GMP E-Book

Description | Topics | Fact Sheets | Purchase Information 

Description

The GMP E-Book provides instant downloads and support on hot topics in the GMP (Good Manufacturing Practices) areas.

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

Some of the topics include:

Topics

  • GMP Audit Checklist. Documenting Process Validation.Computer System Validation in the EU.
  • GDP Audit Checklist.
  • GMP Compliant Documentation.
  • Pharma Change Control.
  • Preparing for the EU GMP Inspection.
  • Managing Contract Manufacturers and Testing Labs.
  • The Drug Manufacturer‘s Guide to Site Master Files.
  • Premises.
  • A Process Approach to Pharmaceutical Quality Systems.
  • Medical Devices. Production.
  • Pharmaceutical Water.
  • Manufacturing Sterile Products to Meet EU and FDA Guidelines.
  • Aseptic Processing of Sterile Medicinal Products.
  • Microbiological Monitoring in Pharmaceutical Manufacturing.
  • The Process of Freeze-Drying.
  • Creating a Master Plan for Drug Warehousing, Transportation and Distribution.

Fact Sheets

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Purchase information

Further information available upon request.