<h3 style="text-align: center;">Medicinal products and starting materials</h3>
At present the rapid development of the pharmaceutical industry forces one to use highly specialized companies providing analytical services meeting requirements of the Pharmaceutical Law.
Therefore, J.S. Hamilton Poland offers you a wide range of tests performed in the well-equipped laboratories having the following accreditations:
<ul style="text-align: justify;">
<li>license for manufacturing medicinal products in the scope of physical and chemical testing issued by Chief Pharmaceutical Inspectorate</li>
<li>license for manufacturing, processing and altering psychotropic substances and drugs</li>
<li>Good Manufacturing Practice (GMP) certificate. A GMP is a system for ensuring that products, both for human and animal use, are consistently produced and controlled according to high quality standards</li>
<li>accreditation of Polish Centre for Accreditation in compliance with PN-EN ISO/IEC 17025 (certificate AB 079)</li>
</ul>
Additionally, in July 2016 J.S. Hamilton Poland has positively been inspected by FDA and received approval without observations documented on Form 483 on pharmaceuticals.
Our company offers research and development services, such as:
<ul style="text-align: justify;">
<li>development of analytical methods using chromatographic, spectroscopic and classical methods. We provide tests within guidelines of International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), European Medicines Agency (EMA) and Food and Drug Administration (FDA)</li>
<li>validation of analytical method &ndash; both developed at J.S. Hamilton Poland Sp.z o.o. and at Client&rsquo;s Lab</li>
<li>transfer of analytical method &ndash; to and from J. S. Hamilton Poland Sp.z o.o. Laboratory</li>
<li>stability studies &ndash; J.S. Hamilton Poland Sp.z o.o. lab is geared with climatic chambers to conduct stability tests which are monitored and controlled for 24h</li>
<li>cleaning validation analysis &ndash; extensive experience allows us to develop and validate analytical methods used to assess the effectiveness of the process of cleaning manufacturing equipment</li>
<li>development and validation of elements labeling method in API and final product with ICP-MS technology in compliance with USP and EP.</li>
</ul>
We also provide quality control services, including:
<ul style="text-align: justify;">
<li>identification of chemical substances</li>
<li>assay</li>
<li>purity testing</li>
<li>residual solvents</li>
<li>element labeling with ICP-OES and ICP-MS methods</li>
<li>dissolution profile</li>
<li>disintegration testing</li>
<li>stability studies</li>
<li>labeling of active traces of residual substances</li>
</ul>
We can boast ourselves of highly experienced scientists and team of experts who specialize in the field of analytical chemistry and microbiology. Well-qualified specialists employed at J.S. Hamilton ensure that the quality of each batch of medicinal product is impeccable. With our state of the art equipment and a team of well trained specialists we ensure the highest level of analytical services.

<h3 style="text-align: center;">Medicinski proizvodi i sirovine</h3>
Nagli razvoj farmaceutske industrije prisiljava proizvođače na kori&scaron;ćenje usluga visokospecijalizovanih kompanija koje nude analitičke usluge u skladu sa važećom regulativom. J.S. Hamilton u Poljskoj nudi &scaron;irok spektar analiza koje se obavljaju u vrhunski opremljenim laboratorijima uz sledeće licence i akreditacije:
<ul style="text-align: justify;">
<li>Licenca za proizvodnju medicinskih proizvoda u okviru fizičkih i hemijskih testiranja, izdata od strane Glavne farmaceutske inspekcije Poljske</li>
<li>Dozvola za proizvodnju, preradu i izmenu psihotropnih supstanci i lekova</li>
<li>Certifikat dobre proizvođačke prakse (GMP). GMP je sistem kojim se osigurava da su proizvodi za ljudsku i životinjsku primenu proizvedeni i kontrolisani u skladu sa visokim standardima kvaliteta</li>
<li>Akreditacija Poljskog akreditacijskog Centra u skladu sa normama PN-EN ISO/IEC 17025 (certificate AB 079)</li>
</ul>
Takođe, u julu 2016. godine J.S. Hamilton u Poljskoj je uspe&scaron;no pro&scaron;ao inspekciju FDA i dobio odobrenje bez primedbi, &scaron;to je dokumentovano u Obrascu 483 o farmaceutskim proizvodima.
Na&scaron;a kompanija sa sedi&scaron;tem u Poljskoj nudi i usluge istraživanja i razvoja, poput:
<ul style="text-align: justify;">
<li>Razvoj analitičkih metoda kori&scaron;ćenjem hromatografskih, spektroskopskih i klasičnih metoda. Nudimo analize prema smernicama Međunarodnog saveta o usklađivanje tehničkih zahteva za prijavu lekova za ljudsku upotrebu (ICH), Evropske agencije za lekove&nbsp; (EME) i Američke agencije za hranu i lekove (FDA)</li>
<li>Validacija analitičkih metoda &ndash; razvijenih u J.S. Hamilton i u laboratoriji klijenta</li>
<li>Prenos analitičkih metoda &ndash; u i iz J.S. Hamilton laboratorija</li>
<li>Studije stabilnosti &ndash; J.S. Hamilton je opremljen klimatskim komorama za izvođenje testova stabilnosti koji se prate i kontroli&scaron;u tokom 24 sata</li>
<li>Analiza provere či&scaron;ćenja &ndash; veliko iskustvo nam dozvoljava da razvijamo i validujemo analitičke metode koje se koriste za procenu efikasnosti postupka či&scaron;ćenja proizvodne opreme</li>
<li>Razvoj i validacija metoda označavanja elemenata u API, i gotovom proizvodu sa ICP-MS tehnologijom, u skladu sa USP i EP.</li>
</ul>
Nudimo i usluge kontrole kvalitete uključujući :
<ul style="text-align: justify;">
<li>Identifikaciju hemijskih supstanci</li>
<li>ispitivanje</li>
<li>testiranje čistoće</li>
<li>ostaci rastvarača</li>
<li>obeležavanje elemenata kori&scaron;ćenjem ICP-OES i ICP-MS metoda</li>
<li>profil rastvaranja</li>
<li>testiranje razgradnje</li>
<li>studije stabilnosti</li>
<li>označavanje aktivnih tragova zaostalih supstanci</li>
</ul>
Ponosimo se na&scaron;im iskusnim naučnicima i timom stručnjaka koji su specijalizovani za područje analitičke hemije i mikrobiologije. Visokokvalifikovani specijalisti iz J.S. Hamiltona osiguravaju da je kvalitet svake serije medicinskog proizvoda besprekoran. Uz na&scaron;u vrhunsku opremu i tim vrhunski obučenih stručnjaka garantujemo najvi&scaron;i nivo analitičkih usluga.

Medicinski proizvodi i sirovine

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