Inhaltsverzeichnis

Vorwort

Foreword

From a historical point of view, the European Medicines Agency (i.e. EMEA) required already in the "Note for Guidance on Development Pharmaceutics" (1998) the identification of critical process steps. On an international level risk assessment for the identification of the scope and extent of validation was first mentioned in the Annex 15 (Guide to qualification and validation).

In 2002 the subject was intensified by the beginning of the following initiative by the FDA "cGMP for the 21^st century - a risk based approach". In 2003 the "Scope and Application-Guideline" related especially to 21 CFR Part 11 followed, which also required a risk assessment. This is reflected in an independent article on IT risk management.

Concerning the pharmaceutical industry the subject reached a temporary culmination point in November 2005 with the publication of the ICH document Q9 "Quality Risk Management" as step 4. The objective of this document is the applicability of risk management to different aspects in the pharmaceutical industry. Risk management is regarded as life cycle approach. ICH Q9 is considered to be applicable to inspections and audits too. The article by a GMP inspector describes an example of risk based inspections by the authorities. In what way the risk based approach can be applied to audits is explained by a representative of the industry.

But what sort of risk management tools are required by the publications of rules in the pharmaceutical environment? To be precise - none at all. An outline illustrates which tools can be applied at all.

But what does the life cycle approach mentioned in ICH Q9 mean? It means the lifecycle of a drug product accompanied by a risk management system. It starts with the development of the drug product and ends with the final control of it. To be precise, it doesn't end there. Already the purchase of the starting material is an extremely important step in the "supply chain". Hence, in the best case it should already be integrated in an in-house risk management system. Read from a trader's point of view how risk management concerning the starting material can be practised. The emphasis of the article lies on the storage and the transport of starting materials. Today this is known under the key words "good storage practice" and "good transportation practice." A product for parenteral application is used as an example to show in what way risk management can be practised with the risk assessment tables, a special risk management tool. A further example for a risk management tool is the HACCP analysis. In this journal an article about the applicability of this tool in the production of solid drugs can be read. Basis for the control of the product are qualified analytic instruments. In an independent article one can read about risk analysis in this connection. For all the examples mentioned above a technical infrastructure is needed. But how does risk management in engineering take place? The following report also contains an article concerning this question.

Last but not least one can learn about the pros and contras of a risk management based on EDP tools. The future will show how these systems will spread in the pharmaceutical environment.

With this GMP report the reader has a reference book at hand that illuminates selected aspects of risk management concerning pharmaceutical enterprises.

The papers in this issue of the GMP REPORT were selected and judged in the tried-and-tested manner by a scientific committee comprised of the following gentlemen:

Dipl.-lng. Eberhard Münch

Carpus Prozess Experten GmbH, Hattersheim (Germany)

Dr. Heinrich Prinz

PDM-Consulting, Groß-Zimmern (Germany)

Dr. Wolfgang Schumacher

F. Hoffmann-La Roche AG, Basel (Switzerland)

Klappentext

Risk Management in the Pharmaceutical Industry

• Regulatory Requirements
• Overview on Risk Management Tools
• Case Studies
• Computer-assisted Risk Management