GMP Publications

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.

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.

E-Learning GMP:READY | Specialist Knowledge GDP Compact

Are you looking for a way to train yourself or your colleagues sufficiently? 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.

Annex 1: What's new? – A Comparison from Draft to Final

The final version of Annex 1 (2022) of the EU GMP Guide, titled "Manufacture of Sterile Medicinal Products", has kept many responsible persons busy. Do you also ask yourself: What has been changed? Am I well prepared? What action do I have to take? Also included in the comparison file are: A comparison of the currently still valid version from 2008 with the draft document of 2017 A comparison of the draft documents from 2017 to 2020 This makes it easy for you to track all the development steps that led to the final version in 2022. A criticality index (1–3) is used to evaluate the various changes. With this download, you receive the comparison not only as a PDF but also as an editable MS Excel file. You can use the format that helps you best.

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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.

Evaluation of the environmental risks of medicinal products (free guideline)

Why Do You Need an Environmental Risk Assessment? Nowadays, the application for placing a medicinal product for human use on the market requires an environmental risk assessment report. This report must be based on the instructions of the EMA's Guideline on the Environmental Risk Evaluation of Medicinal Products for Human Use (Doc. Ref. EMEA/CHMP/SWP/4447/00 corr. 2). How to Obtain an Elemental Impurities Risk Assessment The proven and successful collaboration between Azierta and GMP-Verlag Peither AG provides you with an economically priced alternative to conventional elemental impurities risk assessments. Following verification of the critical key data, we will be pleased to send you a binding, fixed price quote. What You Get With Us We provide comprehensive reports for the analysis and assessment of possible environmental risks of an API: Evaluation procedures based on the current EU guideline: EMEA/CHMP/SWP/4447/00 corr 2. Phase I: Estimation of exposure Phase II: Environmental fate and effects analysis Risk Assessment for each API using the latest version of the IQVIA database. Specialised environmental toxicologists with extensive experience in new drug registrations. Information Required for a Fixed Price QuoteTo prepare a binding, fixed price quote, please provide the following information: Company name and address Name of the medicinal product Country in which the product is to be sold Maximum daily dose

How to implement ICH Q3D of elemental impurities in 5 steps (free manual)

Why do you need an elemental impurities risk assessment?As of June 2016, all new medicinal products have to be evaluated based on the ICH guideline Q3D on elemental impurities. As of December 2017, this guideline came into effect for already authorised medicinal products as well. Therefore, every authorised medicinal product has to be evaluated.How to obtain an elemental impurities risk assessment? The proven and successful collaboration between Azierta and GMP-Verlag Peither AG provides you with an economically priced alternative to conventional elemental impurities risk assessments. Following verification of the critical key data, we will be pleased to send you a binding, fixed price quote. Our service includes: Issuing of the elemental impurities risk assessment according to ICH Q3D guideline in English issued for the specific medicinal product according to ICH Q3D guideline issued by European toxicological experts This is what we need from you to prepare a binding, fixed price quote Company name and address Name of the medicinal product Completed questionnaire

GMP:KnowHow Pharma Logistics (GDP) | Free Demo Access

Your perfect tool for GDP-compliant storage and transportation The demo access is free and absolutely non-binding. It ends automatically after 7 days. How the GMP:KnowHow Pharma Logistics (GDP) supports you: Practical Knowledge Here, the respective GDP chapter is summarized and interpreted in simple terms. In particular, the practical implementation at a logistics service provider is considered in the interpretation. You also receive many editable sample documents. By the way – you can always ask our experts: Ask your specific questions directly form the online portal. Receive personal answers. Regulations All relevant GDP regulations are covered and are always up-to-date. You will find all relevant passages from the various pieces of legislation that have been assigned to the respective GDP chapter. This gives you a direct overview of the underlying regulatory requirements for each topic.

OEL Categorisation | Sample Document

Why do you need OEL categorisations? For every API, an upper limit on the acceptable concentration in workplace air has to be determined (OEL). For this determination, toxicological and pharmacological properties of the API are analysed and related to preventive measures.Our service includes extensive bibliographic researchOEL determination according to internationally accepted guidelines Categorisation with regard to the specific working conditions according to national requirements or SafeBridge® banding scheme This is what we need from you to prepare a quote Company name and address Name of the API

PDE Report | Sample Document

Why do you need a PDE report? As of June 1st, 2016, health-based exposure limits must be determined for all APIs of human and veterinary medicinal products produced in multi-purpose facilities. >>> More information Our service includes Issuing of the PDE report According to EMA guideline in English Issued on your company name according to EMA guideline requirements Issued by European toxicological experts Brief explanation/training of the report 10–15 minutes in English Conducted by a toxicologist via Skype after delivery This is what we need from you to prepare a quote: Company name and address Name of the API Dosage form Route of application of the API or of the potential next product produced in the same facility (for cleaning validation)

Elemental Impurities Risk Assessment | Sample Document

Why do you need an elemental impurities risk assessment? As of June 2016, all new medicinal products have to be evaluated based on the ICH guideline Q3D on elemental impurities. As of December 2017, this guideline came into effect for already authorised medicinal products as well. Therefore, every authorised medicinal product has to be evaluated. How to obtain an elemental impurities risk assessment? The proven and successful collaboration between Azierta and GMP-Verlag Peither AG provides you with an economically priced alternative to conventional elemental impurities risk assessments. Following verification of the critical key data, we will be pleased to send you a binding, fixed price quote. Our service includes Issuing of the elemental impurities risk assessment According to ICH Q3D guideline in English Issued for the specific medicinal product according to ICH Q3D guideline Issued by European toxicological experts This is what we need from you to prepare a binding, fixed price quote Company name and address Name of the medicinal product