NIKA PHARM has an integrated management system, which is a set of implemented ISO standards and good GxP practices.

The main role in minimizing the risk of defects in the production of medicines is assigned to the production personnel and the Quality Assurance and Quality Control departments, which develop and monitor the implementation of prescribed procedures, analyze the results and work to improve processes. And pharmacovigilance, in turn, is focused on post-marketing surveillance and focuses on the risks that are possible when using medicines (adverse reactions, insufficient effectiveness).

Pharmacovigilance: protecting patients and the company's reputation

Pharmacovigilance (PV) at NIKA PHARM is a system of control, analysis and prevention of risks associated with the safety and effectiveness of drugs.

The task of pharmacovigilance is to prevent, identify and minimize the risks associated with possible side effects. Everyone knows that any drug can cause an adverse reaction or hypersensitivity reaction when used.

In this regard, the employees of the Pharmacovigilance Department:

- promptly respond to incoming complaints and reports of side effects;

- analyze each report and, if necessary, forward the information to the authorized bodies;

- monitor reports of adverse reactions to drugs in accordance with the requirements of regulators;

- develop and implement measures to improve the safety of drugs.

This activity is aimed at monitoring the frequency of adverse reactions, as well as identifying their cause-and-effect relationship.

Continuous monitoring and risk minimization

Daily monitoring of reports of adverse reactions to drugs for all existing regulatory authorities is a mandatory and integral part of the Pharmacovigilance Department.

Thus, pharmacovigilance activities include measures to monitor the safety of drugs, timely detection of all changes in the benefit-risk ratio of drugs, development and implementation of measures to ensure the use of drugs when the benefit exceeds the risk.

These measures include:
- updating information in the instructions for medical use;

- informing the medical community and consumers about the correct use of drugs;

- conducting training events for medical workers and partners.

Product recall: standardized response procedure

In the event of a defect or the need to recall a drug from circulation, the company acts in strict accordance with the standard operating procedure (SOP).

As part of the SOP, an assessment is made of the effectiveness of risk minimization throughout the entire life cycle of the drug.

In the event of a complaint, an authorized person conducts an investigation and decides on the necessary measures.

If risk minimization proves ineffective, the drug may be recalled from the market or its use may be restricted.

Conclusion

Pharmacovigilance at the production site of NIKA PHARM complies with the requirements of standards and regulations, prevents problems, minimizing the risks of defects, drug recalls and adverse effects for patients.

Thus, pharmacovigilance at the production site plays an important role in ensuring the safety and effectiveness of medicines