Pharmaceutical Product

GLP Studies for Pharmaceutical Product

Good Laboratory Practice (GLP) was originally established by the FDA to assess the safety of pharmaceutical laboratory studies, including in vitro and in vivo testing systems. The main objective is to protect the integrity of the scientific data of the study by providing a verifiable record of the open-ended research studies required to produce the product.

Testing of pharmaceutical products involves long-term testing to obtain traceable data necessary for verification of product suitability and market introduction. These are critical testing procedures during the market entry phase of pharmaceutical products.

Physicochemical Tests

Physicochemical tests, which are applied to ensure the quality and safety of pharmaceutical products, are intended to comprehensively evaluate the chemical and physical properties of drugs.

• Identification Tests: Spectroscopic, chromatographic and chemical reaction-based methods are used to confirm the identity of an active substance or pharmaceutical formulation. These tests are defined in official sources such as the European Pharmacopoeia (Ph. Eur.) and the US Pharmacopoeia (USP).
• Purity Tests: Limit tests or quantitative analyses are performed to identify possible impurities (e.g. residual solvents, reagent residues or degradation products) that may be present in the drug composition.
• Water Content Determination: The amount of water present in pharmaceutical raw materials or formulations is usually measured by sensitive analysis methods such as Karl Fischer titration.
• Sterility Test: Performed to check for the presence of microorganisms in preparations that must be sterile, such as injectables and eye drops.
• Bacterial Endotoxin Test: It is applied to detect and quantify pyrogenic substances or bacterial endotoxins that may be present in parenteral products or medical devices.

In Vivo Tests

In vivo studies conducted to support drug safety and efficacy demonstrate the effects of the test substance on living organisms.

• Safety Pharmacology Studies: The adverse effects of drug candidates on vital physiological systems such as the cardiovascular system, respiratory system and central nervous system are studied in accordance with ICH S7A and S7B guidelines.
• Acute Toxicity Tests: Toxic effects after a single exposure to the test substance are evaluated according to OECD guidelines 420, 423 (oral), 402 (dermal), 403 (inhalation).
• Repeated Dose Toxicity Studies: The effects of doses administered over a period of time such as 28 or 90 days on target organs and dose-response relationships are investigated in accordance with OECD guidelines 407, 408, 410, 409, 411.
• Genotoxicity Tests: These studies, which are conducted to detect possible harmful effects of drugs on DNA, consist of both in vitro and in vivo tests.
  • OECD 474: Micronucleus formation in bone marrow erythrocytes is evaluated.
  • OECD 475: Structural chromosome abnormalities are detected.
    These studies are conducted in accordance with ICH S2 guidelines.
• Reproductive and Developmental Toxicity Tests: Potential harmful effects of the drug on fertility, pregnancy and offspring development are investigated by the following tests
  • OECD 414: Impacts on prenatal development,</li
  • OECD 415: Single generation reproductive assessment,
  • OECD 416: Comprehensive analyses over two generations.
    These studies are in line with ICH S5 guidelines.
• Local Tolerance Tests: The risk of local reactions (e.g. irritation or inflammation at the injection site) at the site of drug administration is assessed.

"Good Laboratory Practices (GLP)" through our solution partners and foreign partners in accordance with the relevant legal regulations and standards in our laboratories serving in many parts of Turkey It is carried out on pharmaceutical products.

You can contact us for "Good Laboratory Practices (GLP)" on pharmaceutical products.