A 5-batch Q&A session with Sandra Penzkofer, EAS Group Business Development, Europe
In this short Q&A, Sandra Penzkofer addresses some of the questions frequently asked in regards to 5-batch studies…
When do you need to carry out a 5-batch study?
While there are many possible scenarios, the most likely is when registering a new biocide or plant protection product, because there is no existing data on the quality of your production process. 5-batch analysis may also be required when an applicant intends to register a new source of active ingredient or a new production site for instance.
In addition, a 5-batch study may be required for a re-registration – unless you can provide complete QA data for all analytes of interest from your last registration process onwards. If your substance has potential exposure to humans and to the environment, a 5-batch study may be needed to comply with European REACH regulations.
Eurofins Agroscience Services 5-batch specialists are based at key laboratory locations around the world, ready to support you with your project. We can support in terms of the data generation, with our in-house regulatory team on hand to provide the study monitoring. Eurofins Agroscience Regulatory can also provide dossier preparation, submission to and follow up with the competent authorities up until you receive the outcome from evaluators.
What does the process for a meaningful 5-Batch Study look like?
The process will vary slightly depending on your substance and the level of support required throughout production, but the basics are similar. Here are the steps for a successful 5-Batch Study:
1) Examination of the production process, stoichiometry and the exclusion of relevant impurities
2) Laboratory pre-screening of impurities
3) Method validation for the active and relevant / significant impurities
4) Execution of a 5-Batch under GLP rules
You can maximise timelines and optimise your production process by getting your 5-Batch Study properly designed and evaluated upfront. Eurofins Agroscience Services will work with you to ensure the most effective approach is applied to your study.
Is there anything specific I should look out for during a 5-Batch study?
One important factor to keep in mind throughout a 5-Batch study is the stability of your product.
Stability considerations begin when sending samples. Products which can easily evaporate, such as the production additive propanol, need to be well packaged to stay in solution. Other products might degrade under wrong storage conditions or study length.
At Eurofins Agroscience Services, we make sure that we observe the stability of your product over the course of our examination at ongoing basis, to make sure you get a robust and true outcome.
What should I consider when planning for a 5-Batch study?
Whilst there are many scenarios that may require a 5-batch study, EAS Group works with you to tailor our service for optimal results with two important considerations:
1) Reference standards: can you supply reference substances? If not, can you recommend where we should buy them? We want to ensure we use the same quality of reference material as you.
2) Validated methods: do you have validated test methods available to share? Do you have any specific requirements or recommendations regarding which equipment to use? As all equipment has its own specifics, it is desirable to use the same kind for optimal reproducibility.
Our experts are constantly adapting their approach in order to make your project run more smoothly, be most cost-efficient and adapt to best practice examples.
Another thing to consider is that the batches to be analysed should represent the production process and therefore, its slight variability in purity and impurity content. Supplying only the best production samples will lead to problems later, as production cannot consistently match with the representative test results from the 5-Batch study.
In summary, EAS Group can work with you to make your 5-batch study a success.
All of our 5-batch studies begin with the same three steps:
- examining possible impurities via stoichiometry;
- screening impurities by chemical analysis;
- and individual method validation.
We will adjust these processes to suit your individual compound / formulation and to allow for any background knowledge you are able to share with us. If impurities are already well known and method validation has been carried out, significant savings can be made on both the time and cost needed to perform your study.
EAS Group has many years of experience in performing 5-batch studies and providing regulatory consultancy – please contact Sandra Penzkofer for more details. If you have any specific questions – she would be happy to help!
