Quality assurance programmes increase efficiency and effectiveness – and save work. Forms and standard operating procedures (SOPs) create transparent, reproducible processes: for your internal workflows, for your clients' monitoring and for the supervisory authorities.
Application forms for genetic engineering – easier to fill in
The German Federal/State Working Group on Genetic Engineering (LAG) provides application forms accepted by the authorities of all federal states. In the locked form mode, however, copying text blocks or images is hardly possible. We offer identical forms in Microsoft Word with more functionality: paste text modules, images and flowcharts directly, track changes and add comments – indispensable for teamwork.
- OriginalForm GA (details of the intended genetic engineering work) on the LAG Gentechnik website.
- Identical copyForm GA (Word) – download
- With extended functionalityForm GA by biosafety4u.berlin GmbH (Word) – free download
Can't find the form you need? We create it for you – all forms needed to get started are also available in English.
GLP, GCLP and GCP
Planning to implement your own quality assurance programme, revise SOPs or prepare for an inspection? We look forward to learning about your requirements.
Good Laboratory Practice (GLP) quality services
Good Laboratory Practice (GLP) is an officially monitored quality assurance programme for non-clinical testing and characterisation of new compounds. The test item is in focus – be it a drug substance, a drug product, a herbicide or pesticide, or a food additive.
biosafety4u.berlin helps you implement a GLP quality assurance programme – whether you start from scratch or transform your current QA programme towards GLP. Download our GLP implementation flowchart (PDF).
Benefit from a GLP QA programme evaluation
- if you are a study sponsor with limited capacity for GLP test facility qualification;
- if your GLP monitoring authority expects you to evaluate the effectiveness of your QA programme regularly, as described in OECD GLP document No. 23 “Quality Assurance and GLP”, section 12.3 “QA and assessment by third parties”.
We also support you with GLP competence training including knowledge quizzes (on site or remote), SOP revisions, interim QA (e.g. parental-leave cover or peak workload) and preparation for audits and inspections.
All services are based on the OECD Principles of Good Laboratory Practice. National law and advisory documents of GLP monitoring authorities may add requirements – for example on archiving periods. We help you identify the documents relevant to you.
Good Clinical Laboratory Practice (GCLP) quality services
Good Clinical Laboratory Practice (GCLP) describes a laboratory framework for the confidentiality and safety of clinical trial participants in line with Good Clinical Practice (GCP). Trial samples collected from participants are in focus.
biosafety4u.berlin conducts GCLP facility audits and issues a GCLP Quality Audit Certificate. Download our GCLP audit process flowchart (PDF). We add value to your existing ISO quality system and bring your QA documents and processes in line with GCLP.
- for clinical trial sponsors with limited capacity for laboratory vendor qualification;
- for laboratories analysing clinical trial samples that need an external statement of competence for RFP responses – an independent certificate can save time and costs for everyone involved in recurring sponsor audits.
Also available: GCLP training (on site or remote), SOP revisions and preparation for audits and inspections.
Regulatory basis:
- ICH E6(R3) Guideline for Good Clinical Practice (current version);
- EMA Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples, EMA/INS/GCP/532137/2010;
- WHO Good Clinical Laboratory Practice (GCLP), 2009, ISBN 978 92 4 159785 2;
- EMA Guideline on computerised systems and electronic data in clinical trials, EMA/INS/GCP/112288/2023;
- EMA Annex II to guidance for the conduct of GCP inspections – clinical laboratories, EMA/399244/2016.
Further publications by non-governmental organisations may summarise GCLP expectations, but are not binding.
“The competent GCLP audit process with its open-minded and hands-on atmosphere has confirmed compliance and helped us preparing for clinical trial sponsor audits. The GCLP evaluation definitively adds a valuable feature for our clients and FyoniBio.”
Good Clinical Practice (GCP) quality services
Services around the ICH Good Clinical Practice (GCP) framework are in preparation. Please feel free to ask us in the meantime.
