We would like to celebrate the second anniversary of biosafety4u.berlin GmbH with you: every Sunday in Advent, we will share a useful document – free of charge and with no strings attached.
Since the 19th century, Advent calendars in various forms have counted down the days until Christmas Eve. One of the simplest is the Advent wreath made of fir branches – originally with a candle for every day of Advent, today with just one candle for each Sunday.
In keeping with this tradition, we are delighted to offer you a document to download every Sunday in Advent.
You may use the files as you wish, without restrictions. We will not ask for any personal information, and no registration is required.
We hope you find the documents useful for your facility. If you would like more of them, please send an email to service [at] biosafety4u.berlin.
Wishing you a joyful Advent season, filled with peace, purpose, and plenty of valuable resources to support your work!
First Sunday of Advent – 1 December 2024
We hope you enjoyed the Word template and found it useful: "Appointment of a Biological Safety Officer (BBS) in accordance with Section 29 of the Genetic Engineering Safety Ordinance (GenTSV)".
Too late? Sorry you missed this Advent gift – perhaps next year. If you are interested in this template or any of our many others, we look forward to hearing from you at service [at] biosafety4u.berlin.
In Germany, genetic engineering facilities are built around three key roles: the operator, the project leader and the Biological Safety Officer (BBS).
While the duties of operator and project leader can be held by the same person, the BBS must always remain independent – especially when you engage an external BBS for your genetic engineering facility.
Use the template to appoint an external BBS and submit it to your supervisory authority together with the notification or registration documents.
Note: the template includes text passages provided by a supervisory authority.
Second Sunday of Advent – 8 December 2024
We hope you enjoyed the Word template and found it useful: "GLP QA Assessment Audit Report and GLP Quality Audit Certificate".
Too late again? We’re sorry you missed this Advent gift, too – hopefully there will be another chance next year. If you’re interested in this template or any of our others, feel free to contact us at service [at] biosafety4u.berlin. We look forward to hearing from you!
Quality assurance assessment in accordance with OECD GLP advisory document No. 23 „Quality Assurance and GLP“ ENV/CBC/MONO(2022)20, 4 November 2022, section 12.3. "QA and assessment by third parties".
A GLP test facility or test site may be subject to inspections or assessments requested by third parties. Such external inspections may be required, for instance, by sponsors or by local regulations, and in most cases include an assessment of the GLP compliance of the on-site QA programme.
We use this template to document and report non-conformities found during a GLP assessment of a test facility’s or test site’s QA programme, and to propose corrective actions.
Third Sunday of Advent – 15 December 2024
We hope you enjoyed the Excel template and found it useful: "Risk-Based Quality Management Plan - Critical-to-Quality (CtQ) Factors and Their Associated Risks". The Excel spreadsheet was available for download for a limited time. Please get in touch if you are interested.
According to the ICH E6(R3) Good Clinical Practice (GCP) guideline, section 3.10., the clinical trial sponsor should have measures in place to identify, evaluate, control, communicate, review and report risks to trial participants’ rights, safety and well-being, as well as risks to trial data integrity and reliability.
Sponsors are encouraged (a) to build quality proactively into all aspects of the trial for which they are responsible and (b) to identify factors that are critical to quality (CtQ) and the risks to those CtQ factors (ICH E8(R1) General Considerations for Clinical Studies guideline, section 3.0.).
You can use this Excel template to categorise your CtQ factors throughout the trial life cycle and assign the relevant risks to each factor.
Note: overall responsibility for the trial remains with the sponsor (ICH E6(R3), Section 3.9.). The "sponsor oversight includes [...] quality control and assurance measures specifically customized to the clinical trial and its critical to quality factors and identified risks." (ICH GCP E6(R3) Annex 2, section 3.8.). This template can therefore also be used as an annex to the sponsor’s oversight plan for a specific trial, where such a plan exists.
Fourth Sunday of Advent – 22 December 2024
What a pity you didn’t get the chance to download this Word template in time: "Flowchart for the intended genetic engineering work (Form GA)", a template for drawing up a quick flowchart in accordance with DIN 66001:1983-12 / ISO 5807:1985-02."
Flowcharts make it easy to represent complex processes visually in a single image. As a standardised way of documenting workflows, process models are also required for certification to DIN EN ISO 9001:2015.
There are suitable tools such as Lucidchart, Microsoft Visio or Adobe Express for creating organisation charts, process diagrams and flowcharts – but if you need a quick and easy solution, you are welcome to use our template.
When notifying genetic engineering work at safety level 2, you must describe the work in Form GA for submission to the competent authority. A flowchart makes it easy to see which process steps involve GMOs and which do not.
We wish you a Merry Christmas and a happy start to 2025.
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