An ISO9001 Certified Supplier of Pre-Clinical Contract Research Service and Analytical Service
Pharmaceutical companies are committed to ensuring the safety, efficacy, and quality of their products. Quality control testing of pharmaceutical products is essential for drug development from the early stages to commercial batch release, to ensure that the drugs produced meet the required standards and are safe to consume. Protheragen-ING Lab provides comprehensive and comprehensive services on quality control testing of pharmaceutical products to help our clients ensure the safety, efficacy, and quality of their drugs.
Importance of QC and QA in the pharmaceutical industry
- Patient Safety: Rigorous testing and quality assurance processes help identify and eliminate any potential risks associated with pharmaceutical products.
- Regulatory Compliance: Quality control and quality assurance practices help companies comply with these regulations, avoiding penalties, legal issues, and damage to their reputation.
- Product Efficacy: By monitoring critical quality attributes, such as potency and stability, companies can ensure that their products deliver the intended therapeutic effects.
- Brand Protection: By implementing robust quality control and quality assurance processes, companies can safeguard their brand image, ensuring consistent quality and customer satisfaction.
Comprehensive pharmaceutical quality control solutions
With our expertise in method development, method validation and batch release testing, Protheragen-ING Lab helps pharmaceutical companies meet regulatory requirements and maintain the highest standards of quality control.
Method development involves the design and optimization of analytical methods used for the analysis of pharmaceutical products. Our team of experienced scientists works closely with clients to develop robust and reliable analytical methods that meet specific requirements. We utilize advanced techniques and modern instrumentation to ensure accurate and precise results.
It involves demonstrating that an analytical method is suitable for its intended purpose and provides reliable and consistent results. Our service includes comprehensive method validation studies, following international guidelines such as ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). We conduct validation studies to assess parameters such as specificity, accuracy, precision, linearity, and robustness, ensuring that the methods meet regulatory requirements.
Our service includes a comprehensive range of lot release testing services, including tests for identity, strength, purity, and impurities. Our state-of-the-art laboratories are equipped with advanced analytical instruments and technologies to perform these tests accurately and efficiently. We follow strict protocols and adhere to regulatory guidelines to assure the quality and safety of pharmaceutical products.
Pharmaceutical guidelines for quality control
Protheragen-ING Lab is committed to maintaining the highest standards of quality control and compliance with drug quality control guidelines. We stay updated with the latest regulatory requirements and ensure that our testing methods and processes align with these guidelines.
- Good Laboratory Practices (GLP).
- Pharmacopeial Standards.
- ICH Guidelines.
- Validation Guidelines.
- Stability Testing Guidelines.
- Data Integrity Guidelines.
- Quality Risk Management.
Advanced instrument platforms
Our pharmaceutical quality control testing service is backed by a state-of-the-art instrument platform. We utilize advanced analytical instruments, such as high-performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry (MS), and atomic absorption spectroscopy (AAS), among others. These instruments offer high sensitivity, accuracy, and precision, enabling us to perform a wide range of analyses and deliver reliable results.
Contact us today to discuss your testing requirements and benefit from our expertise in pharmaceutical analysis and quality assurance.