Maas & Peither Ag Gmp Publishing
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The company was founded in 1999 by Anita Maas, Thomas Peither and Barbara Peither. Our idea was to publish a comprehensive GMP reference book to ease the implementation of GMP for our colleagues in the industry and the health authorities.
First the German Manual GMP-BERATER was published in 2000. In 2002 we added the CD-ROM and in 2004 the online version. Since then the GMP-BERATER reached the status of a standard in all German speaking countries.
The GMP-Manual in English, was launched in 2006 and is now distributed in over 50 countries in the world. The compendium is constantly updated by the participation of over 40 international authors.
Since March 2007 the online version of the GMP-MANUAL is available.
We understand ourselves as a neutral platform for GMP knowledge and are pleased to be your partner for all GMP questions and publications.
Other products in English language
As a series we publish the GMP Pocket Guide, small volumes of regulatory guidelines with an index in a handy format and various GMP books.
First the German Manual GMP-BERATER was published in 2000. In 2002 we added the CD-ROM and in 2004 the online version. Since then the GMP-BERATER reached the status of a standard in all German speaking countries.
The GMP-Manual in English, was launched in 2006 and is now distributed in over 50 countries in the world. The compendium is constantly updated by the participation of over 40 international authors.
Since March 2007 the online version of the GMP-MANUAL is available.
We understand ourselves as a neutral platform for GMP knowledge and are pleased to be your partner for all GMP questions and publications.
Other products in English language
As a series we publish the GMP Pocket Guide, small volumes of regulatory guidelines with an index in a handy format and various GMP books.
Autor
: Max Lazar, Staphan Rönniger, etc.
Género
: Technical Lierature
Número ISBN
: 3-934971-55-4
Distribuido en
EuropaDescription of book
Good Manufacturing Practice & ImplementationThis compendium for the pharmaceutical industry and their suppliers is the most extensive GMP knowledge database worldwide.
It contains descriptions of how to implement GMP, provides examples and templates and includes numerous checklists, figures and cross-references.
19 chapters and
30 regulations in
5 files plus CD-ROM
Your benefits:
- 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 SOPs
- 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
Satisfaction guaranteed: Test 14 days without charge
Content:
25 experts from the pharmaceutical industry, regulatory bodies and suppliers
present GMP implementation in files 1-3. Files 4 and 5 contain important GMP regulations from Europe, PIC/S, ICH, USA and WHO. Each regulation has a separate index.
On the CD-Rom you will find all contents of the GMP MANUAL with a professional search engine which will help you find the best reference straight away.
Files 1-3 GMP in Practice
- Quality Management
- Personnel
- Premises
- Facilities and Equipment
- Pharmaceutical Water
- Qualification
- Process Validation
- Cleaning Validation
- Computer Validation
- Risk Management
- Production
- Sterile Manufacturing
- Packaging
- Laboratory and Analytical Controls
- Documentation
- Research and Development
- Contract Manufacturing and Analysis
- Inspections
- Tools of Quality Assurance
Files 4-5 GMP Regulations
- Our EU-GMP-Guideline includes 19 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
Guidance for industry: Sterile Drug Products by Aseptic Processing- Current Good Manufacturing Practice
Guidance for industry: PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance
Guidance for industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application
21 CFR Part 820 - Quality System Regulation
- ICH Guidelines
Q1A Stability Testing of New Drug Substances and Products
Q1B Stability Testing: Photostability Testing of New Drug Substances and Products
Q1C Stability Testing: Requirements for New Dosage Forms
Q2A Text on Validation of Analytical Procedures: Definitions and Terminology
Q2B Validation of Analytical Procedures: Methodology
Q7A Good Manufacturing Practice for Active Pharmaceutical Ingredients
Q8 Pharmaceutical Development
Q9 Quality Risk Management
- PIC/S-Guidelines
PI 006 Recommendations on Validation Master Plan, IQ, OQ, Non Sterile Process Validation and Cleaning Validation
PI 007 Recommendations on the Validation of Aseptic Processes
PI 011 Good Practices for Computerized Systems in Regulated GXP Environments
PI 023-1 Inspections of Pharmaceutical Quality Control Laboratories
- WHO-Guidelines
Guide to Good Storage Practices for Pharmaceuticals