Pharmaceutical quality control
The quality control segment of the PC Pharmaceuticals comprises coordinated activities for quality control of all the material entered, the manufacturing process until the final product phase, with specified shelf life in appropriate storage conditions and specification compliant to the most strict European and international standards. The quality control is consisted of several coordinated activities.
Control of the raw materials, contact and secondary packaging
The control of the active ingredients, other compounds, the contact packaging include activities for controlling their physical and chemical properties in accordance with the European and internationally recognized standards. These activities are carried out with modern validation instruments such as: infrared spectroscopy with narrow identification area for each container of incoming raw-material, infrared spectroscopy, analysis of the total organic carbon in the water as a medium for pharmaceutical production, gas chromatography, automatic titration measuring devices, etc.
Control of the phased production and control of final products
These products are monitored in all the phases of their manufacturing, with all specifics until the final product is delivered which, from the aspect of physical, chemical and pharmaceutical technological properties correspond to the specifications set forth by the strictest international regulations.
The monitoring of stability is carried out during the declared shelf life. All activities are carried out with modern validation instruments such as: liquid chromatography under high pressure, spectrum-photometric instruments connected in a line with dissolving devices, etc.
Microbiological control
This controlling part functions within the new microbiological laboratory constructed in compliance with the most sophisticated cGMP norms.
Appropriate equipment has been installed in classified areas such as: bio-safety cabinets, incubators, dry sterilizers, autoclaves, freezers, microscopes, vitek instrument for microorganism's identification etc. The following activities are carried out by applying coordinated and strictly determined procedures: control of the product, of systems, media for pharmaceutical manufacturing, of the supervision of the premises hygiene and equipment as well as all other activities in compliance with the DPP standards.
As part of the biological tests, subject to monitoring are the bacteria endotoxines into the entry materials, the contact packaging, the phase production and the finished product, that are specific for sterile production.
Validation activities and monitoring
In the frames of the GMP operations, the following analysis are implemented related to: validation of the analytical methods, validation of the production processes, validation of the premises hygiene and equipment, validation of the water systems for pharmaceutical application, compressed air, steam, cleanness of the devices, etc. The quality input for manufacturing together with the other controlled conditions for pharmaceutical production are preconditions for providing of safe and high quality final product.
Analytical development of new products and stability
All new products of Alkaloid-Pharmaceuticals are controlled in the Laboratories for quality control, by means of highly developed analytical methods, validation methods, comparison studies with parallel products, stability studies, etc.
Registration activities
The quality control segment works on development of the analytical part of the documentation required for the registration files which are integral part of the CTD registration format.