Purity Tests in Pharmaceuticals under GLP

What are Pharmaceutical Purity Tests?

What is GLP and Why is it Important?

GLP (Good Laboratory Practice) is a system that ensures that analysis and testing conducted in a laboratory environment are carried out in accordance with the principles of quality, reliability, and traceability.

In the quality control process of pharmaceutical products, GLP-compliant analyses are mandatory in order to obtain data that is both safe for the product and accepted by legal authorities.

What are Pharmaceutical Purity Tests?

Purity tests are analyses performed to identify and measure the quantities of undesirable impurities in a pharmaceutical product. These tests:

• Evaluate product quality
• Identify substances that may impair efficacy
• Analyze components that may pose a toxicological risk
• Scientific data is provided for licensing files

Key Elements to Consider in Purity Testing Under GLP

The following points are essential in purity testing conducted according to GLP standards:

• Use of standardized methods (e.g., USP, Ph. Eur.)
• Calibrated instruments and validated methods
• Traceability of sample collection, preparation, and storage conditions
• Complete and unalterable record keeping
• Review of results by quality assurance

Which Regulations Must Purity Tests Comply With?

• ICH Q3A/B/C: Organic and inorganic impurity limits
• USP and European Pharmacopoeia: Specific monographs
• EMA/FDA Licensing Criteria
• GLP Inspection Guidelines (OECD 1-14 Series)

What does GLP provide?

Purity tests conducted under GLP:

• Provide legally valid reports
• Increase the scientific reliability of licensing files
• Create transparency and trust during inspections
• Add quality assurance to the product development process

GLP-Compliant Purity Analyses with Nanolab

Nanolab performs purity analyses for pharmaceutical products in accordance with GLP rules. Tests conducted using HPLC, GC, ICP-MS, and spectrophotometric methods are carried out in accordance with validated and traceable processes.

With our expert team and accredited laboratory infrastructure, we clearly define the quality profile of your products and provide reporting services that are compliant with domestic and international authorities.

Nanolab Laboratories Group continues to provide services within the scope of Pharmaceutical Analysis.