Pharmaceutical Branch

Medicinal products and starting materials

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:

 

  • license for manufacturing medicinal products in the scope of physical and chemical testing issued by Chief Pharmaceutical Inspectorate
  • license for manufacturing, processing and altering psychotropic substances and drugs
  • 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
  • accreditation of Polish Centre for Accreditation in compliance with PN-EN ISO/IEC 17025 (certificate AB 079)

 

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:

  • 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)
  • validation of analytical method – both developed at J.S. Hamilton Poland Sp.z o.o. and at Client’s Lab
  • transfer of analytical method – to and from J. S. Hamilton Poland Sp.z o.o. Laboratory
  • stability studies – 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
  • cleaning validation analysis – extensive experience allows us to develop and validate analytical methods used to assess the effectiveness of the process of cleaning manufacturing equipment
  • development and validation of elements labeling method in API and final product with ICP-MS technology in compliance with USP and EP.

 

We also provide quality control services, including:

  • identification of chemical substances
  • assay
  • purity testing
  • residual solvents
  • element labeling with ICP-OES and ICP-MS methods
  • dissolution profile
  • disintegration testing
  • stability studies
  • labeling of active traces of residual substances

 

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.