What is the GMP
Compliance Adviser?
The most comprehensive GMP online knowledge portal worldwide, combining theory and practice:
up-to-date,
practical &
inspection-proven.
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Content
The pharmaceutical industry is subject to strict regulations. The primary goal is patient safety. However, GMP regulations are limited to formulating requirements (WHAT needs to be done?) without providing specific implementation proposals (HOW should it be done?).
The good thing about this is that pharmaceutical companies have room for manoeuvre.
The challenge, however, lies in making competent, risk-based decisions. This requires expertise, product and process knowledge, and methodological competence.
Thia is precisely where the GMP Compliance Adviser comes into play – the most comprehensive online knowledge portal all around Good Manufacturing Practice (GMP).
A team of over 80 experts interprets regulatory requirements and describes how they are implemented in practice. The authors draw on their many years of experience in the pharmaceutical industry, consulting and regulatory authorities.
GMP in Practice
The GMP Compliance Adviser covers a wide range of topics: in 21 chapters, you will find more than 5,000 pages of in-depth knowledge for your everyday GMP work.
Here you will find expert knowledge from practical experience and requirements from the authorities' perspective:
- Quality Management, Quality Risk Management & Quality Control
- Premises, Facilities & Media
- Qualification, Process Validation & Cleaning Validation
- Hygiene, Microbiology & Monitoring
- Production, Sterile Production & Packaging
- Storage & Transport
- Audits and Supplier Qualification & Inspections and Drug Safety
- Documentation
- Computerised Systems & Data Integrity
- Active Pharmaceutical Ingredients & Biotechnology
GMP Regulations
All relevant national, European and international GMP regulations are available in the GMP Compliance Adviser. Our editorial team keeps track of changes and updates for you, so that you always have access to the latest versions:
- EU GMP Guide & EU directives
- Regulations for Germany, Switzerland and Austria
- Regulations governing medical devices
- FDA regulations and guidelines
- Guidelines from ICH, PIC/S and WHO
Sample Documents
In addition, the GMP Compliance Adviser contains many sample documents and practical examples that you can use:
- Sample SOPs
- Sample protocols
- Sample forms
- Case studies
AI in the GMP Compliance Adviser
Your AI assistant GMP Chat supports you in your work in the GMP Compliance Adviser.
GMP Chat only accesses the verified knowledge of the GMP Compliance Adviser, so you receive well-founded, trustworthy answers, including sources.
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Your Options
Advantages of using the GMP Compliance Adviser
- Always have the latest relevant regulations at hand
- Receive helpful implementation recommendations from GMP practice experts
- Get access to useful working documents: templates, SOPs, checklists, flow charts, etc.
- Understand authorities’ expectations
- Increase GMP compliance Work GMP-compliantly and pass inspections more easily
- Receive continual updates throughout the year
- Comfortable full-text search
- Questions and answers via AI search
- GMP Chat Button for questions to the editors: Send your questions directly via email
- All content printable as PDF
- Bookmarks, favourites, notifications
- Information about new content via the "INSIDER" email
- Access via standard browser
Are you ready to start your journey to GMP Compliance?
Do you need all details in a PDF for your boss or buying department?
Map of PIC/S participating authorities (coloured dark blue).
Global Relevance of the GMP Compliance Adviser
Is your company located outside of the EU? You might be wondering whether the GMP Compliance Adviser and its contents are still relevant for you.
The answer is very likely yes. The PIC/S GMP Guide for Medicinal Products is almost identical to the EU GMP Guide. Both have been developed in close parallel since the early 1990s, ensuring a high level of alignment in their requirements and expectations.
Today, the PIC/S brings together 56 regulatory authorities from around the world.
Here you can find an overview of the members and their role in shaping global GMP practice.
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