The Journey from Compliance to Excellence

How can quality assurance and operational excellence be achieved successfully in everyday pharmaceutical work?

Those familiar with the fundamental works on operational excellence issued by Prof. Friedli are presented in this book with the findings of a benchmark study on quality management in the pharmaceutical industry as well as the results of a research project on quality metrics – all arrived at as part of the professor's further research at the University of St. Gallen (Switzerland).

The study findings form the basis for practical recommendations for the reader. Along with its holistic system approach, the book also offers a look at the future of quality management in the pharmaceutical industry. 

The most important requirement made of a medicinal product is efficacy, followed by safety and quality. But how do you go about detecting microbial and other impurities in products at reasonable cost? 

This book examines two major problematic issues in the area of analytical quality control and pharmaceutical microbiology, namely statistical sampling principles and use of near infrared spectroscopy in the analysis of starting materials. Examples and practical instructions are provided to facilitate use of microbiological risk assessment in labs, plus information is offered on practice-oriented sanitation programmes, culture media preparation, risk assessment and microbiological test procedure validation.   

As currently experienced in GMP inspections, the FDA in the U.S. A. and supervisory authorities in Europe are increasingly focussing on quality control in such areas as physico-chemical analysis and pharmaceutical microbiology. Accordingly the volume is rounded off with insights into current requirements and their practical implementation by noted authors from the pharmaceutical industry and pharma contract labs.

As a mix of field report and reference work, pharma technologie journal books enable efficient implementation of GMP requirements in daily practice. The individual volumes in the scientific series examine specific topics from the field of pharmaceutical technology. The topics are selected by a scientific advisory committee, with the books being issued by the advanced training institute Concept Heidelberg.

How do medicinal products come about? Which steps have to be taken between the initial idea and gaining regulatory approval for marketing the drug? 

Pharmaceutical companies that engage in research work closely monitor academic science for the development of new ideas on disease mechanisms and potential targets. If such a target seems promising, the search then begins in the research lab for a pharmacologically active molecule. This book explains the fascinating world of drug research and the long path from candidate molecule to completed drug, all in an accessible manner. 
Excerpt from the contents: Basic research | Preclinical and clinical development | Clinical trials | Statutory and regulatory Framework 

The search for the winning formula: Disease formation, treatment options and developmental successes | Economic aspects, financing and budgeting | Innovative concepts

An introduction for all those wishing to gain an overview of the phases that a drug goes through in its development, from inception to market readiness.

In the development of medical devices and medicinal products, audits are an important tool for assuring the quality of clinical trials, i.e. the well-being of trial subjects, the integrity and validity of trial data and the transparency of the processes followed. 

Now in its third, revised and expanded edition, GCP Auditing provides a comprehensive overview of GCP auditing methods and procedures, both in the clinical field and related areas such as production (GCP), pharmacovigilance (GVP), lab work (GCLP), non-interventional studies (NIS) and medicinal product trials. A description is provided of all audit steps from planning to completion, including every audit type used in clinical research and the above areas.

Aspects such as the auditing of computer systems and archiving are also addressed, along with the topics of risk management and inspections. People employed in the pharmaceutical/biotech industry, contract research organisations (CROs) and academic or commercial institutions will benefit from the authors' extensive quality assurance knowledge and experience in all areas of GCP auditing.

The book will help auditors to refine and broaden their audit knowledge, plus auditees will learn what auditors focus on in various audit types.

This new collection was compiled based on the previous list ”Blaue Liste”. It contains all cosmetic ingredients listed in an inventory based on the EC Cosmetic Directive including inactive ingredients with their INCI names (International Nomenclature Cosmetic Ingredients). There are some 8,000 substances and over 150,000 entries. Approximately 1,000 additional substances are listed in an annex for which meanwhile also an INCI name has been proposed by COLIPA (Comité de Liaison des Associations Européennes de l’Industrie de la Parfumerie, des Produits Cosmétiques et de Toilette).

The introductory texts with the table of contents, preface and directions for the use of the ”BLUE LIST” are trilingual (English/German/French), the total data (entries) are in English. Three indexes – also in English – for a quick search by particular criteria have been included.

Successful quality management in a GxP-regulated environment depends on the reliability (accuracy, consistency and completeness) of all collected data. Thus for such data to be deemed reliable, it has to be subjected to seamless controls throughout its lifecycle. Ensuring data integrity requires GxP departments and IT organisation to participate actively in complying with ALCOA+ principles, thereby necessitating implementation and regular checking of meaningful audit trails.

Information on whether and how data integrity can be ensured in everyday work is provided in this book, along with tips on what to take into account in implementation. 

From the contents:
Data governance systems · Cloud solutions · Standards for laboratory instrument software · Migration projects · Static data vs. dynamic data · Auditing · Audit trail · Analytical data life cycle

Also included: Answers by acknowledged experts to specific questions concerning data integrity and audit trail issues in pharmaceutical practice. 

As a mix of field report and reference work, pharma technologie journal books enable efficient implementation of GMP requirements in daily practice. The individual volumes in the scientific series examine specific topics from the field of pharmaceutical technology. The topics are selected by a scientific advisory committee, with the books being issued by the advanced training institute Concept Heidelberg.

Basic Knowledge and GMP Training for Employees in Pharmaceutical Companies

This practical book, the 7th edition of which is available meanwhile, is indispensable for the training of manufacturing companies staff in the pharmaceutical industry. The practice-based information was mainly compiled for new employees in the manufacture and university/college graduates.

Extensively dealt with is the subject of "quality assurance", which has become extremely important for the production. Increasing automation and the purposeful use of personal computers is also considered. The new edition is completely revised and richly illustrated. "Control questions" make it easy to learn the matter by yourself. Comprehensive index.

This newly-revised compilation reflects the substantial changes that have taken place in German genetic engineering legislation since 2007 – the year in which the German Federal Genetic Engineering Act and the EU Genetic Engineering Implementation Act underwent amendment pursuant to the Act for Departmental Research Reorganisation as governed by the German Federal Ministry of Nutrition, Environment and Consumer Protection. A little while later these particular laws were modified once again, this time due to amendments in the Federal Genetic Engineering Act, the EU Implementation Law and the Novel Food and Novel Food Ingredients Directive of 1 April 2008.

Not only that – at the end of the same month the Second Ordinance for Amendment of Regulations Governed by Genetic Engineering Law of 28 April 2008 led to extensive changes in the Genetic Engineering Documentation Ordinance, the Genetic Engineering Public Hearings Ordinance, the Genetic Engineering Procedural Ordinance and the Genetic Engineering Emergency Odinance. And as if that weren't enough, the Lisbon Treaty of 9 December 2010 resulted in replacement of the term EC by EU in many regulations as pursuant to the Federal Legislation Adaptation Act within the scope of the Federal Ministry of Food, Agriculture and Consumer Protection.

In line with European and national statutory requirements, Qualified Persons have to perform numerous extensive tasks and above all bear a high degree of responsibility for the quality of drugs and investigational medicinal products. Furthermore, EU regulations, laws and directives – particularly also of relevance for Qualified Persons – are constantly being revised and amended. 

As defined in the German Medicinal Products Act (AMG), Qualified Persons need to possess the necessary qualifications and keep abreast with all relevant developments and regulatory requirements in order to fulfil their role in accordance with applicable pharmaceutical law.

In this new edition published as part of the Pharma Technologie Journal series, authors from industrial circles, public authorities and the legal counselling field again provide expert knowledge and practical solutions for the everyday work of Qualified Persons.  

New features of the 2nd edition (2018) include:

• Liability and insurance matters of relevance to Qualified Persons
• Statutory provisions and new regulatory requirements
• OOS test results
• Investigational medicinal products
• Supply chain issues
• The challenge of supplier qualification on the Chinese market 
• German official translation of Annex 16 to the EU GMP Guideline (15.04.2016)    published in the Federal Gazette of 03.11.2017 

As a mix of field report and reference work, pharma technologie journal books enable efficient implementation of GMP requirements in daily practice. The individual volumes in the scientific series examine specific topics from the field of pharmaceutical technology. The topics are selected by a scientific advisory committee, with the books being issued by the advanced training institute Concept Heidelberg.

How do you produce tablets?

The life of the tablet maker is not a happy one - R.C. White already knew that in 1920.

This comprehensive illustrated reference work is indispensable for successful tablet production. In addition to the basics, various procedures with their advantages and disadvantages as well as numerous machines on the market are explained. 

Table of contents:

• Tablets: properties and standards
• Excipients: an overview with application examples
• Granulation: How is it done? What are the alternatives; what are the advantages and disadvantages?
• The process of compression: understanding the resulting tablet properties
• Tablet presses: Eccentric, rotary and special presses - similarities and differences
• Tips & Tricks: In case of complications, learn the causes and how to fix them.
• Tablet testing
• Printing, converting, filling, packaging and storing the finished tablets in the tablet factory.

Expert knowledge in the 4th, revised and expanded edition 2022: indispensable in development, production and quality management.

With this manual you will become a successful tablet maker!