Public Consultation

In 2019, FAMI-QS carried out a systematic review of the Process Document Bioprocess (PD-Bioprocess). The systematic review of the PD-Bioprocess was triggered by the latest regulatory developments in the European Union, at that time, in regard to the authorisation of ingredients obtained from bioprocessing.
Following extensive discussions and an exchange of collective experience, knowledge, and expertise at global level among the members of the Task Force (TF) Bioprocess, the PF Bioprocess was revised in order to respond to and address the emerging challenges relating to bioprocess. The collective work of the TF Bioprocess is presented in the below document. On behalf of FAMI-QS, we would like to thank all the members of the TF for their commitment and support.
Objective of the revision
To address all the known hazards/risks relating to bioprocess and manage these hazards/risks under the current methodology of HACCP. The management of these risks and the content of the preventive or control measures may differ from region to region, taking also into consideration the different regulatory/statutory background. In line with the FAMI-QS Requirements, hazards/risks shall be treated always based on the regulatory/statutory requirements where the FAMI-QS Certified Organisation is located and the regulatory/statutory requirements of the country of destination.
Why Process Documents are important for the FAMI-QS Certification Scheme
Following the revision of the FAMI-QS Certification System and the launch of the FAMI-QS Code of Practice Version 6.0, our scope adapted to reflect the worldwide implementation of the system. With the scope Specialty Feed Ingredients, we refer to any production and trade of single ingredients and/or their mixtures coming out of one of the following production processes or a combination thereof, for which our sector maintains a high level of expertise: Bioprocess, Chemical, Extraction, Mining and Mixing.
The Process Documents act as an add-on to the FAMI-QS Code for the implementation of the requirements addressed within the FAMI-QS Code Version 6.0 §8.7. HACCP Programme. Specific to each process, each document provides a hazard/risk assessment framework consisting of specific guidelines for managing the hazards/risks associated with each process. In addition, the Process Documents are part of the final FAMI-QS auditors’ scope approval.
The consultation for the Process Document Bioprocess will remain open until 2020-09-30. We invite you to share with us your comments on the document by using this template.
For the submission of the comments please use the following email address:
Feel free to share this information with colleagues or any other partners in the feed chain.
Comments evaluation
Once the consultation period has concluded, the FAMI-QS Secretariat will compile the comments received in one document. Following an initial review of the comments by the FAMI-QS Secretariat, the TF Bioprocess will assess the content and provide feedback on each comment. Once this process has been completed, the comments with the responses provided by the TF will be made available on the FAMI-QS Website for a period of two (2) months. In the event that there will be comments that may have a significant impact on the document, the document will be submitted for a short comment period of thirty (30) days.