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GMP Subject Downloads

Subject matter downloads provide instant support on hot topics in the GMP field
(Good Manufacturing Practices).

These compilations of excerpts from the GMP MANUAL offer straightforward GMP information:

GMP Audit Checklist
for Pharmaceutical and API Manufacturers

Documenting 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.

Computer System Validation in the EU
a step-by-step guide to implementing a computer validation program that will satisfy U.S. and EU regulations

GDP Audit Checklist
for the Storage and Transport of Pharmaceuticals

More than 700 questions with references to GMP Regulations for preparing and carrying out GDP audits

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

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

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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