quality control
Natieco has a quality control laboratory essential to ensure that the materials used for processing and the finished product comply with the standards of quality, safety and effectiveness.
The QC department, through operational procedures, controls all incoming materials such as packaging and raw materials, which only after approval are included in the production processes. During the processing, in addition to the in-process controls, provided for by the good manufacturing standards, the semi-finished product is subjected to checks to determine its conformity according to pre-established specifications. At the end of the production, some random samples of the lot are subjected to chemical-physical and microbiological investigation in order to issue the certificate of analysis (AOC) establishing compliance with the resulting batch release certificate issued by our QP (Qualified person).
The quality control laboratory also has the important role of daily monitoring the parameters of the PW water used for production processes, which must maintain quality standards by Pharmacopoeia.
In the development of projects together with the research team, the quality control follows the Stability studies of product Stability by subjecting them to thermal stress and analytical protocols to establish their long-term compliance and shelf life.
useful answers
It is a document issued for each production batch in which all the analytical specifications (chemical-physical and microbiological) that certify conformity and approve the subsequent release on the market are reported.
To ensure that each batch has been produced and checked in compliance with the necessary requirements, before being placed on the market.
Microbiological investigations are aimed at the research and identification of microorganisms (bacteria, moulds, yeasts and viruses) and their quantitative evaluation (counting). Controls that we carry out both on raw materials and on each finished product, very important criterion in order to ensure that the products placed on the market are safe.
The quality of water for human consumption is regulated by Legislative Decree No. 31 of 2001, which transposes Directive 98/83/EC and which applies to all water intended for drinking, food and beverage preparation. We at Natieco srl have chosen to exceed the standards of the minimum requirements of health and physical, chemical, microbiological quality , ensuring for the production and sanitizing processes plants a water quality having pharmaceutical standards.
