Accreditations and Certifications
The reliability, accuracy and full independence of the companies and laboratories have been confirmed by International accreditation bodies in accordance to the following standards and requirements:
In 2016, the J.S. Hamilton Poland laboratory had passed the inspection of the Chief Pharmaceutical Inspectorate, the effect of which the laboratory received an authorisation for the manufacturing, processing and reprocessing psychotropic substances and drugs and the license enabling entry into possession or placing on the market the narcotic precursors of category 1. These approvals allow us to perform analysis and conduct research of medicinal products as well as starting materials under special supervision.
The laboratory J.S. Hamilton Poland received authorisation from Chief Pharmaceutical Inspectorate for manufacturing medicinal products in scope of chemical and physical tests in 2006. The authorisation confirms, that our competences, as well as scientific and research potential, are in line with requirements for external quality control laboratories providing analytical services for pharmaceutical industry.
The first accreditation was granted to laboratory in 1996 by the Polish Centre for Testing and Certification in the scope of food, fuel and fertilizers testing. That accreditation confirmed that technical competence and management system fulfilled requirements of quality assurance system. It was later replaced by PN-EN-ISO/IEC 17025:2018-02 Standard and Certificate issued by Polish Centre of Accreditation (PCA). In 1998 - 2005 laboratory was also accredited by Comité Français d'Accréditation COFRAC to French standards, firstly to ISO/IEC 25, PN-EN 45001 standard and 1002 COFRAC document and later to NF EN ISO/IEC 17025 standard. That accreditation ceased after Poland joined EU in 2005 when PCA accreditation had been recognized internationally. Scope of accreditation, List’s of testing carried out in the framework of accreditation scope
In March 2019, J.S. Hamilton Poland Laboratory met the requirements and conditions to perform laboratory tests related to ensuring feed safety in accordance with the guidelines GMP+ B11 and GMP+ BA 11. Our Laboratory was positively evaluated and approved by GMP+, it was also entered into the database of approved laboratories (registration number: GMP 050186). The scope of registration includes: aflatoxin B1, dioxins, PCBs, heavy metals, fluorine and pesticides.
In July 2016 the laboratory J.S. Hamilton Poland was audited by US FOOD AND DRUG ADMINISTRATION (USFDA), in the area of medicinal products and starting materials tests. In effect of the audit, the laboratory received a positive evaluation from FDA, the institution considered as one of the most demanding, prestigious and opinion-forming in the pharmaceutical industry. We expect to receive USFDA formal authorisation in the nearest future (FDA form 483). It will confirm our highest competences and be a guarantee, that J.S. Hamilton Poland laboratory meets requirements of GMP.
J.S. Hamilton Baltic microbiological laboratory is accredited by the Latvian National Accreditation Bureau (LATAK). The laboratory is competent to carry out the analysis in accordance with the standard LVS EN ISO/IEC 17025:2017 requirements. The identification number of the laboratory LATAK-T-544 The laboratory obtained an accreditation certificate in December 2015 for microbiological analysis of water, foodstuffs and animal feeding stuffs. Then in 2016 year, the accreditation scope was expanded to cosmetics microbiological tests. Scope of accreditation
Our microbiological Laboratory of J.S. Hamilton Hungaria received the accredited status by the National Accreditation Authority (NAH) on the 16th of November 2016 under the registration number NAH-1-1801/2016 and was registered until 15th November, 2021. The National Food Chain Safety Office has licensed the operation of the Microbiological Laboratory on the 27th June, 2016 under the registration number 131/2016/Lab/NÉBIH. Scope of accreditation
First Hamilton’s microbiological laboratory in Romania has received sanitary – veterinary authorization and for safety of food in December 2014. Laboratory profile includes testing of products with animal origin, non-animal, animal feed and water. Reliability, precision and full independence of laboratory has been confirmed by Accreditation Association – RENAR recognized as National Body Accreditation by OG/2009. Accreditation certificate no LI 1081 that has been granted in 23.12.2015 confirms laboratory competence in conformity with requirements of SR EN ISO/IEC 17025:2005 standard. Scope of accreditation
Laboratory J.S. HAMILTON CROATIA (formerly LABOSANO) got the first accreditation certificate in September 2013. After a succesful merger with HAMILTON Group, the acreditation has been transferred to the new company name J.S. HAMILTON CROATIA. The laboratory provides microbiological and chemical analysis of food, animal feed, water and environmental samples as well as cosmetcs. Laboratory J.S. HAMILTON CROATIA is formally approved laboratory laboratory for food analyses by Croatian Veterinry Authorities. Scope of accreditation (enter Hamilton in the search engine)
In March 2005 J.S. Hamilton Poland Sp. z o.o. was accredited by Polish Accreditation Centre (PCA) as Type A (Third Party) Independent Inspection Body according to international standard EN ISO/IEC 17020:2004 (former EN 45004). Accredited activity is defined in the Scope of Accreditation No. AK 011 - details may be found on official site of PCA: www.pca.gov.pl. The achieved accreditations confirm full independence and integrity of J.S. Hamilton Poland as of third party inspection company, working to the highest standards in the industry. Scope of accreditation
The laboratory of J.S. Hamilton Poland as professional supplier of analytical services to pharmaceutical industry has all required certificates and approvals, among others GMP certificates issued by Chief Pharmaceutical Inspectorate. The certificates confirm implementation and observance of Good Manufacturing Practice (GMP) guidelines. The GMP certificates prove that, that laboratory management system is compliant with GMP conditions.