ND 4 FOOD
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On Quality Assurance & Control Risk Management

Food additives in the sense of the Food Laws are substances that, by being used in food production, achieve certain technological effects and thus influence these foodstuffs in terms of their properties. As to whether any particular substance may be defined as a food additive, ND Pharma & Biotech Company refers to the official regulations governing food additives, ingredients and other substances able to be incorporated in the manufacturing of foods, foodstuffs, supplements, medical foods, complements, special nutrition, hospital nutrition, etc.
We follow this QA System in all our plants, own, operated and those pertaining to partners worldwide, so our products are guaranteed under such Quality Assurance and Quality Control Systems and Procedures. In addition, practically all of our production sites have Private Audit Certifications, as ISO, IFS, BRC, FamiQs, EQM, and others from worldwide and internationally recognized organizations and certification companies.
All our production sites are under Strict Official Control and Registered with the Competent Authorities relevant to the territories and countries where those sites are allocated.


HACCP guidelines 
European Regulation 852/2004/EC regulates the general hygiene of foodstuffs at all stages of the production chain to ensure hygiene and hence safety of foodstuffs. It requires the manufacturer to establish specific internal control measures and documentation based on the HACCP concept (Hazard Analysis and Critical Control Point) introduced by the FAO/WHO Codex Alimentarius. The HACCP concept includes active control of the processing steps and the working procedures.
Since counter-measures to be taken in any specific case are documented individually for each control point and personnel responsibilities are clearly defined, potential dangers and deviations from established standards may be identified in advance. Thus it is possible to solve problems at the first indication, before they can exert any influence on the safety or quality of the product involved.


Good Manufacturing Practices – GMP and GMP Compliance 
GMP and GMP compliance as practiced at ND Pharma & Biotech Company comprise several additional aspects, such as the design of the product, its traceability, the release analysis and the comprehensive documentation of all procedures. The quality assurance system is based on risk management for technical systems and production plants, qualification of plants, control of processes, cleaning procedures and analytical methods. Microbiological monitoring of the demineralized water used and, if necessary, the production plant itself, the rooms used and the personnel involved is also carried out. All of our plants staff are properly qualified and correspondingly trained in the use of the equipment involved. All steps of the working procedure are individually documented in SOPs. In-process controls are carried out to monitor and control all production steps. The final products are subjected to analysis of the predefined specifications before being released.
Essential goals of our GMP philosophy are the exclusion of mix-ups in all production steps up to and including the final product and the avoidance of all biological, chemical and physical contamination.
Our quality assurance system is regularly monitored and audited by the corresponding authorities.
Since 2012 we have been Registered and open to inspections by the FDA (the US Food and Drug Administration). Regarding the production of medicinal products, we are regularly inspected by the Competent Authorities. So far without any major complaints. ND Pharma & Biotech Co. high quality and safety is also confirmed by annually audits carried out by our customers in the pharmaceutical, cosmetic and food industries.