In urban areas and, later, in rural areas, where, for the usual analyzes, uncomfortable distances were covered, private laboratories have been set up and authorized, since 1992, to focus on physico-chemical and biological analyzes, including food. or machinery and work surfaces in the food industry. The sanitation tests on the packaging completed, from the first stages, the area of services offered by private laboratories. Legislative changes and increasingly precise regulations on the circulation of products on the market and the protection of consumer health, have led to an increase in the number of customers who turn to these laboratories. At the same time, the pressure of demand for new determinations, imposed by new foods, has increased. Made on the basis of some, just like us,
At the beginning with the State
In July 2010, the first private laboratory received the sanitary-veterinary and food safety authorization, based on the new Order of the President of ANSVSA (no. 48/2010). Until then, private laboratories operated under the authorized authority of the Ministry of Agriculture, the Institute of Hygiene and Public Health or the late Office for Consumer Protection. From the very beginning, any private laboratory, which addresses the manufacturing units, warehouses, importing units or food marketing units, has registered its services in the area, drawn by attributions, tests, and experience, by LAREX – National Center for Product Testing and Expertise. Public institution with legal personality, since 1990, now fully financed from extra-budgetary funds, CNIEP – LAREX operates under the authority of the National Authority for Consumer Protection. Recommending a neutral body, notified by Government Decision, LAREX organizes courses for professional development of staff in physical and chemical laboratories. He is also a founding member of the Romanian Accreditation Association (RENAR), whose opinion gives weight to any private laboratory in the business card.
Self-assessment, assessment, authorization
According to strict economic calculations, the business of opening a laboratory can start leaving in the file of theories the possibility of supporting the first steps, with funds coming from the blue horizons. Before starting, in the space of your own laboratory, the provision of technical testing and analysis services, in the sanitary-veterinary field and for food safety, a realistic self-assessment is required. And this is because the evaluation that will precede the issuance of the authorization will be made as rigorously as possible. The evaluation commissions include representatives of the Directorate for Technical Coordination of Reference Institutes, LSVSA, pharmacovigilance and animal nutrition and – depending on the area of activity covered by the potential laboratory – representatives of the specialized departments within ANSVSA and specialized personnel within the veterinary institutes / reference laboratories. After this estimate, the commission prepares the evaluation form and the evaluation report, documents based on which the director of the technical coordination department of the reference institutes, LSVSA, pharmacovigilance and animal nutrition or, as the case may be, the executive director of the county DSVSA, respectively of Bucharest, issues the operating license. The authorized sanitary-veterinary and food safety laboratories have the obligation, subsequent to the authorization, to notify, in emergency regime, to the competent authority that issued the operation authorization, the results of laboratory tests not in accordance with the legislation in force, for samples of products intended for the final consumer, which may pose a risk to public or animal health. The personnel within the competent authority is obliged, based on the principle of confidentiality, to ensure and adopt data protection measures regarding the units involved, during the entire period until the confirmation of the laboratory results.
Operation – mandatory general conditions
The sanitary-veterinary and food safety laboratories are required to meet the general operating conditions and to participate annually in intercomparison tests, organized by the profile reference laboratories or by the sanitary-veterinary and food safety laboratories within the veterinary institutes. For the research institutes, which do not issue analysis bulletins, the maximum score established in the evaluation form for intercomparison tests and trainings is granted, specifying in the sanitary-veterinary authorization that they do not have the right to issue analysis bulletins.
The general operating conditions, fulfilled prior to the authorization by the sanitary-veterinary and food safety laboratories, refer to: location conditions, construction conditions and utilities conditions.
When establishing the specific operating conditions, for the authorization of the laboratories it is verified if:
– they have reagents, sets for laboratory activity, culture media, specific materials, laboratory consumables;
– the consumption of reagents, the culture media, its specific materials are adequate to the analytical methodology applied and are also correlated with the volume of samples analyzed;
– the endowment with equipment and instruments ensures, in optimal conditions, the analytical capacity and the development of the analytical flow.
The specific operating conditions listed in the normative acts, mandatory and necessary conditions for a laboratory, concern the work spaces / annexes, the staff and documents / records.
For the laboratory, work spaces are needed in which to avoid the intersections of analytical flow of samples and activities, depending on the specific. At the same time, the administrative spaces intended for laboratories where activities with biological risk are carried out should be clearly delimited by the places where specific laboratory activities are carried out.
The staff necessary for this activity is composed of the head of laboratory and / or specialist with higher education in the field, technical staff with secondary education and auxiliary staff. The training of the personnel of the sanitary-veterinary and food safety laboratories is carried out based on the national training program, according to the legislation in force.
The documents to be kept by private laboratories are: the register for receiving samples, the workbook / worksheets, the records / records / use of reagents, standards, culture media, etc., the files on the use and maintenance of the equipment, the sheets on temperature monitoring and humidity (where applicable), minutes of collection of samples for analysis and analysis bulletins (issued according to the models imposed by the reference institutes), sheets on hazardous waste management, archive. The evidence of the documents, in the sanitary-veterinary laboratories and for food safety, is kept for at least three years.