Quality Assurance
Remedix care - bringing health to your home
At Remedix Care compounding center, we attribute the utmost importance to conducting all processes in accordance with the most rigorous standards, in the aim of ensuring the .quality of our products
The quality assurance process is carried out in every stage of the process - from receipt .of the prescription through supply of the pharmaceutical preparation to the patient
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Manufacturing at Grade A quality level - in accordance with international standards
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Manufacturing using advanced automatic pumps to ensure high-level precision in aseptic
preparation
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Evaluation of all products and batches prior to release
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Implementation of work methods and inspection in accordance with international regulation
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Work instructions based on USP 797 procedure
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Implementation of internal inspections and investigations, handling complaints, and advancing corrective and preventive action
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Only working with authorized suppliers - in accordance with the relevant regulations in the given business field
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Conduct quality inspections - AUDIT - for all suppliers
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Employee certification using a supervised and comprehensive certification system, valid tests, Media fill*, and internal inspections
Quality assurance processes at Remedix Care
Employee certification using a controlled and comprehensive employee training system, hands-on tests, Media fill and internal checks.
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Certificate of GPP (good preparation practices) in the pharmacy, in accordance with Ministry of Health Procedure 135 and Procedure 132
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ISO 13485:2016 - Marketing and Importation of Medicinal Products; 2. Compounding aseptic pharmaceutical preparation[E1]
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ISO 9001:2015
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Distribution to customer homes and to medical institutions in accordance with the GDP standard, under proper distribution conditions, in accordance with Ministry of Health Procedure 126
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ISO/IEC 17025:2017 - certification indicating the internationally recognized professional competence and operation of the quality management system, issued by the Israel Laboratory Accreditation Authority
Our Quality Certifications
The quality assurance system at Remedix Care compounding center includes a wide range of inspections aimed at ensuring and verifying the safety of the production processes in clean rooms, as well as the quality and validation of the pharmaceutical preparations manufactured in these rooms.
To perform control processes in accordance with local regulations and pharma industry standards, the analytical lab was established - a QC (quality control) lab as an inseparable part of the center for pharmaceutical preparations. This lab, that performs analytical analyses and microbial analyses, is unique in the world of compounding centers.
Our Laboratories
The Analytical laboratory:
The analytical laboratory performs daily analyses in order to evaluate the integrity of the automatic pumps. The qualitative and quantitative analyses of the solution components are performed using an advanced analytical device to validate the integrity of the pumps, and .ensures the precision of the preparations
In accordance with Procedure 135, every compounding center is required to perform microbial monitoring of various contaminants in the clean rooms, and of the individuals working in the clean rooms.
Ongoing monitoring of the fume hoods, daily monitoring of the work team and daily monitoring of the clean rooms. The monitoring process is controlled using designated software for managing the environmental or personal samples. This enables timing, control and tracking of about 200 samples daily from the clean room QC laboratory.
A system of temperature-regulated incubation cells (the incubators), located at the compounding center allows for ongoing monitoring of samples and for the existence of various contaminants.
