GMP Raw Material Certification Testing
The Good Manufacturing Practice (GMP) Raw Material Certification Testing service ensures that pharmaceutical raw materials meet stringent quality standards and regulatory requirements. This is critical for maintaining the integrity, safety, and efficacy of final products in the pharmaceutical industry.
Our testing aligns with international standards such as ISO 14001, ISO 9001, and GMP guidelines to ensure that the raw materials used in your formulations are safe, stable, and consistently produced. We conduct a comprehensive suite of analyses including physical, chemical, microbiological, and toxicological tests.
Our approach starts with an in-depth understanding of your product’s formulation and intended use. This helps us tailor our testing to meet the specific requirements of your raw materials. Our team uses state-of-the-art equipment such as HPLC, GC-MS, FTIR, and other advanced analytical tools to ensure precision and accuracy.
The GMP compliance process involves several key steps:
- Material sampling
- Initial inspection for purity and identity
- Physical property testing (particle size, moisture content)
- Chemical analysis (assay, impurities, degradation products)
- Microbiological testing (bacteria, fungi, viruses)
- Toxicological evaluation (重金属
