We would like to celebrate the two-year anniversary of biosafety4u.berlin GmbH together with you - every Sunday in Advent we will provide you with a useful document - free of charge and completely barrier-free.
Since the 19th century, Advent calendars have been very common in various forms to indicate the number of days left until Christmas Eve. The simplest form is an Advent wreath made of fir branches, originally with one candle for each day of Advent, today with only one candle for each Sunday of Advent.
Following this tradition, we are now delighted to provide you with a downloadable document every Sunday in Advent.
You can use the files as you wish, without any limitations. You will not be asked for your personal information, a registration is not required.
We hope you will find the document(s) useful for your facility. If you require more of these, 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 Advent Sunday - 01 December 2024
We hope you had lots of joy and great use for the WORD template: "Appointment of an Biological Safety Officer (BBS) in accordance with Section 29 of the Genetic Engineering Act (GenTSV)".
Running late? Sorry you missed the Advent gift. Perhaps it will work out next year. If you are interested in this template, or any of the other numerous templates, we look forward to your inquiry at service [at] biosafety4u.berlin.
In Germany, genetically engineered facilities are mainly regulated by three elements: the operator, the project management, and the biological safety officer (BBS).
While the tasks and responsibilities of the operator and project management can be handled by a single person, the BBS must always be independent, especially when you contract an external BBS for your genetically engineered facility.
Use the template to appoint an external BBS and submit it along with the notification or registration documents to your supervisory authority.
Note: The template includes text passages that have been provided by a supervisory authority.
Second Advent Sunday - 08 December 2024
We hope you found the WORD template both enjoyable and useful: "GLP QA Assessment Audit Report and GLP Quality Audit Certificate".
Running behind again? We’re sorry you missed out on the Advent gift another time. Hopefully, there will be another opportunity next year. If you're interested in this template or any of our other available templates, feel free to reach out to us at service [at] biosafety4u.berlin. We look forward to hearing from you!
Quality assurance assessment according to OECD GLP No. 23 advisory document „Quality Assurance and GLP“ ENV/CBC/MONO(2022)20, 4 November 2022, section 12.3. "QA and assessment by third parties".
The GLP test facility or test site can be subject to inspections or assessment procedures requested by a third party. These external inspections could be mandated for instance by the sponsors or by the local regulations, and in most cases include GLP compliance assessment of the on-site QA program.
We use this template to document and report non-conformances detected in a GLP assessment of a test facility or test site QA program, and to suggest corrective actions.
Third Advent Sunday - 15 December 2024
We hope you had lots of joy and great use for the Excel template: "Risk-Based Quality Management Plan - Critical-to-Quality (CtQ) Factors and Its Associated Risks". The Excel spreadsheet could have been downloaded earlier. Please inquire 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 design the quality arround all aspects of the trial they are responsible for in a proactive way, (b) to identify factors which could be critical to quality (CtQ), and the risks associated with this CtQ factors once they occur (ICH E8(R1) General Considerations for Clinical Studies guideline, section 3.0.).
You can use this Excel spreadsheet template to categorize your CtQ factors throughout the trial life cycle and to assign risks to each of the factors.
Note: The overall responsibility for the trial remains with the trial 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.). Hence, this spreadsheet template can also be used as an amendment to the sponsor´s oversight plan for a specific trial, if such a oversight plan exists.
Fourth Advent Sunday - 22 December 2024
Too bad you didn´t have the chance to downlad this WORD template in time: "Flowchart for the intended genetic engineering work (Form GA)", a template for generating a quick flowchart according to DIN 66001:1983-12 / ISO 5807:1985-02."
Flowcharts simplify the visual representation of complex processes in a single image. Process models, as a standardized documentation form for workflows, are also a requirement for certification according to DIN EN ISO 9001:2015.
Although there are suitable tools such as Lucidchart, Microsoft Visio, or Adobe Express for generating organizational charts, process flow diagrams, or flowcharts. But if you need a quick and easy solution, you are welcome to use our template.
When notifying genetic engineering activities at safety level 2, the genetic engineering activities must be described in the form GA for submission to the competent authority. A flow chart facilitates orientation, showing which process steps involve GMOs and which do not.
We wish you a Merry Christmas and a pleasant start to the new year 2025.
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