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Why GMP-Verlag?

Are you responsible for GMP, the Good Manufacturing Practice? We provide you with what you need – up-to-date, practical and inspection-proven.

1. Up-to-date

Here you will find all relevant and current GMP requirements in one place.

Save yourself time-consuming online research and the question of whether the results are up-to-date or not.

 

2. Practice-oriented

More than just laws and regulations: you can draw on the knowledge and experience of our large team of GMP experts.

For you, we combine experience from industry and consulting practice with expectations from the perspective of the authorities to provide you with practical implementation aids.

 

3. Reliable

“Where does it say that?” – You will find references to regulatory requirements in all our knowledge portals for precisely this question.

We offer you security in your everyday GMP work so that you can look forward to the next inspection with confidence.

 

4. Comprehensible

Let us guide you through the “regulatory jungle” and show you how to implement the requirements.

Complex topics are explained clearly and vividly using examples, graphics, checklists and videos.

 

5. Supportive

You are our focus. Good customer service is particularly important to us.

And if you have any questions, please contact us – we are happy to help!

The Range of GMP Products

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GMP Compliance Adviser

GMP Compliance Adviser

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 more than 80 authors with hands-on experience directly linked to the industry. The individual chapters describe the different aspects of GMP in clear language. Technical, organizational and procedural aspects are covered.More than 700 checklists, templates and examples of standard operation procedures taken directly out of practice help you in understanding the GMP requirements.GMP RegulationsThese 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.  Sample Documents In addition, the GMP Compliance Adviser contains many sample documents and practical examples that you can use.

delivery time appr. 2-5 workdays after receipt of payment
€597.00 net excl. VAT
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GMP:KnowHow Pharma Logistics (GDP)

GMP:KnowHow Pharma Logistics (GDP)

Your knowledge base about GDP-compliant handling of your pharmaceutical logistics. It is important that you as a logistics service provider, but also as a client in the pharmaceutical industry, adhere precisely to the regulatory requirements. The GMP:KnowHow knowledge portal guides you through the regulatory jungle of the pharmaceutical and logistical supply chain! The knowledge portal gives you an easy-to-understand overview of all the important topics. Using graphics, you can easily navigate through all the areas covered by the EU GDP Guidelines (2013/C 343/01). You also have the relevant passages of the regulations directly at hand for each topic. This allows you to compare the requirements directly and saves you a lot of time on time-consuming searches and research!One thing is certain: the knowledge portal answers your questions about the supply chain of medicinal products, active pharmaceutical ingredients and medical devices. You don't have to be an expert. Yet.You will find answers to your questions in the GMP:KnowHow Pharma Logistics (GDP). Where does GDP begin, where does GMP end? What does GDP-compliant mean? When do I also have to take GMP requirements into account? What permits do I need for certain activities? What requirements do I have to fulfil? What is the current legal basis? How am I covered? What authorizations do I have for my work, e.g. from my employer? Who is responsible — the client or the contractor? And many more What is the difference to the GMP Compliance Adviser? The GMP:KnowHow Pharma Logistics (GDP) is your guideline for Good Distribution Practice. It is a product that is independent of the GMP Compliance Adviser and concentrates on content that is essential for carriers of medicinal products, active pharmaceutical ingredients and medical devices as well as for logistics clients. The focus is on practical knowledge and how to apply it in your daily business. If necessary, the relevant regulations can be called up immediately alongside the practical knowledge, and you can see the relevant paragraphs at a glance. In addition, sample documents are available to help you make immediate progress. AuthorSimone Ferrante – now Director Quality at Fisher Clinical Services – was previously Head of Quality Control and Responsible Person according to GDP (VP) for the entire Grieshaber Group. She is also a long-standing author and GDP expert at GMP-Verlag.

delivery time appr. 2-5 workdays after receipt of payment
€460.00 net excl. VAT
Details
E-Learning GMP:READY | Specialist Knowledge GDP Compact

E-Learning GMP:READY | Specialist Knowledge GDP Compact

Are you looking for a way to train yourself or your colleagues efficiently? With this e-learning course you will get familiar with the topic of Good Distribution Practice (GDP) within a few hours! The key objective is familiarizing with the principles of the GDP regulations. With many day-to-day examples you will get an easy access to expert knowledge: Your personal experience will be interactively linked to GDP specific aspects. This knowledge transfer makes it easy for trainees to remember subject matters. Demanding exercises improve the learning process of the concentrated knowledge. The content gives concrete instructions for your work. Important aspects are the GDP regulations, qualification and validation, documentation, recording, responsibilities and behaviour at deviations. In Part A "Basic GDP Requirements" you will get in touch with the basic requirements of transport and storage of pharmaceuticals.In Part B “New Focus of the GDP Guidelines” you will get to know the focal points of the new EU-GDP guidelines.After the completion of both parts, you will be familiar with all essential GDP regulations.Your advantages: Fast familiarization with the topic of GDP within approx. 2 hours (corresponds to one day of external training), time- and place-independent training, printable personal certificate, training content can be used for 12 months, automatic updates in the case of legal changes,content and terminology comply with the obligation to provide evidence in accordance with Article 7(4) of Directive 2003/94/EC.

delivery time appr. 2-5 workdays after receipt of payment
€175.00 net excl. VAT
Details
E-Learning GMP:READY | Specialist Knowledge GMP for Engineers

E-Learning GMP:READY | Specialist Knowledge GMP for Engineers

Why are GMP rules important for technicians and engineers? Technicians and engineers play a key role in ensuring compliance with Good Manufacturing Practice (GMP) standards. They are involved in critical activities such as: planning and construction of ventilation systems, maintenance of water treatment plants, calibration of measuring sensors. Therefore, they are jointly responsible for the quality of medicines and must ensure that their work complies with GMP standards.Your advantages: Fast familiarization with GMP topics in approx. 2 hours, time- and location-independent online training, printable personal certificate, 12-month access for initial and follow-up training, automatic updates in case of legal changes,content compliant with Article 7(4) of Directive 2003/94/EC.The Author This e-learning course was developed with the collaboration of Dipl.-Ing. Andreas Nuhn (D & B Pharmadesign GmbH).

delivery time appr. 2-5 workdays after receipt of payment
€245.00 net excl. VAT
Details
GMP Fundamentals | A Step-by-Step Guide

GMP Fundamentals | A Step-by-Step Guide

This handbook is a practical and easy to read guideline, giving you a quick and comprehensive overview of the complex world of Good Manufacturing Practice (GMP) without the need of previously acquired knowledge. Some topics are: GMP: Purpose and basic pharmaceutical terms Laws, licenses and inspections Personnel: Responsibility and hygiene Standard Operating Procedures (SOP) and documentation Design of rooms and facilities Processing and packaging Quality control and market release Suppliers, storage and logistics (Good Distribution Practice = GDP) Alphabetical index and abbreviations Using practical examples and comparisons to every-day life will help to easy understand GMP regulations.GMP Fundamentals is a helpful guide which facilitates the entry into the GMP world and teaches the necessary basics.

delivery immediately after receipt of payment
€44.90 net excl. VAT
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Current GMP Topics

PIC/S: Revised Recommendations on Qualification and Validation
News

PIC/S: Revised Recommendations on Qualification and Validation

PIC/S has published a fundamentally revised version of its “Recommendations on Qualification and Validation” (PI 006-4). The new document was issued on 30 July 2026, will enter into force on 1 October 2026, and replaces the 2007 edition. The revised document has been expanded from 26 to 49 pages.
Read more
How do Components like Filling Needles and Laminarisators Affect First Air Integrity?
Question of the Week

How do Components like Filling Needles and Laminarisators Affect First Air Integrity?

Here's the answer:
Read more
Smart Strategies for Handling Indirect Product Contact Components
LOGFILE Feature

Smart Strategies for Handling Indirect Product Contact Components

Aseptic filling processes: Handling indirect product contact parts in compliance with the revised Annex 1 of the EU GMP Guide.
Read more
Swissmedic: Implementation of New EU GMP Implementing Regulations for Veterinary Medicinal Products
News

Swissmedic: Implementation of New EU GMP Implementing Regulations for Veterinary Medicinal Products

The new EU Implementing Regulations on GMP requirements for veterinary medicinal products and active substances will not be automatically transposed into the Swiss Medicinal Products Licensing Ordinance (MPLO) on 16 July 2026. Swissmedic has confirmed that, although the structure of the new EU legislation has changed, the underlying GMP requirements remain largely unchanged.
Read more
EU: Annexes 4 and 5 no Longer Included in the EU GMP Guide
News

EU: Annexes 4 and 5 no Longer Included in the EU GMP Guide

Following the entry into application of Commission Implementing Regulations (EU) 2025/2091 and (EU) 2025/2154 on the principles and guidelines of Good Manufacturing Practice (GMP) for veterinary medicinal products and active substances for veterinary medicinal products on 16 July 2026, the European Commission removed Annexes 4 and 5 from the EU GMP Guide.
Read more
EMA: Revision of Annex 15 Delayed
News

EMA: Revision of Annex 15 Delayed

In February 2026, the EMA published a concept paper on the revision of Annex 15 "Qualification and Validation" of the EU GMP Guide (we reported previously). The Agency has now released a corrected version containing a significantly revised timetable.
Read more
EU: Updated Q&A on Safety Features for Human Medicinal Products
News

EU: Updated Q&A on Safety Features for Human Medicinal Products

The European Commission has published Version 22 of its Questions and Answers on Safety Features for Medicinal Products for Human Use.
Read more
EMA: Q&A Paper on Measures to Prevent Microbial Contamination of Non-Sterile Medicinal Products
News

EMA: Q&A Paper on Measures to Prevent Microbial Contamination of Non-Sterile Medicinal Products

The EMA has published a new Q&A paper on technical and organisational measures to prevent microbial contamination of non-sterile medicinal products.
Read more
Why is import authorisation necessary for medicinal products entering the EU?
Question of the Week

Why is import authorisation necessary for medicinal products entering the EU?

Here's the answer:
Read more
When APS Fail and First Air is at Risk
LOGFILE Feature

When APS Fail and First Air is at Risk

At the PDA Good Aseptic Manufacturing Conference 2026, Alberto Gonzales (Takeda) discussed challenges and practical solutions related to aseptic process simulations (APS). Anna Campanella (Takeda) and Hussein Bachir (Franz Ziel) explored how first air protection in aseptic processing can be compromised by equipment design, glove interventions, and operator activities.
Read more
FDA: Updated Compliance Program for Preapproval Inspections
News

FDA: Updated Compliance Program for Preapproval Inspections

The FDA has revised its Compliance Program 7346.832, “Preapproval Inspections”. The updated program describes the planning, conduct and evaluation of preapproval inspections (PAIs) for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
Read more
WHO: Draft on Regulatory Ovesight of Disposal of Medical Products
News

WHO: Draft on Regulatory Ovesight of Disposal of Medical Products

WHO published a draft consultation document on regulatory oversight of disposal of medical products throughout the lifecycle.
Read more
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