GLP Identity Checks for Pharmaceutical Products and Nano Test Solutions

In the pharmaceutical industry, patient safety and product quality are undoubtedly the two most important factors. A medicinal product must be checked before its market launch and at every stage of the manufacturing process. It is precisely at this point that GLP identity tests for pharmaceutical products come into play. Good Laboratory Practice (GLP) is a quality assurance system that ensures these tests are performed reliably, reproducibly and in accordance with international standards.

The "identity" of a pharmaceutical product refers to its molecular structure, chemical formula and physical properties. Using a false raw material or cross-contamination in the production line can lead to irreparable consequences. Therefore, identity checks within the framework of the GLP serve to analytically prove that the product is actually the "desired active ingredient".

The importance of identity checks in pharmaceutical products

Identity checks are not only an analysis, but also a legal obligation. Regulatory authorities such as the FDA, EMA and TİTCK require proof that these audits have been carried out in accordance with the GLP principles in applications for approval and routine quality control processes. Without identity verification, the release (release) of a product is not possible.

The GLP standards set strict rules in areas such as personnel training, device calibration, standard work instructions (SOP) and data integrity. As a result, the results achieved are internationally recognized. These reviews also play a major role in combating counterfeit medicines and ensuring the security of the supply chain.

Basic analytical methods within the framework of the GLP

Several analytical techniques can be combined to identify a pharmaceutical product or a pharmaceutical agent (API). The choice of method depends on the structure of the molecule and the respective pharmacopoeia monograph (e.g. USP, European pharmacopoeia).

1. Spectroscopic Methods

• Fourier Transform Infrared Spectroscopy (FTIR): Is considered the "fingerprint" of the molecule. By analyzing the vibration bands of the functional groups, it is proven that the substance exactly matches the standard reference material. Is often used in solid, liquid and semi-solid formulations.
• UV-Vis spectrophotometry: Measures in particular the absorption of molecules containing chromophore groups at specific wavelengths. Ideal for rapid screening.
• Narricity Resonance (NMR): The most meaningful technique for elucidating the molecular structure. is used in GLP studies in particular to verify complex molecules.

2. Chromatographic Methods

High Performance Liquid Chromatography (HPLC): Identity verification is usually done by comparing the retention times. The time the sample shows a peak must match the time the reference standard shows a peak.

Thin-layer chromatography (TLC): This is a cost-effective and effective method, in particular for identifying products of plant origin and certain excipients. The RF values are compared.

3. Thermal Analysis and Miscellaneous

• Differential Scanning Calorimetry (DSC): It is of crucial importance in the analysis of polymorphisms (different crystal structures of the same molecule). Melting point and enthalpy values indicate that the product is in the correct crystal form.

GLP compliant identity checks with nano test

In view of the increasing acceleration of drug development processes, the primary goal is not to compromise on the accuracy of the analysis results. Nano-Test is characterized by its state-of-the-art technological infrastructure and its specialists in the pharmaceutical industry and is your reliable partner for GLP-compliant identity checks.

Description of Nano-Test services:

NANO-TEST provides its services in laboratories equipped with the latest analyzers and fully comply with the standards of Good Labor Practice (GLP) and the ISO/IEC 17025 standard. Our service portfolio includes identity checks in accordance with all pharmacopoeia monographs, including FTIR, HPLC, GC-MS, LC-MS/MS, DSC and NMR.

As a nano test, we not only provide an analysis result, but a complete GLP conformity report, which ensures the data integrity (Alcoa+ principles), has an audit trail (Audit Trail) and is recognized by international authorities. Verify the product identity along your entire supply chain - from incoming raw materials control to finished product release tests - with Nano-Test's warranty.

Why nano test?

• Fast feedback: Automated sample preparation systems shorten the standard analysis times.
• Team of Experts: Employees with over 15 years of experience in pharmaceutical analytics.
• Manoration of regulations: Full compliance with current ICH, USP, EP and FDA guidelines.

The safety of a pharmaceutical product begins with its correct identification. GLP-compliant pharmaceutical identity checks provide scientific evidence that the product is the molecule specified in the formulation. Incorrect identification can lead to recall costs in the millions and endanger the patient's health. In a time when regulatory requirements are getting stricter day by day, working with a reliable and fully GLP-compliant partner like Nano-Test is the most sensible way to protect your brand's reputation and public health.