Image

MANUFACTURING PLANTMEDICINAL PRODUCTS

In our branch in Radomsko, as part of the manufacturing process we offer the following services: storage, distribution, labelling, packing and repacking, including batch release after manufacturing processes by a qualified person (QP), of medicinal products, medical devices, dietary supplements and cosmetics for our contractors who are obliged to comply with the requirements of the GMP. Moreover, our offer includes the service of storage and distribution of investigational medicinal products, provided at the request of pharmaceutical companies conducting clinical trials as well as CRO companies.
 

WAREHOUSING AND DISTRIBUTION

We have qualified warehouses and packing facilities that meet the requirements of GMP and GDP. They are equipped with fully modernised technical infrastructure which ensures the proper conduct of manufacturing and storage processes for the goods as well as control of storage conditions. Our facility has two temperature zones, which enable safe storage and repacking of products in ranges: 2 to 8°C (cold stores) and 15 to 25°C (air-conditioned zones). These conditions are controlled by a validated temperature and humidity monitoring system.

The manufacturing process itself is supported by a dedicated validated computer system and is carried out based on procedures and instructions. It includes the following scope:

  • Packing and repacking of medicinal products, medical devices, dietary supplements and cosmetics (2-8°C zone and room temperature zone).
  • At the request of importers and manufacturers, we provide services related to repair activities, replacement of leaflets and cardboard boxes, changing the language version, making series and expiry date printing, as well as product labelling.
  • Preparing marketing samples. We are able to handle this process entirely, starting with product labelling, through notification and shipping to end users, to monitoring the distribution process.
  • Packing of promotional sets according to customer specifications.
  • Shrink wrapping of sets consisting of different products.
  • Handling the printing of packaging materials according to customer specifications (cardboard box, leaflet, label).
  • Sealing packages using labels or hot glue.
  • Storing archival samples.
  • Distributing products for clinical trials. We provide full logistical support for the process including acceptance of comparative and accompanying products, manufacturing activities (label printing and labelling, randomisation), completion of samples for shipment together with documentation, distribution to clinical trial sites, return management with disposal of returns.
  • Releasing series of products after the manufacturing process (certification of the manufacturing stage) by a Qualified Person.

The above scope of activity is conducted in the Importer's Warehouse and CF CEFARM S.A. Medicinal Products Manufacturing Plant in Radomsko on the basis of an authorisation issued by the Chief Pharmaceutical Inspector (Authorisation 054/0299/15). The MIiWPL holds Certificate IWZJ.405.87.2018.ER.1 WTC/0299_03_01/166 – Medicinal products for human use, IWZJ.405.87.2018.ER.2 WTC/0299_03_01/167 – Investigational medicinal products.

Maintenance of the quality assurance system is based on having adequate resources, including personnel with the required qualifications, as well as procedures, to ensure the repeatability of operations relevant to the required quality of products and services.

Favourable location near the E8 national route allows convenient access and efficient distribution throughout the country.