GMP Compliance Adviser – Named User Licence
An online publication that covers all aspects of Good Manufacturing Practice (GMP) in one source.
- 1 named user
- 3-month-subscription
- ends automatically
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The GMP Compliance Adviser is an online publication that covers all aspects of Good Manufacturing Practice (GMP) in one source.
In the GMP Compliance Adviser you’ll find:
GMP in Practice
This part contains 21 chapters with GMP expert knowledge to base your decisions upon. It provides practical assistance with checklists, templates and SOP examples.
It is written by 81 authors with hands-on experience directly linked to the industry. The individual chapters describe the different aspects of GMP in a clear language. Technical, organizational and procedural aspects are covered. More than 700 checklists, templates and examples of standard operation procedures taken directly out of the practice help you in understanding the GMP requirements.
GMP Regulations
These 8 chapters cover the most important GMP regulations from Europe and the United States (CFR and FDA), but also PIC/S, ICH, WHO and many more.
Chapter overview
Please click or tap the arrow.GMP in Practice
Current topics
0.A Nitrosamines
0.B Cannabis
0.C ATMPs
0.D Remote Audits and Inspections
0.E The 2021 PDA/FDA Joint Regulatory Conference: A First-hand Insight
0.F Importation of Medicinal Products
1 Quality Management Systems
2 Personnel
3 Premises
4 Facilities and Equipment
5 Pharmaceutical Water
6 Qualification
7 Process Validation
8 Cleaning Validation
9 Computerised Systems
10 Hygiene
11 Production
12 Sterile Production
13 Packaging
14 Laboratory Controls
15 Documentation
16 Storage and Transportation
17 Outsourced Activities
18 Audits and Supplier Qualification
19 Quality Risk Management
20 Active Pharmaceutical Ingredients
21 Inspections and Drug Safety
GMP Regulations
A Addresses
B National Bodies and Pharmaceutical Associations
C EU Directives and Guidelines
D USA: CFR and FDA Guidelines
E ICH Guidelines
F PIC/S Guidelines
G GMP of other Regions
- Canadian Regulations
- Japanese Regulations
- Chinese Regulations
- Indian Regulations
- Australian Regulations
- Brazilian Regulations
H WHO Guidelines
Information
- Update history
- GMP Abbreviations
- GMP Glossary
- Contributors
Reach your GMP compliance with the support of the provided knowledge!
Practical features and advantages of the GMP Compliance Adviser
- comfortable full-text search
- copy, paste & print
- bookmarks
- access via standard browser
- regular automatic updates
- email notification about important revisions
Free trial!
The GMP Compliance Adviser is used by more than 10000 professionals in over 50 countries.
Discover for yourself and take a look into this unique, powerful and dependable GMP reference tool:
>>> Get your free demo access now – it ends automatically!
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Any questions? Just get in touch with me! Annette Crawford, crawford@gmp-publishing.com, +49 (0)7622 66686-74 |
Weitere Links "GMP Compliance Adviser – Named User Licence"
GMP Compliance through better GMP knowledge – Interview with Thomas PeitherAdvantages and Prices
Von Katrin Am 22.01.2025Very helpful resource
The GMP Compliance Adviser is very helpful. You get all the current regulatory information as well as detailed information about any topics related to pharmaceutical engineering. All information are clear and understandable. It's a very good source for retrieving information and training.
Am 30.11.2023Very useful information
A lot of useful and practical information. Structured and complete!
It is very useful for day-to-day activity and during checks.
Am 27.02.2023The most comprehensive GMP resource I have ever used
I used to spend hours browsing for answers and sometimes finding contradictory information.
The compliance adviser does it all: it provides updated regulations AND most importantly, insightful and comprehensive interpretation.
It has become my first stop when researching a subject, be it for consulting or for training. And there is always new content added which is awesome.
Am 27.01.2020Excellent tool
This tool is really great and provides you with access to all the guidelines you will need as a Pharmaceutical Quality Expert and in many other functions in the Industry.
Am 20.12.2019An indispensable tool for everyone in the GMP area
The GMP Compliance Advisor is an indispensable tool for everyone who works in the regulated pharmaceutical sector. It allows tough decisions to be made. Access via the Internet is very convenient, and one always has the most up-to-date information at hand. Important areas of interest can be saved in the form of favorites, and individual subject areas can be saved and printed out. The GMP guide is a comprehensive collection of regulations and guidelines that are not just available in the original, but are also very well prepared, commented on. I highly recommend using GMP Compliance Advisor.
Am 21.10.2019GMP Adviser is inescapable
GMP Adviser helps my consulting with international customers. I can not be without it, because I can trust its actuality, correctness and competence. QP is a job with always approving compliance. And in case of doing this job also internationally the use of the GMP Adviser is inescapable. I'm glad to be able to use the Adviser and will not miss it.
Am 07.10.2019Bibel for Quality management
GMP advisor is one of the best collective of all the information needed for establish and maintain a good quality management system. It offers not only a entrance to the regulatory and technical knowledge database for beginner but also a helpful tool for experienced quality personnel.
Am 29.05.2019The GMP Manual is an important source in the daily working process. It is quite explicit, clear and useful, with a straightforward interface. All chapters of the GMP guide are sometimes thoroughly explained by understandable examples efficient in practice
The GMP Manual is an important source in the daily working process.
It is quite explicit, clear and useful, with a straightforward interface.
All chapters of the GMP guide are sometimes thoroughly explained by understandable examples efficient in practice.
From a professional point of view, it is a very good source of training.
The GMP Compliance Adviser is very easy to use!
You just need internet access with one of these browsers:
- Explorer (at least: 7)
- Firefox (at least: 3.6)
- Chrome (at least: 17)
In order to improve our services and make them more interesting for you as a user, we analyse the use of our knowledge portal GMP Compliance Adviser. Further information can be found in our data privacy statement.
Safety for your daily routine
You are always up to date.
Each update includes either entire new chapters, or some chapters may be partially renewed/supplemented according to the latest GMP guidelines. All regulatory changes are covered, minor or big.
You won’t miss any important changes, because you will be automatically informed about the updates with our e-mail service Insider.
Click here to learn more about content of updates.
Licence agreement
Note for the user: This is a contract between you (“licensee”) and the GMP-Verlag Peither AG (“licenser”). By using the knowledge portal on your computer you agree on all terms and conditions of the present contract. All rights to the knowledge portal are with the GMP-Verlag Peither AG.
This licence agreement applies for the following product:
GMP Compliance Adviser
When acquiring a named user licence the following agreement applies:
You obtain the simple, non-exclusive, personal and non-transferable right to use the knowledge portal after receiving the payment and setup of the access. The right of utilisation only applies to you and cannot be transferred to third parties.
You purchase a license with a minimum term of 3 or 12 months.
The three-month license expires automatically after the minimum term without any cancellation required. The twelve-month license may be terminated in writing to the expiry of the respective minimum term with a notice period of 1 month to the month-end. Otherwise the license will be extended automatically for another 12 months. The GMP-Verlag Peither AG is particularly entitled to terminate the contract for cause without proper notice if the licensee does not pay in time or provably misuses the knowledge portal.
When acquiring a corporate licence the following agreement applies:
This is a concurrent licence model: it allows multiple users the access, but limits the number of simultaneous users to the number of licenses purchased. After receiving the payment and setup of access you will obtain the right of utilisation.
You purchase a license with a minimum term of 12 months.
The twelve-month licenses may be terminated in writing to the expiry of the respective minimum term with a notice period of 1 month to the month-end. Otherwise the license will be extended automatically for another 12 months. The GMP-Verlag Peither AG is particularly entitled to terminate the contract for cause without proper notice if the licensee does not pay in time or provably misuses the knowledge portal.
If you have any questions about this present contract or would like to have any information, please contact
GMP-Verlag Peither AG
Karlstrasse 2
79650 Schopfheim (near Basel)
Fax +49 7622 66686-77
E-mail: service@gmp-publishing.com
Web: www.gmp-publishing.com
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