18 min. reading time | by GMP Verlag Peither AG Published in LOGFILE 13/2021
Today’s feature focuses on GMP risk analysis. It is an excerpt from the E-Learning GMP:READY – GMP for Engineers. GMP:READY provides knowledge for the planning, qualification and maintenance of the pharmaceutical equipment and facilities.
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FDA: Updated Pre-RFD Guidance for Combination Products
The U.S. FDA has released an updated final guidance on preparing a Pre-Request for Designation (Pre-RFD),
replacing the previous 2018 version. The revised document provides new
recommendations for interacting with the Office of Combination Products
(OCP) and clarifies expectations for Pre-RFD submissions.
EDQM: 9 Virtual Training Modules on Ph. Eur. and CEPs
The EDQM has introduced a modular training programme covering chemically
defined active substances and medicinal products. It will take place
between 1 and 12 December 2025.
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.
Ready for dispatch, Delivery time appr. 2-5 workdays (2-3 weeks for christmas goodies)
GMP:KnowHow Pharma Logistics (GDP) | Named User License | 12M
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.
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E-Learning GMP:READY | GMP for Engineers Online Course
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.
Ready for dispatch, Delivery time appr. 2-5 workdays (2-3 weeks for christmas goodies)
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.
Ready for dispatch, delivery immediately after receipt of payment
