Quality Control
Quality Control Department is an integral part of Profarma and operates independently from all other sectors in the company. The purpose and responsibility of this department is to constantly monitor all products produced by Profarma and to make sure that their quality and efficiency is preserved in compliance with all standards applicable to the pharmaceutical industry.
The Quality Control Department relies on the work and experience of a specialized staff of about 20 professionals in the fields of chemistry, pharmacy and microbiology.
Analytical
Raw material (active and inactive ingredients, immediately packaging) used for the production of pharmaceutical products. All tests are performed using contemporary instruments and techniques in accordance with the required European and International standards.
In process controls and controls of the finished product.
This is achieved by monitoring all intermediate phases of production till the final product for the physical, chemical, microbiological and technical-pharmaceutical properties, according to the requirements and specifications of contemporary pharmacopoeial standards. All these processes are performed by the use of necessary equipments and therefore it is worth mentioning the latest investments for the acquisition of new instruments such as: Stability chamber; HPLC 1100 – with Refractive Index; HPLC-1200; FT-IR spectrophotometer; Pharmaceutical UV-Vis spectrophotometer; Dissolution apparatus; dissolution testers; disintegration testers; hardness testers, etc Stability of Finished Products
For each commercial scale batch, samples are taken and are appropriately stored in special stability rooms in normal conditions, in compliance with the requirements. According to standard stability protocols, each sample is continuously retested.
Microbiology
Microbiological Controls
The Microbiological control operates in a new laboratory, constructed in accordance with the new GMP requirements. It is worth mentioning that the air before entering into the microbiological laboratory passes through the F7 and F9 class filters and then through the 11 HEPA filters.
Environments in this laboratory have been equipped accordingly based on the microbiological classification with the following equipments: laminar flow cabinet for testing, incubator, dry heat sterilizer, autoclave, microscope, etc.
In the microbiological laboratory, the entire activity is conducted according to the required pharmacopoeial procedures:
- microbiological control of the products and periodic monitoring of the production environments according to the requirements and according to the classification of the environments;
- daily bacteriological control of water for injections for the absence of bacterial endotoxin ; periodical controls of the purified water for microbial contamination and periodical control of water for injection for sterility test.
- biological tests include tests on microbial contamination in active and inactive ingredients, in the finished products and sterility tests for each production batch of sterile products;
- the determination of the Antibiotics – Microbial Assay for some active ingredients and finished pharmaceutical products.
