Quality Control SOPs & Procedures

Quality Control SOPs & Procedures:

Standard Operating Procedures (SOPs) and Procedures for Quality Control in Pharmaceutical Nanoparticles and LNPs Development and Manufacturing

Quality control is a critical aspect of pharmaceutical nanoparticle and LNP (Lipid Nanoparticle) development and manufacturing to ensure the safety, efficacy, and consistency of the products. At Apurun, we adhere to stringent SOPs and procedures to meet the highest quality standards in every stage of the process. Below are key SOPs and procedures implemented by Apurun:

1. Raw Material Inspection and Acceptance:
- SOP: This SOP outlines the procedures for inspecting and accepting raw materials used in nanoparticle and LNP manufacturing.
- Procedure: Each raw material undergoes a thorough inspection, including identity verification, purity testing, and documentation of specifications. Only approved materials meeting predetermined criteria are accepted.

2. Formulation Development and Optimization:

  • SOP: This SOP governs the formulation development and optimization process for nanoparticles and LNPs.
  • Procedure: Scientists follow a structured approach to design and optimize formulations, considering drug compatibility, excipient selection, and critical process parameters.


3. In-Process Quality Control (IPQC):

  • SOP: This SOP governs IPQC activities throughout nanoparticle and LNP production.
  • Procedure: During manufacturing, frequent quality checks are conducted, including particle size analysis, drug loading assessment, and homogeneity testing, to ensure product uniformity and adherence to set specifications.


4. Finished Product Testing:

  • SOP: This SOP outlines the testing procedures for the final nanoparticle and LNP products.
  • Procedure: The finished products undergo a battery of tests, such as particle size distribution, drug release profiling, and stability assessment, to verify the desired characteristics and performance.


5. Analytical Methods Validation:

  • SOP: This SOP details the validation of analytical methods used for quality control testing.
  • Procedure: Analytical methods employed for product testing are thoroughly validated to ensure accuracy, precision, and reliability.


6. Stability Studies:
- SOP: This SOP governs stability studies to assess product shelf-life and storage conditions.
- Procedure: Stability samples are periodically tested under various environmental conditions to monitor potential degradation and ensure product stability over time.

7. Documentation and Record Keeping:

  • SOP: This SOP covers documentation and record-keeping practices.
  • Procedure: Accurate and complete records of all quality control activities, including raw material testing, batch analysis, and stability studies, are maintained to comply with regulatory requirements.


8. Change Control and Deviation Management:

  • SOP: This SOP outlines the procedures for change control and deviation management.
  • Procedure: Any changes to processes, equipment, or specifications undergo thorough evaluation, and deviations are documented, investigated, and resolved promptly to maintain product quality and consistency.

9. GMP Compliance:

  • SOP: This SOP governs compliance with Good Manufacturing Practices (GMP) regulations.
  • Procedure: The entire nanoparticle and LNP manufacturing process is conducted in accordance with GMP guidelines to ensure quality, safety, and compliance with regulatory requirements.


At Apurun, we prioritize quality control at every stage of nanoparticle and LNP development and manufacturing. These SOPs and procedures are continuously reviewed and updated to reflect the latest industry best practices and regulatory requirements, ensuring our commitment to delivering safe and effective pharmaceutical products for our clients and patients.