Quality Manufacturing

Rigorous Standards

 

Competitive advantage and reaching/catching up with global models of brilliance are our essential traits for success seeded in our DNA since founding of the company in 2000. By becoming the first GMP certified manufacturing facility in Bulgaria, our plant in Varna set the standard for the industry throughout the whole region.

 

As a long-lasting partner of many multinational businesses such as F. Hoffmann– La Roche AG, Pfizer Inc, Sanofi~Aventis SA, Eli Lilly and Company Inc, AstraZeneca plc, we are often inspected by third parties, ensuring the highest requirements in the industry are met.

 

Tchaikapharma’s pedantic pharmacovigilance is perfectly aligned with the best available techniques in the industry. We apply Standard Operation Procedures which cover detailed presentation of all manufacturing norms and analytical procedures, including working instructions.

 

Quality Control

 

The difficulties in quality control arise from the specificity of the modern manufacturing process – the enormous scale of a million-unit production makes it impossible to inspect the quality of each unit separately. In other words, we have to guarantee statistical reliability between quality assessment results obtained from dozens of tablets and the remaining millions of units, including al batches of a specific drug. In addition, these exact results must comply with preliminarily approved product specifications by the monitoring agency. In order to solve this complex problem, we created a quality assurance system that ensures perseverance of standard manufacturing conditions.

 

Briefly, through a standard manufacturing process using standard raw materials under standard conditions, we obtain a final product with standard parameters – consistent high quality.

 

Quality Assurance System

 

We are convinced that quality assurance represents a mentality and a systematic care for the patients and for common healthcare. A mentality that puts monitoring onto pedestal and assesses all possible risks during the process. From the smallest problems in supply chain, for instance, to possible power outages and the effect of fatigue onto the operator leading to deviations from the specifications.

 

This monitoring and assessment system includes documentation and subsequent review or analysis even if no problem has occurred. All instructions are recorded and confirmed in Standard Operation Procedures (SOP). Each activity is registered by the operator and inspected by the relevant supervisor. In case the activity is not registered, it is considered not carried out.
Recording of each action identifies the operator and enables quick and precise troubleshooting of a problem upon occurrence.

 

An example of such record is the Batch Dossier. This is a collective document that contains all necessary information regarding batch production of a particular medicine. It contains accurate information about the person, time and conditions upon commissioning production, the raw materials used (including related tests), tests carried out on the intermediate and final product, types of labels used for product identification throughout the process, previously manufactured product, means of room and equipment cleaning, yield calculations, quantity of waste disposal, any deviations or cessation of production and in such cases – the level of risk for quality, individual responsible for the risk assessment, etc.

 

Serialization

 

Successful integration of the contemporary serialization and tracking system leads Tchaikapharma to an excellence award in the “Solutions Provider” field at the Pharm Connect congress in 2018 – an event that unites leading pharmaceutical and biotechnology companies from Central and Eastern Europe and the CIS.

 

The serialization process and its integration into the general verification system has been introduced in Europe in order to prevent drugs falsification and provide traceability of each package from its manufacture to end user. According to the World Health Organization (WHO), falsified medicines in developed countries reach 100 million packages per annum, whilst in the remaining countries they account for around 30% of total medicines. The risk is highest through online purchase of drugs, where according to data from WHO the probability of receiving a falsified drug is 50%.