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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EMA Clarifies Batch Numbering for Parallel-Traded Medicines
EMA updated its GMP/GDP Q&A collection by revising the
answer to Question 4 concerning Chapter 5 of the EU GMP Guide. It explains
which batch numbers should appear on the packaging of parallel-traded
medicines.
Cleaning Validation: When PDE Reports and the Worst-Case Selection do not Align
Robust PDE reports form the basis of risk-based cleaning validation. This article highlights common deficiencies identified during GMP inspections and explains how they can be avoided.
EDQM: New Working Party on 3D-printed Medicinal Products
The European Pharmacopoeia Commission (EPC) approved the creation of a working party on 3D-printed medicinal products. Its aim is to support the development of appropriate quality standards in the European Pharmacopoeia (Ph. Eur.).
Appendix 1 of EMA’s Questions and Answers on nitrosamine impurities has been updated. This appendix contains acceptable intakes (AIs) established for N-nitrosamines.
WHO: Draft Revision of its Guidelines on Quality Risk Management
WHO published a revised draft of its “WHO guidelines on quality risk management”. Working document QAS/26.994 is open for public comment until 15 November 2026.
With an named user licence, one user can access the knowledge portal; with a corporate licence, any number of users can access it.Approx. 5,000 pages of practical GMP knowledge with illustrations and forms: Practical guidance for rapid implementation in the workplaceDetailed descriptions of GMP-compliant systemsInternational laws and guidelines Always up-to-date thanks to regular updates
Download Advantages and Prices60+ Sample Documents In addition, the GMP Compliance Adviser contains more than 60 sample documents (MS Office) and practical examples that you can use.Sample SOPsSample FormsSample ReportsSample DocumentationChecklistsProcess Diagrams (Flowcharts)Practical Examples of QRM Application (e.g., Risk Analyses)Sample Documents for Qualification and ValidationCase StudiesWritten by more than 80 authors with hands-on experience directly linked to the industryA team of over 80 experts interpret regulatory requirements and describe how they are implemented in practice.The authors are experienced in the pharmaceutical industry, consulting, and government agencies.
GMP:KnowHow Pharma Logistics (GDP) | Named User Licence | 12M
Your knowledge portal for GDP-compliant pharmaceutical logistics.
It is important that you as a logistics service provider, but also as a client in the pharmaceutical industry, comply with regulatory requirements. The GMP:KnowHow knowledge portal guides you through the complex regulatory landscape of the pharmaceutical and logistical supply chain! The knowledge portal gives you an easy-to-understand overview of all the important topics. Interactive graphics help you navigate all 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 valuable research time.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?
GMP:KnowHow Pharma Logistics (GDP) is a practical knowledge portal dedicated to Good Distribution Practice (GDP). 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, currently Director Quality at Fisher Clinical Services, previously served as Head of Quality Control and Responsible Person (GDP) for the Grieshaber Group. She is also a long-standing author and GDP expert at GMP-Verlag.
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
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.
