MEDICINAL PRODUCTS

As part of contract manufacturing, Medicofarma S.A. offers comprehensive services regarding introduction of medicinal products to the market. We develop formulations and deliver product packaging adapted to our clients’ individual requirements. For prescription medication, we also offer product serialization. We offer a comprehensive range of services allowing effective implementation of contract manufacturing of pharmaceuticals. To guarantee a smooth course of the manufacturing effort, we will gladly provide advice and assistance at every stage of product development. Drawing on the experience of our experts and the potential of our technical facilities, we are able to guarantee success of each project.

We develop formulations and manufacturing technology for pharmaceutical products. Depending on the customer’s requirements, we are able to adapt an existing formulation to market requirements or develop a new, original formulation. We draw on the experience of our experts, who approach each entrusted project with a high degree of precision. Therefore, the characteristics of the end product are 100% in line with the preliminary assumptions.

The process of formulation development requires a meticulous selection of constituents, the amounts and sequencing. All these factors determine the form of the product and condition its effectiveness. Developing the formulation from micro to macro scale, we pay particular attention to ensure product stability and safety.

Correctly drawn up documentation is necessary for introducing a valuable and useful product into circulation. Therefore, our customers receive full technical documentation containing the entirety of information required by the current directives and ordinances. This also applies to the description of the action of the final product, technical details and manufacturing procedures confirming that it meets the applicable requirements.

We perform simulations of the manufacturing process in a laboratory environment. As a manufacturer of pharmaceuticals, medicinal products, dietary supplements, we carry out modeling of the manufacturing process to verify if the provided materials meet all the applicable requirements and have the characteristics as provided in the specification. The trials use identical devices and equipment as the actual manufacturing to demonstrate accuracy and repeatability of the process.

We prioritize the needs of our customers, therefore it is possible to adapt the scale of the manufacturing process to the submitted specification. We possess the necessary facilities to handle production in large and very large series. At the same time, it is possible to manufacture small series of products at optimal cost.

We carry out the adaptation process for study results and analytical methods to enable their practical application in manufacturing medicinal products. We also provide services to our customers to develop analytical methods allowing to identify a specific component in the sample. This procedure involves all the process stages – from sample collection to obtaining and processing the results.

We carry out analytical examinations of medicinal products. The purpose is quality control and verification of compliance with the specification of the given product. All the examinations are carried out based on our QM system meeting the principles of GMP (Good Manufacturing Practices). Modern technological facilities allow us to utilize various analytical methods.

We monitor and supervise the implemented analytical methods through regular verification of their conformity with the results expected. Specifically, the following characteristics are subject to verification: accuracy, precision and reproducibility of the analytical method. Method revalidation is also carried out in accordance to the requirements – in particular during equipment changeover or change of personnel.

Carrying out medical substance identification using FTIR (Fourier Transform Infrared Spectroscopy). This method features higher speed and accuracy, its implementation is possible through the use of a modern Fourier-Transform spectrometer.

Our services include release testing of pharmaceuticals. This examination enables to determine the amount of medicinal substance released from the pharmaceutical product as well as the speed of this process. We also determine release profiles for solid form of medicinal products. It is a tool for controlling product quality. It helps with the evaluation of expected product behavior in natural conditions, enabling to determine material similarities between the examined product and products approved for circulation.

We carry out the full procedure of release for circulation with prior testing, inspections, controls as well as preparing the necessary documentation. These activities are to demonstrate that the product quality is satisfactory and meets the principles of Good Manufacturing Practice.

As part of contract manufacturing of medicinal products we also carry out studies of raw materials and finished products. We also carry out analytical determination works in order to verify identity of material, content and purity analysis (determination of impurities, e.g. heavy metals and leftover solvent residuals). The analytical determination is also used to identify substances such as coloring, preservatives, anti-oxidants. The Karl-Fisher method is used to determine water content in the substance together with loss of mass after drying.

• analytical examinations of active substance release profile
• examination of disintegration time
• examination of physical characteristics (including bending strength of tablets, density, viscosity, etc.)
• On request, we are also able to carry out additional examinations. To this end, we require exact specification of the customer’s requirements together with making arrangements for the scope of works.