Pharmaceutical quality control
The Quality Control department of the PC Pharmaceuticals comprises coordinated activities for quality control of all the entered and raw materials, thru the manufacturing process until the production of final product with specified shelf life in appropriate storage conditions and specification compliant to the strictest 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 pharmaceutical ingredients, the other compounds and the contact packaging includes activities for control of their physical and chemical properties and microbiological characteristics in accordance with the European and internationally recognized standards. The secondary packaging should provide sufficient and understandable information to the medical personnel and patients. These activities are performed using modern validated instruments and techniques such as: infrared spectroscopy with narrow identification area for each container of incoming raw-material, infrared spectroscopy, total organic carbon analyzers that analyze the total organic carbon in the water as a medium for pharmaceutical production, gas chromatography and high performance liquid chromatography, automatic titration measuring devices, etc.
Control of the phase production and control of final products
The products are monitored in all the phases of their manufacturing, with all their specifics by phase, until the final product is delivered which, from the aspect of physical, chemical and pharmaceutically-technological properties, corresponds to the specifications set forth by the strictest international regulations.
The activities are performed by employing modern validated instruments such as: high performance liquid chromatographs, spectrophotometers connected in line to dissolution equipment and etc.
The analytical methods used for the analysis are continuously upgraded and modernized and accordingly validated resulting in highest level of safety and confidence of their performances.
This controlling part operates within the new microbiological laboratory constructed in compliance with the most sophisticated cGMP norms.
In the microbiologically classified areas appropriate equipment has been installed such as: bio-safety laminar cabinets for analysis performance, incubators, dry sterilizers, autoclaves, coolers/freezers, microscopes, Vitek II instrument for microorganism's identification etc. The following activities are carried out by applying coordinated and strictly determined procedures: control of the products and systems, control of purified water and other media for pharmaceutical manufacturing, supervision of the premises and equipment hygiene in the manufacturing facilities as well as all other activities in compliance with the DPP standards.
As part of the biological tests, the tests for absence of bacterial endotoxins are performed by modern kinetic turbidimetric methods onto the entry raw materials and the finished product that are specific for sterile production.
Stability of the pharmaceutical finished products
Samples from the commercially produced batches are stored in special stability rooms in conditions that simulate the worst case of outdoor conditions at which the products are exposed during their lifecycle until the declared expiry date. In determined plans, reanalysis are performed by which the declared expiry date and the specified storage conditions of the products are proven to be in accordance to the previously defined specification.
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, cleaning validation of the premises and equipment, validation of the water systems for pharmaceutical application, compressed air, steam, cleanness of the equipment etc. With previously defined scheme of critical points in previously defined time frames the routine monitoring of all defined activities is continuously performed.
The quality inputs of raw materials for manufacturing together with the other controlled conditions for pharmaceutical production are preconditions for providing of safe and high quality final product.
The Quality Control department works on development of the analytical part of the documentation required for the registration files of the products, which are integral part of the internationally recognized CTD registration format for pharmaceutical products.