After Market Inspection

 

General

A Risk Management Plan has been created to plan risk management activities in accordance with the relevant standards. The purpose of this plan is to ensure that the Medical Products manufactured by BÖLÜKBAŞI PHARMACEUTICALS  It aims to start the manufacturing process and to identify possible risks, to start working to rank risk criteria, to take measures and to follow up the measures and products.

In addition to the revisions made within the scope of routine improvements, this plan is revised in cases such as changes in personnel in the risk management team, changes in product production process stages, changes in equipment machine components, infrastructure changes, supplier changes.

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Scope of the Risk Management System

The purpose of this plan is to determine the risks that may occur in the production process, to evaluate, reduce and identify the high risks that may cause the loss of potential customers exposed during its use by the end user. This plan is followed by evaluating the risk activity throughout the shelf life of the product, taking into account the continuity of risk throughout the shelf life of the product. 5x5 risk matrix was used for risk analysis. Probability and severity levels are based on EN 14971:2013 Standard requirements.

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