Ensuring Quality and Safety

Commitment to Quality
Our high quality products not only meet Bulgarian regulatory requirements and international standards, but surpass them. We are committed to pursuing quality and innovation and exceeding expectations.

Rigorous Standards
High quality benchmarks have been the core of our corporate philosophy since our inception in 2000. Our first manufacturing site in Varna was the first GMP compliant manufacturing facility in Bulgaria to set the standard for the industry throughout the region.

As a long-term partner of many multinationals such as F. Hoffmann-La Roche AG, Pfizer Inc, sanofi~aventis SA, Eli Lilly and Company Inc, AstraZeneca plc, we are frequently inspected for compliance with the highest industry requirements.

Tchaikapharma’s own pharmacovigilance is aligned with the best-in-industry practices. Our quality control and assurance departments report directly to our CEO. We use Standard Operating Procedures, which provide all the necessary detailed descriptions of manufacturing and analytical procedures, as well as working instructions.

Quality Assurance
The difficulties in quality control in today’s manufacturing arise from the specificity of the manufacturing process: on the one hand it is a large scale process – millions of product units are manufactured – and on the other hand it is not possible to check the quality of each unit manufactured.

In other words, we have to guarantee that the quality control results obtained from tens of tablets are statistically reliable for all the millions of tablets in one batch, as well as for all batches of a particular drug. In addition, we need to make sure these results comply with the specification for this product as approved in advance by the controlling agency. To solve this equation with many unknowns, we created a quality assurance system which enables the maintenance of standard manufacturing conditions.

How we maintain quality
To put it simply, in a standard manufacturing process with standard starting materials, we obtain a finished product with standard parameters, which guarantees quality.

Quality as a way of thinking
We are convinced that quality assurance is a way of thinking – a systematic care for patients and public health. A way of thinking, which extols supervision and evaluates all possible process risks – from the smallest problems in supplies, for example, to the possible power supply failures and the effect of a tired operator on the specification deviation. This supervision and evaluation system involves documenting everything as well as performing further review and analysis even in the cases when no problem has occurred.

An inside glimpse: our quality-assurance process
All instructions are recorded and approved as Standard Operating Procedures. Each activity has to be recorded by an operator and inspected by the relevant supervisor. The recording of each action identifies the operator and enables a fast and thorough troubleshooting, when needed.

Meticulous recording
A Batch Record is a shared document in which all the information about the manufacturing of each batch is recorded. It contains information about the person, time, and conditions of the manufacturing process inception, the starting materials (with the relevant tests), the tests performed to the intermediate and finished product, the labels the product has been identified with during the manufacturing process, what was manufactured before that and how the room and the equipment was cleaned, how the output was calculated, how many rejects have been separated, whether there were deviations or down time, what was their quality related risk, who evaluated them and more. This batch record is stored for one year after the shelf life expiry date of the pharmaceuticals from the relevant batch and contains its written history. The quality assurance system allows not only to analyze a particular problem, but also to plan actions to prevent its possible reoccurrence.

Training
Training is also related to the quality assurance system. We have introductory, regular and specialized training, ending with examinations and their respective results.

Investing in quality
Maintaining a quality assurance system involves additional qualified personnel and increases non-manufacturing costs. In general it has a negative effect on the company’s financial results, especially in a market where many of the popular medicines cost less than a pack of cigarettes. Despite that, we are committed to high quality manufacturing and guidance in the system of quality control. We will continue to develop it in the future, knowing that our real value lays in the excellent treatment, the years of good health and the relief we bring to the consumer.

Manufacturing effective and safe medicines
Fully aware of our responsibility to protect the health of our employees, we take all necessary, mandatory and supplementary measures to minimize the possibility of harmful impact of the active substances on the employees.

Some of these measures are:

• Special dust protection masks and gloves to protect the manufacturing and laboratory staff from the impact of the pharmaceutical substances; uniforms which minimize pharmaceutical dust contact with the employee’s skin. Moreover, clothes are changed after completion of each batch;
• The work with pharmaceuticals is performed in the so called clean areas, where the rate of air exchange is 20 times per hour, which does not allow for the accumulation of pharmaceutical dust in the room
• To limit the potential exposure to harmful impact, the employees in the highest risk zones switch every four hours;
• Employees attend annual check-ups.

The zones with non-packaged medicines and active substances are designed and implemented in a way that ensures that the dust pollution remains “closed” therein. In this way the safety of the employees who don’t work with pharmaceuticals is guaranteed. This is implemented with specially designed ventilation systems with areas of lower and higher air pressure and filtration. Upon leaving the zone, employees change their attire.

Employees are instructed on how to work with and handle risky substances, and what measures to take in case of direct contact with the skin, mucous membranes and eyes. In order for the personnel to cope adequately and to comply with the procedures for work with pharmaceuticals and active substances, we hold a specialized selection, training and control that comply with the highest requirements of the Good Manufacturing Practice (GMP) standard.