GMP Manufacturing Quality Assurance and Quality Controls at Apurun

  • Initial Assessment: Evaluate formulation, process, and analytical methods.
  • Feasibility Study: Assess scalability and equipment compatibility.
  • Protocol Development: Create detailed transfer plan, timelines, and criteria.
  • Documentation and Training: Prepare comprehensive documentation and provide personnel training.
  • Execution of Transfer: Implement transfer process, monitor parameters, and conduct validation studies.
  • Process Optimization: Continuously improve efficiency and product quality.
  • Regulatory Compliance: Ensure adherence to regulatory requirements throughout the process.
  • Post-Transfer Support: Provide ongoing assistance and conduct reviews for continued success.

At Apurun, we take pride in offering GMP manufacturing services for pharmaceutical nanoparticle drug products across all formulation scales. With our fully compliant quality assurance department on-site, we ensure the highest standards of quality and regulatory compliance throughout the manufacturing process. Here's an overview of our comprehensive quality assurance and quality control procedures:

Quality Assurance:

  • Regulatory Compliance: Adherence to GMP guidelines and regulations to ensure product safety and efficacy.
  • Document Control: Implementation of robust document control procedures to manage manufacturing records and ensure accuracy and traceability.
  • Personnel Training: Ongoing training programs for staff to maintain proficiency and stay updated on current regulations and best practices.
  • Facility Monitoring: Regular monitoring and maintenance of manufacturing facilities to ensure cleanliness, sterility, and compliance with environmental controls.

Quality Controls:

  • Raw Material Testing: Comprehensive testing of raw materials to verify identity, purity, and quality before use in manufacturing processes.
  • In-process Controls: Continuous monitoring and testing of critical parameters during manufacturing to ensure product consistency and quality.
  • Finished Product Testing: Rigorous testing of finished products using validated analytical methods to confirm identity, potency, purity, and safety.
  • Stability Studies: Conducting stability studies to evaluate product shelf-life and ensure product quality over time.
  • Microbiological Testing: Testing for microbial contamination to ensure product sterility and compliance with regulatory requirements.
  • Environmental Monitoring: Regular monitoring of manufacturing environments for microbial contamination and particulate matter to maintain cleanliness and sterility.

Infrastructure for Manufacturing and Sterile Fill Finish:

  • State-of-the-Art Facilities: Equipped with advanced manufacturing equipment and technology to support GMP-compliant production.
  • Sterile Fill Finish Capabilities: Infrastructure for sterile fill finish operations, including aseptic filling and packaging of nanoparticle drug products.
  • Cleanrooms and Controlled Environments: Designated cleanrooms and controlled environments to ensure the integrity and sterility of manufactured products.

At Apurun, our commitment to quality assurance and quality control is paramount. With our comprehensive approach to GMP manufacturing, we guarantee the production of pharmaceutical nanoparticle drug products that meet the highest standards of quality, safety, and efficacy. Trust Apurun for your GMP manufacturing needs, and let us be your partner in delivering innovative and reliable pharmaceutical solutions.