pharmaceutical Quality Systems
A Guide to ICH Q10 Compliance

This ebook walks you step by step through the processes and procedures you’ll need to put in place. You’ll learn how to restructure your quality systems to satisfy GMP.

 
 
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.

 
 
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.

 
 
Risk Management
established methods of risk analysis
incl. ICH Q9

 
 
Laboratory & Analytical Controls
This title deals with the main subjects in Laboratory and Analytical Controls.

 
 
ICH Q8, Q9, Q10
GMP Pocket Guide Volume 4
ICH Q8 – ICH Q9 – ICH Q10

The ICH guidelines Q8, Q9 and Q10 represent the current thinking on the development of quality systems across the lifecycle of a product.

 
 
Medical Devices
GMP requirements for medical devices

 
 
Quality by Design
Putting Theory Into Practice

 
 
 
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