At Medicert, we offer comprehensive Drug Testing services to ensure that medicines meet quality, safety and efficacy standards. With our advanced laboratories and team of experts, we provide high standards of quality control services from the production of pharmaceutical products to market launch.
The Importance of Drug Testing
Pharmaceuticals are critical products that have a direct impact on human health. Compliance with international standards in production and quality control processes is essential to ensure both compliance with legal regulations and the safety of patients. Medicert performs rigorous testing to verify the safety, efficacy and compliance with regulatory requirements. These tests are crucial for the market success of the medicine and patient safety.
Tests Performed within the Scope of Drug Testing
- Chemical Analysis
These tests, which determine the correct proportions and purity of the drug’s components, guarantee that pharmaceutical products are safe and effective. Chemical analysis assesses the accuracy of the active ingredients and the risk of contamination. - Microbiological Tests
Measures the safety of medicines with respect to microbial contamination. Microbiological testing is performed to ensure that medicines meet sterility and microbiological safety standards. These tests are critical for both sterile and non-sterile products. - Stability Tests
These tests determine the stability and shelf life of products in different environmental conditions, ensuring that the medicine remains effective and safe. Conducted in accordance with international guidelines such as CPMP/QWP/122/02 and ICH Q5C, these tests assess the long-term durability of biological and biotechnological products.
– CPMP/QWP/122/02 Stability Test: This guideline defines mandatory requirements for stability testing of existing active ingredients and related finished products. It tests how medicinal products behave under various conditions (e.g. changes in temperature and humidity) and uses this data to determine the shelf life of the medicinal product.
– ICH Q5C Stability Testing (Biotechnological/Biological Products): Stability testing of biotechnological and biological products assesses whether the products maintain their structural integrity and efficacy. The ICH Q5C standard analyzes the stability of these products under different storage conditions. Biotechnological drugs are subjected to special stability tests due to the sensitivity of their production processes. - Solubility Tests
It measures how long it takes for the drug to dissolve in the body and release its active substance. Solubility tests are important to assess the bioavailability of the drug and to confirm its pharmacokinetic properties. - Pharmacokinetic and Pharmacodynamic Tests
These are tests that examine the movement of the drug in the body (absorption, distribution, metabolism, excretion) and its biological effect. These analyses help to optimize dosage and treatment processes by revealing the pharmacological profile of the drug.
Methods and Standards Used in Drug Testing
Medicert performs drug testing in accordance with the standards set by international authorities:
- USP (United States Pharmacopeia) ve EP (European Pharmacopoeia): These guidelines set the quality standards for pharmaceutical products and are the basis for the validity and reliability of test methods.
- JP (Japanese Pharmacopeia): Pharmaceutical standards applicable in Japan ensure that products are recognized in the international market.
- ISO Standards: Quality management systems, especially ISO 13485, ensure control and traceability of production processes.
Guidance on Allergenic Products (EMEA/CHMP/BWP/304831/2007)
This guideline sets out the requirements for the production and quality control of allergenic products. Allergenic products are specialized products that affect the immune system and high safety standards must be applied in the production process. Medicert evaluates biological activity and potential contamination when analyzing these products.
Production and Quality Issues: Strict controls are applied in the production of allergenic products to minimize the risk of cross-contamination. Quality issues are investigated through detailed testing to determine how the product may affect biological activity or the immune system.
Analysis and Interpretation of Results
Medicert provides detailed reports on the results of drug testing. These reports demonstrate that products comply with national and international quality and safety standards and provide quality assurance to manufacturers. The findings in the report guide the development of product formulations and accelerate regulatory approval processes.
Why Work with Medicert?
- Scientific Excellence: Medicert works with the latest technologies and validated protocols to deliver accurate and reliable results.
- Fast and Reliable Service: Our high-capacity laboratory infrastructure ensures fast results and helps you get your products to market as soon as possible.
- International Compliance: Medicert performs testing in compliance with international regulatory requirements, ensuring your medicines are accepted in the global market.