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We are your specialists for food analysis, as well as safety testing of medical devices and pharmaceuticals. Get to know us today.
Your test lab in Rostock
About BIOSERV
As an independent, owner-managed laboratory, BIOSERV Analytik und Medizinprodukte has been successful in the market for more than 30 years. We support you in ensuring the quality of your products.
Our comprehensive laboratory and specialist services are used by regional, national and international customers in the care and health sectors, the food industry, crafts, restaurants and the retail trade.
Accreditations and approvals of our testing laboratory
Legislators, customers and consumers place high demands on the safety of food, medical devices and pharmaceuticals. We are accredited and recognised by the DAkkS and ZLG and continue to work to the criteria of the GLP and GMP quality assurance systems.
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FAQ about the BIOSERV test lab in Rostock
Accreditation according to DIN EN ISO/IEC 17025 is an internationally recognised standard that defines the requirements for the competence of testing and calibration laboratories. This standard defines the general requirements that laboratories must meet to ensure that they are technically competent and deliver valid results. It covers both management and technical requirements.
The management requirements relate to the laboratory’s quality management system, including control of documentation, periodic review and continuous improvement. Technical requirements relate to the competence of personnel, adequacy of facilities and environmental conditions, validation of methods, traceability of measurements and handling of test and calibration equipment.
Accreditation to DIN 17025 offers several benefits. It assures customers and regulators that test and calibration results are reliable and accurate, as the standard requires that all tests and calibrations are performed using validated methods and under controlled conditions. In addition, the results of a laboratory accredited to DIN 17025 are internationally recognised and accepted, which is particularly beneficial for companies operating in global markets.
Another benefit of accreditation is legal compliance. In many industries, companies are required by law to have their products tested by accredited laboratories to ensure compliance with quality and safety standards.
Accreditation to DIN 17025 requires the laboratory to undergo regular audits and assessments by independent accreditation bodies to ensure that high standards are maintained. This leads to a continuous improvement process within the laboratory, further enhancing the quality and reliability of the services provided.
In summary, DIN 17025 accreditation is a quality mark that confirms that a laboratory is technically competent and delivers accurate, reliable results. It reassures customers and regulatory authorities that they can rely on the quality of the tests and calibrations and strengthens confidence in the laboratory’s capabilities at an international level.
A GLP (Good Laboratory Practice) laboratory is a laboratory that operates in accordance with the principles of Good Laboratory Practice, a quality system that regulates the organisational procedures and conditions for non-clinical health and environmental studies. These studies are necessary to assess the safety of chemical substances such as pharmaceuticals, pesticides, food additives, cosmetics and other chemicals.
A GLP testing laboratory ensures that the data generated are reliable and of high quality, which is essential for assessing the safety and efficacy of substances used in human health and the environment. These laboratories operate according to strict international GLP guidelines established by organisations such as the Organisation for Economic Co-operation and Development (OECD), which are often adopted and implemented by national regulatory authorities.
A GLP laboratory uses standardised procedures to ensure that all studies and tests are carried out under controlled and reproducible conditions. This includes the planning of studies, the documentation of all steps and the archiving of all data and samples. Strict documentation is an essential part of the GLP principles and ensures transparency and traceability of all work performed.
A GLP test laboratory is subject to regular inspections and audits by regulatory authorities to verify compliance with GLP guidelines. This leads to continuous improvement of quality standards and ensures that laboratories meet the highest requirements. For companies and institutions requiring GLP-compliant studies, a GLP testing laboratory provides assurance that the study results will be internationally recognised and accepted, which is particularly important for the approval of new products and substances on the global market.
In summary, a GLP testing laboratory is capable of conducting non-clinical studies to the highest standards of quality and safety and ensuring that the data are reliable, reproducible and internationally accepted. This is essential for the development and approval of safe and effective products in various industries.
A GMP (Good Manufacturing Practice) testing laboratory is a facility that specialises in complying with Good Manufacturing Practice. GMP is a quality management system that ensures that products, particularly in the pharmaceutical and cosmetics industries, are manufactured and tested under controlled conditions. The focus is on ensuring that products meet the required quality standards and are safe for consumption.
In a GMP testing laboratory, particular care is taken to ensure that all aspects of the production process are documented and monitored to ensure consistent quality. This includes validating processes, ensuring the correct handling of materials and training of the staff. The laboratory must follow strict regulations and guidelines to ensure that all tests and inspections are accurate and that manufacturing conditions are constantly monitored.
Compliance with GMP guidelines is verified through regular inspections and audits by national and international regulatory authorities. These audits ensure that the laboratory is meeting and continuously improving all required standards. For companies that manufacture their products according to GMP, a GMP testing laboratory provides the necessary quality assurance to ensure that their products are safe, effective and meet regulatory requirements.
An accredited testing laboratory offers many advantages that are of great benefit to both companies and individuals. A key benefit is the high quality and reliability of results. Accredited laboratories must meet strict quality standards, which are regularly checked by independent accreditation bodies. This ensures accurate and reliable analysis, which is essential to meet regulatory and quality standards.
In addition, accredited testing laboratories meet the legal requirements imposed in many industries. By being certified to international standards such as ISO/IEC 17025, an accredited laboratory provides legal certainty and ensures that tests and analyses meet the required standards. This is particularly important for companies in the food, pharmaceutical and environmental sectors.
Accreditation of a testing laboratory also creates trust and recognition with authorities, customers and partners worldwide. The results and services of an accredited laboratory are widely accepted, which strengthens credibility and acceptance among customers and regulatory authorities. Companies can use the results of these laboratories in their reports and documentation, enhancing their position and confidence in their products and services.
Another benefit of an accredited testing laboratory is access to the latest technology and advanced testing methods. To meet the high demands, these laboratories invest in the best available technology, which enables more accurate and comprehensive analysis. This in turn leads to better decisions and actions based on the test results.
Overall, accredited testing laboratories offer a combination of high quality, legal certainty, widespread recognition and advanced technology, making them an essential partner for companies and individuals requiring accurate and reliable testing.
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