The GMP Compliance Adviser is the most comprehensive GMP online knowledge portal worldwide, combining theory and practice in a successful way. It is used by more than 10000 professionals in over 50 countries.

Simplify your GMP business!

• Save time when you are looking for adequate regulations and interpretations
• Enjoy safety of the global leading GMP knowledge database
• Current GMP information & regulations at your fingertips
• Stay informed with our latest news:
  We check and observe 50+ websites of regulatory bodies, associations, etc. on a weekly basis

The GMP Compliance Adviser is an online publication that covers all aspects of Good Manufacturing Practice (GMP) in one source.

The GMP Compliance Adviser is presented in two parts:

a. GMP in Practice: GMP interpretations written by noted industry specialists and according to international GMP regulations.The “GMP in Practice” part is written by 88 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.

24 exclusive chapters – written by outstanding experts and inspectors. Pharmaceutical Quality System (PQS) – Personnel – Premises – Facilities and Equipment – Pharmaceutical Water – Qualification – Process Validation – Cleaning Validation – Computer System Validation – Quality Risk Management – Production – Sterile Production – Packaging – Laboratory Controls – Documentation – Research and Development – Contractors and Suppliers – Inspections – Quality Unit – Continual Improvement – Active Pharmaceutical Ingredients – Excipients – Medical Devices – Transport

b. GMP Regulations: The most important GMP regulations from Europe, USA, Japan and many more (e.g. PIC/S, ICH, WHO,...)

All relevant GMP regulations in one source – searchable with specific filters. Addresses – GMP Abbreviations – GMP Glossary – National Bodies and Pharmaceutical Associations – EU Directives and Guidelines – USA: CFR and FDA Guidelines – ICH-Guidelines – PIC/S Guidelines – Canadian Regulations – Japanese Regulations – Chinese Regulations – Indian Regulations – Australian Regulations – Brazilian Regulations – WHO Guidelines

Updates: All regulatory changes are covered, minor or big. With a high frequency update rate of 10x a year, which is equivalent to every 6 to 8 weeks, you are always up to date

Practical features and advantages of the GMP Compliance Adviser

· comfortable full-text search

· copy, paste & print

· bookmarks

· access via standard browser

· regular automatic updates

· e-mail notification about important revisions

The Online Single Licences allow access to the knowledge portal for one named user. Choose between:

• 3-month-subscription 390€ + ΦΠΑ
• 12-month-subscription – 1140 € +ΦΠΑ
• 24-month-subscription  - 2040 € +ΦΠΑ

  Η GMP Compliance Adviser χρησιμοποιείται από περισσότερους από 10000 επαγγελματίες σε περισσότερες από 50 χώρες.

•