Quality System and Regulatory Affairs
Biological Industries is committed to providing products and services that meet all specifications and we are driven to surpass our customer’s expectations. BI places the integrity of our employees and products in the forefront for the safe manufacture, distribution and conduct business in compliance with all environmental, government and other relevant regulations.
As a manufacturer for the life science industry, BI is fully committed to the current Good Manufacturing Practices (cGMP) comprising the internal GMP policy as well as local law and international guidelines adopted by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). BI’s quality systems comply with the international standards for Quality Management Systems as defined by the ISO 13485:2003 and routinely audited by an accredited external body. Our manufacturing facility is a ISO 9001:2008 and ISO 13485:2003 certified facility and our controlled environment clean rooms are graded from ISO 8 up to ISO 5 (classified from class 100,000 to 100). Our products are divided into two groups: For Research Use Only and For In Vitro Diagnostics.
Products for research use are mainly those intended for molecular biology and others that are not included in the “In Vitro Diagnostics” category. These products are prepared according to the requirements determined by Biological Industries.
The products for In Vitro Diagnostics are produced according to the “In Vitro Diagnostics Directive 98/79/EC of the European Parliament. Products that are marked CE are marked for In Vitro Diagnostic Use. These products are considered medical devices, but are also suitable for research use and as raw material components in further manufacturing processes. Declarations of Conformity for in vitro diagnostic products are available upon request.
A DMF is available for NutriStem® hPSC XF and for the MSC NutriStem® XF Basal and Supplement. The DMF is an act of risk reduction activity, which brings us a step closer for your product clinical qualification. NutriStem® hPSC XF and MSC NutriStem® XF are considered in regulatory aspects as an "Ancillary Material" meaning; a material used in the process but is not part of the final product.
The USP defines the requirements of ancillary materials in a general monograph USP Ancillary Materials for Cell-,Gene-, and Tissue-Engineered Products. In accordance to the USP Risk classification (4 tiers), the product is characterized as low- risk. Permission to cross-reference the Master File may be obtained by sending us an LOA request letter in accordance with the instruction in the document Requesting Letters of Authorization. Please contact us to request the letter.
BI holds certification from the EDQM (European Directorate for the Quality of Medicines), which allows our sterile fetal bovine serum to be used in the production of drugs. Certification is available upon request.
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Safety and Adverse Events
We monitor the safety of our products at discovery, during development and during the manufacturing process. We encourage reporting of adverse events by contacting our Global Quality and Regulatory Team at BI at +972.(0)4.9960595 or email email@example.com.