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Customers Opinion

Recommended by PDA (Parenteral Drug Association):

 

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Bob Dana, Sen. VP Regulatory Affairs

 

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GMP Quality Assurance

Quality Agreement
Quality Agreement
Standard draft to adapt and extend

NEW ++ NEW ++ NEW

 
 
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 Expipients
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, arranged by subject-matter

 
 
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.

 
 
 
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