PharmPure™: GMP grade biopharmaceutical Raw and Starting Materials from Aladdin Scientific
Overview:
PharmPure™ is a trademark representing a comprehensive range of biopharmaceutical raw and starting materials. Designed to meet the highest standards of quality and compliance, PharmPure™ products support various stages of biopharmaceutical manufacturing, from early development to high-risk applications. The PharmPure™ range is structured into three distinct levels: Genesis, Core, and Apex, each tailored to specific needs and risk levels in the biopharmaceutical manufacturing process.
PharmPure™ Levels:
PharmPure™ Genesis
For Early Stages of Biopharmaceutical Manufacturing
• Purpose: Ideal for initial stages of biopharmaceutical development, bridging the gap between lab-grade and GMP-compliant process raw materials.
• Features:
• Fills the gap between lab-grade and GMP-compliant process raw materials.
• Provides quality and supply chain documentation to support risk assessments for non-GMP process chemicals.
• Ensures high-quality raw materials for early-stage biopharmaceutical processes.
PharmPure™ Core
For Moderate Risk Applications
• Purpose: Designed for applications with moderate risk, ensuring compliance and quality for consistent and reliable results.
• Features:
• Compliance with IPEC-PQG GMP and EXCiPACT™ Quality Standards.
• Provides supply chain transparency and regulatory support to assist product qualification and formalized risk assessments.
• Ensures reliable and consistent quality for moderate risk biopharmaceutical applications.
PharmPure™ Apex
For High Risk Applications
• Purpose: Tailored for high-risk applications, providing the highest standards of compliance and minimal contamination levels.
• Features:
• Compliance with IPEC-PQG GMP, providing supporting documentation similar to PharmPure™ Core.
• Ensures the lowest microbial and endotoxin levels for high-risk applications.
• Offers comprehensive quality and safety assurance for critical biopharmaceutical processes.
Benefits of PharmPure™:
1. Regulatory Compliance:
• Ensures adherence to industry standards and regulations, facilitating smoother regulatory approvals and compliance.
1. Quality Assurance:
• Each product undergoes rigorous testing and documentation to ensure the highest quality and reliability, reducing risk and enhancing performance.
1. Comprehensive Documentation:
• Provides detailed documentation to support qualification, risk assessment, and process optimization, streamlining regulatory and operational processes.
1. Supply Chain Transparency:
• Maintains full supply chain transparency, ensuring traceability and accountability for all raw and starting materials.
Application:
PharmPure™ products are designed for biopharmaceutical manufacturers and researchers who require high-quality, compliant raw materials for various stages of drug development and production. Whether for early-stage research, moderate risk applications, or high-risk critical processes, PharmPure™ ensures that you have the right materials to achieve your goals.
Trademark Information:
PharmPure™ is a registered trademark, representing a commitment to excellence in biopharmaceutical raw and starting materials. By choosing PharmPure™, you are ensuring the integrity of your biopharmaceutical manufacturing process, supported by reliable, compliant, and high-quality materials.
By leveraging the PharmPure™ range, you can confidently navigate the complexities of biopharmaceutical manufacturing, ensuring successful outcomes and regulatory compliance at every stage.