Raw Material Inspection

  • Verify the quality of incoming raw materials to ensure they meet specifications.
  • Check for consistency and purity of raw materials.

Process Control

  • Implement control measures at each stage of manufacturing to maintain consistency.
  • Monitor critical process parameters to ensure they are within specified limits.

In-process Testing

  • Conduct regular tests during production to identify and rectify any deviations.
  • Monitor reaction kinetics, temperature, pressure, and other relevant parameters.

Analytical Testing

  • Perform comprehensive analysis of final products to confirm compliance with specifications.
  • Use techniques such as chromatography, spectroscopy, and titration for accurate results.

Quality Assurance Documentation

  • Maintain detailed documentation of manufacturing processes and quality control procedures.
  • Ensure compliance with regulatory requirements and industry standards.

Batch Sampling

  • Take representative samples from each batch for testing and validation.
  • Retain samples for reference and future analysis.

Equipment Calibration

  • Regularly calibrate production equipment to maintain accuracy.
  • Ensure that instruments used for testing are calibrated regularly.

Environmental Monitoring

  • Monitor environmental conditions in manufacturing areas to prevent contamination.
  • Implement measures to control factors such as humidity and temperature.

Packaging Integrity

  • Inspect packaging materials for integrity and compliance with safety standards.
  • Ensure correct labeling and batch coding.

Final Product Inspection

  • Conduct a final inspection of finished products to verify quality.
  • Check for any visual defects and ensure packaging is intact.

Stability Testing

  • Assess the stability of products over time under various conditions.
  • Ensure products remain effective and safe throughout their shelf life.

Regulatory Compliance

  • Regularly audit processes to ensure compliance with regulatory requirements.
  • Stay informed about changes in regulations and adjust processes accordingly.

Training and Certification

  • Provide ongoing training for staff involved in manufacturing and quality control.
  • Ensure personnel are certified and follow Good Manufacturing Practices (GMP).

Continuous Improvement

  • Establish a system for feedback and continuous improvement.
  • Identify areas for optimization and implement corrective actions.