Quality Control

 

At Pearl Pharmaceuticals, our Quality Control (QC) Department is dedicated to ensuring that every product meets the highest standards of purity, potency, and safety. Through rigorous testing and advanced analytical techniques, our QC team guarantees that all raw materials, in-process samples, and finished pharmaceutical products comply with international quality standards.

Key Responsibilities of the QC Department:

 

1. Raw Material & In-Process Testing:

   • Conducting chemical, physical, and microbiological analysis of raw materials, excipients, and packaging components.
   • Monitoring in-process samples to ensure consistency and compliance with specifications.

2. Finished Product Analysis:

   • Performing stability studies, dissolution tests, and impurity profiling to ensure the efficacy and safety of final products.
   • Verifying the uniformity, strength, and integrity of each batch before market release.

3. Advanced Instrumentation & Techniques:

   • Utilizing state-of-the-art equipment such as HPLC, FTIR, UV Spectroscopy, Karl fisher, dissolution apparatus, TOC, LPC, viscometer, polarimeter etc. and Microbiological Testing Methods for precise analysis.
   • Implementing modern techniques for impurity detection, heavy metal testing, and dissolution profiling.

4. Regulatory Compliance & Documentation:

   • Maintaining detailed batch records, COAs (Certificates of Analysis), and SOPs (Standard Operating Procedures).
   • Ensuring compliance with cGMP, WHO, FDA and other regulatory standards through internal and external audits.

5. Environmental & Microbiological Monitoring:

   • Conducting sterility testing and microbial limit testing for contamination control.
   • Monitoring air, water and surface quality to ensure a sterile and controlled production environment.

6. Continuous Improvement & Corrective Actions:

   • Identifying deviations and implementing CAPA (Corrective and Preventive Actions) for process improvement.
   • Collaborating with the Quality Assurance team to enhance production efficiency and maintain compliance.

At Pearl Pharmaceuticals, our QC Department ensures that every product leaving our facility is safe, effective, and of superior quality, reinforcing our commitment to excellence in healthcare.