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GMP Manual

Kontakt/Bestellung
Contact/Order
via E-Mail:
info@digento.de  

Good Manufacturing Practice & Implementation

Print + CD-ROM, CD-ROM, Online

Print: 2006 ff., ca. 3.000 Seiten, Loseblattwerk in 5 Ordnern

Inhalt :: Content

Umfassendes Handbuch mit detaillierten Beschreibungen zur Implementierung von GMP für die Pharmaindustrie und deren Zulieferer. Enthalten sind Beispiele und Vorlagen sowie zahlreiche Checklisten, Abbildungen und Verweise. Updates: halbjährlich.

Verlag :: Publisher

Maas & Peither GMP

Preis :: Price

Preise auf Anfrage / Prices on request

Das Angebot richtet sich nicht an Verbraucher i. S. d. § 13 BGB und Letztverbraucher i. S. d. PAngV.

ISBN/ISSN

978-3-934971-55-4 (Print + CD-ROM)

978-3-934971-23-3 (CD-ROM)

Bestellnummer bei digento :: digento order number

104367

Verlagsinformation :: Publisher's information

This compendium for the pharmaceutical industry and their suppliers is the most extensive GMP knowledge database worldwide.

It contains descriptions how to implement GMP, provides examples and templates and includes numerous checklists, figures and cross-references.

The complex GMP spectrum is explained clearly and in detail on 3,000 pages in 5 files accompanied by a CD-Rom showing the contents. As a special service there is a detailed index to find the right passage straigt away:

• 800 figures
  
• 3,000 pages
  
• 5,000 keywords
  
• 17 books and
  
• 25 regulations
  

contained within just 5 files

• important topics are written in a compact, concrete and clear manner
  
• numerous examples and ways of solving problems are shown
  
• more than 700 checklists, templates and examples of SOP´s
  
• important regulatory guidelines worldwide are included
  
• easy search in the index covering all chapters and regulations
  
• updated with new topics and current regulations twice a year
  

The GMP-MANUAL consists of 5 files plus CD-Rom

25 experts from the pharmaceutical industry, regulatory bodies and suppliers

have presented GMP implementation in files 1-3:

In files 4 and 5 you can find important GMP regulations from Europe, PIC/S, ICH, USA and WHO. Each regulation has a separate index.

On the CD-Rom you can find the total contents of the GMP MANUAL with a professional search engine to find the best reference straight away.

Files 1-3

• Quality management systems
  
• Personnel
  
• Quality control
  
• Documentation
  
• Contract Manufacturing
  
• Inspection
  
• Quality Assurance tools
  
• Clean rooms
  
• Equipment and facilities
  
• Pharmaceutical water systems
  
• Qualification
  
• Process validation
  
• Cleaning validation
  
• Computer system validation
  
• Production
  
• Sterile production
  
• Packaging
  
• Research & Development
  

Files 4-5

• EU-GMP-Guideline including 18 annexes
  
• FDA-Guidelines (USA)
  
• Code of Federal Regulations, Part 210, 211, 11
  
  
• Guideline on general principles of process validation
  
• Guide to inspection of high purity water systems
  
• Guide to inspection of validation of cleaning processes
  
• Guide to inspection of oral solid dosage forms
  
• Guide to inspection of validation documentation (lost guide)
  
• Guide to inspection of computerized systems in drug processing
  
• Guide to inspection of pharmaceutical quality control laboratories
  
• Guidance for industry: Investigating Out of Specification (OOS) Test Results for pharmaceutical Production
  
• ICH Guidelines
  
• Q1A
  
• Q1B
  
• Q1C
  
• Q2A
  
• Q2B
  
• Q7
  
• Q9
  
• PIC/S-Guidelines
  
• PI 006 Recommendations on Validations Master Plan,...
  
• PI 011 Good Practices for computerised Systems in Regulated "GXP" Environments
  
• WHO-Guidelines (Guide to good storage practices for pharmaceuticals)
  

Our experts

Dr. Gero Beckmann - Labor L+S AG • Wilfried Bellack - former Schering AG • Dr. Helmut Bender - Boehringer lngelheim Pharma KG • Dr. Doris Borchert - Pfizer AG • Richard Denk - Hecht Anlagenbau • Dr. Ulf Fuchslueger - Vialis • Dr. Christian Gausepohl - Rottendorf Pharma GmbH • Dipl.-Ing. Michael Gronwald - Hoffmann La Roche AG • Dr. Michael Hiob - Ministry of Health of the federal state Schleswig-Holstein (GER) • Thomas Kamm - Lang Apparatebau GmbH • Ursula Klös - Schering AG • Dr. Josef Künzle - Permamed AG • Dr. Christine Oechslein - Novartis Pharma AG • Dipl.-Ing. Barbara Peither - Peither Consulting • Dipl.-Ing. Thomas Peither - Peither ConsuIting • Andreas Rösch - ProLeit • Dipl.-Ing. Matthias Schaumann - Schering AG • Michael Schulte - Qualitätssicherung-Systeme und Beratung • Dipl.-Ing. Uwe Schwarzat - Boehringer lngelheim Pharma KG • Dr. Hanfried Seyfarth - former Boehringer Ingelheim Pharma

Board of trustees:

A high professional team of experts from industry, regulators, universities and consultants conduct the advancement of the GMP MANUAL:

• Dr. Helmut Bender - Boehringer Ingelheim Pharma KG
  
• Dr. Michael Hiob - Ministry of Health of the federal state Schleswig-Holstein (GER)
  
• Member of EMEA working groups
  
• Dr. Hiltrud Horn - HORN Pharmaceutical Consulting
  
• Dr. Josef Künzle - Permamed AG, Member of APIC/CEFIC
  
• Dr. Thomas Schneppe - Schering AG
  
• Prof. Ronald Ziegler - University of applied science Albstadt-Sigmaringen, Member of GAMP Forum
  

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