The Quality Control department of the PC Pharmaceuticals has laboratory premises of around 3000 m2.  The QC department employs a large number of highly trained and experienced professionals and over 70 % of them have obtained at least a university degree. The equipment and instrumentation in its state-of-the-art laboratories are controlled via high-end software and complies to all Data Integrity requirements, which enables improved laboratory productivity and increased traceability. All computerized systems and instruments comply to the 21 CFR part 11 and Data Integrity regulations which ensure that the generated data are e-signed and safely stored, backed up and archived throughout its lifecycle.

The Quality Control department comprises coordinated activities for quality control of all the incoming and raw materials, through 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 and processes that are integrated in the Alkaloid’s Integrated Pharmaceutical Quality System, based on the cGMP requirements. Continuous and efficient processing, monitoring and management of all information regarding the processes is done via AlkaSAP system.

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: Near-Infrared and RAMAN Spectroscopy for each container of incoming raw-material, Infrared spectroscopy, TOC analyzers that analyse 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. These instruments and generated data are controlled via software that complies to all applicable current standards and regulations.

Control of the phase production and control of final products

The products are monitored in all the phases of their manufacturing process, with all their specifics by phase, until the final product is delivered. The final products, from the aspect of physical, chemical and pharmaceutically-technological properties aspects, corresponds to the specifications set forth by the strictest international regulations.

The activities are performed by employing modern validated instruments and techniques such as: HPLC and GC chromatographs, spectrometers, dissolution systems etc. There are several software platforms such as CDS – Chromatography Data System that capture and safely store the data, in compliance with all applicable Data integrity guidelines and regulations.

The analytical methods used for the analyses are continuously upgraded and modernized and accordingly validated resulting in highest level of safety and confidence of their performances.

Microbiological control

The microbiological activities are performed in separate laboratory premises constructed in compliance with the most sophisticated cGMP standards. In the microbiologically classified areas appropriate equipment has been installed such as: bio-safety laminar cabinets, incubators, dry sterilizers, autoclaves, coolers/freezers, microscopes, microorganism identification systems 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 incoming 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 climate conditions at which the products are exposed during their lifecycle until the declared expiry date. The conditions in the special stability chambers are being continuously monitored and controlled using a software as an integral part of the stability chambers and also via an additional independent software system for monitoring. By performing stability studies, 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 accordance with   the GMP operations, the following process are implemented in relation to: validation of analytical methods, validation of the production processes, validation of the cleanliness of the premises and the 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 products.

Registration activities

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.

This group consists of pharmaceutical products usually sold in pharmacies without a prescription. They are usually used as food supplements or as support in the prevention and treatment of various health conditions.  

Our aim at Alkaloid is a permanent improvement and maintenance of each individual’s health. We continuously invest in creating high-quality products and are proud they are accessible to everyone in our country.   

Today, we sell more than 70 products in more than 20 markets worldwide. They’re intended for all age groups, from the youngest to the oldest. They belong to various categories, such as symptomatic pain and cold relief drugs, digestive health support products, immunity products, general health improvement, eye health support, and other categories.  

The brands Caffetin, Blokmax, Proculin, Acerola, GastroGuard, Multi Еssence, Bronles, Diastop, Becutan KIDS VITS, Lunerba, and many others are our promise that we remain committed to our motto "Health Above All." 

Check our portfolio of OTC and health products to find out more.