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GMP Subjects

Are you looking for help on a specific topic? Select your subject and get an overview of our publications in this area.

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Download NEW

A Pharma Guide to Planning and Constructing Cleanrooms

Planning and constructing cleanrooms is a complex task. Get to know how to successfully get...

€117.00 net

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Packaging Materials for Pharmaceutical Products

Handling packaging materials is a high-risk business because of the danger of mix-ups. Get to...

€117.00 net

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Core Processes in the Pharmaceutical Laboratory

GMP-Conform Sampling and Handling of Substances regulatory requirements methodological...

€117.00 net

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Evaluation of the environmental risks of medicinal products (free guideline)

Why are Environmental Risk Assessments necessary? What evaluation phases and methods do exist?...

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The Road to a Pharmaceutical Quality System

A step-by-step guide to bring your drug manufacturing systems into compliance!

€117.00 net

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Storage of Medicinal Products

Correctly Implementing GMP and GDP Requirements Current regulatory requirements and their...

€117.00 net

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GMP for Engineers

GMP knowledge for the planning, qualification and maintenance of the pharmaceutical equipment...

€269.00 net

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Specialist Knowledge GDP Compact

Regulatory requirements for transport and storage of pharmaceuticals Learning units...

€195.00 net

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PDE Report - Sample Document

Are you not quite sure what a PDE report looks like and would like to take a look inside? Get...

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OEL Categorisation - Sample Document

Are you not quite sure what an OEL categorisation looks like and would like to take a look...

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Elemental Impurities Risk Assessment - Sample Document

Are you not quite sure what an elemental impurities risk assessment looks like and would like to...

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How to implement ICH Q3D of elemental impurities in 5 steps (free manual)

Do you already know how to proceed after having obtained an Elemental impurities risk...

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Technical Agreement and Delimitation of Pharmaceutical Responsibilities

This SOP helps you to create and describe contracts correctly. Standard draft to adapt and extend

€87.00 net

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GMP Supplier Assessment Questionnaire

Ask your supplier the right questions - this questionnaire will help you! Standard draft to...

€87.00 net

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Top Ten Data Integrity Traps

How to Find and Fix Problems A FDAnews publication

€147.50 net

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GMP-Questionnaire: Contract Manufacturing / Contract Analysis

SOP "GMP-Questionnaire: Contract Manufacturing / Contract Analysis" Standard draft to adapt and...

€87.00 net

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Quality Agreement

This sample document defines framework conditions and processes between contract givers and...

€87.00 net

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Inspection of Process Validation

Do your validation processes meet their specified requirements? This bilingual guide offers an...

€59.00 net

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EU-Compliant Batch Release of Medicinal Products

How to Meet the GMP Requirements of Annex 16 EU GMP Guide Batch release is complex and...

€117.00 net

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Qualification and Validation: Agency Expectations

A qualification serves to prove that equipment is fit for its given purpose. So far, so good....

€117.00 net

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How to Manage Corrective and Preventive Actions (CAPA) in a GMP Environment

This e-book shows how you can establish an effective CAPA system, which interfaces there are to...

€87.00 net

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Successful Implementation of Electronic Document Management Systems

Various different aspects must be considered in order to transfer documentation management,...

€87.00 net

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How to design a Laboratory Data Management System

The introduction of a LDMS has an extremely positive impact on the efficiency and quality of the...

€87.00 net

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Aseptic Processing of Sterile Medicinal Products

A Guide to Aseptic Processing

€117.00 net

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