Pharmacovigilance Quality System

 

Our pharmacovigilance system is defined as the system used by license holders and applicants, the Agency and other organizations to fulfill the duties and responsibilities specified in the Regulation on the Safety of Medicines, and which is designed to monitor the safety of medicines and detect all possible changes in the benefit/risk balance.

The quality of the pharmacovigilance system is all the features of the system designed, including the estimated probabilities, to achieve results in line with the goals of pharmacovigilance.

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Quality Objectives of the Pharmacovigilance System

 

• To fulfill the duties and responsibilities related to pharmacovigilance in accordance with legal requirements.

• To take the necessary measures to prevent harm to humans caused by adverse reactions arising from the use of drugs or occupational exposure, within or outside the license conditions.

• To ensure the safe and effective use of medicines by providing timely information on the safety of medicines to patients, healthcare professionals and the public.

• To contribute to the protection of patients and public health.

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Pharmacovigilance General Quality Management System

 

Documents to be used within the scope of the pharmacovigilance system are prepared according to the Document Preparation and Data Control Procedure. The records related to the prepared documents are kept in accordance with the Quality Records Control Procedure, which are related to the general quality management system, and the records that only concern pharmacovigilance are kept in accordance with the Pharmacovigilance Data Archiving Instruction.

 

All resources to be used in the pharmacovigilance system are provided by us. There is a Pharmacovigilance Unit in our company to carry out pharmacovigilance procedures. In order to carry out pharmacovigilance activities, participation in Pharmacovigilance Trainings given by TÜFAM is ensured.

All necessary documentation and Master File of the pharmacovigilance system were created and put into practice. The functioning of the pharmacovigilance system is audited through regular internal audits. Findings obtained as a result of audits are evaluated, actions are taken if deemed necessary.

The functioning of the system is evaluated by the management review.

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Adverse report :

contact@bolukbasiilac.com

farmakovijilans@bolukbasiilac.com