The Laboratory Unit at Nogen Pharmed Caspian Company plays a critical role in ensuring the quality and safety of our products. This unit comprises specialized laboratories, including a dedicated Microbial Control Laboratory.
The Instrumental and Physicochemical Laboratories at Nogen Pharmed Caspian Company are equipped with advanced instrumentation to conduct a comprehensive range of analyses on raw materials, packaging materials, and finished products.
All analyses are performed in strict accordance with validated Standard Operating Procedures (SOPs) derived from the latest editions of internationally recognized pharmacopoeias such as the European Pharmacopoeia (EP), British Pharmacopoeia (BP), and United States Pharmacopoeia (USP).
Microbial Control Laboratory The Microbial Control Laboratory is responsible for safeguarding the sterility and microbiological quality of our products throughout the manufacturing process. Its key functions include: Microbial Testing:
Conducting a comprehensive range of microbiological tests on raw materials and finished products in accordance with international pharmacopoeial guidelines.
Performing periodic testing to confirm the absence of microbial contamination.
Standard Operating Procedures (SOPs):
Developing and maintaining comprehensive SOPs for all microbial control activities, ensuring consistency with international pharmaceutical standards.
Regularly reviewing and updating SOPs to reflect best practices and evolving regulatory requirements.
Packaging and Equipment Validation:
Validating cleaning and sterilization methods employed for packaging materials and production equipment.
Ensuring the effectiveness of these methods in preventing microbial contamination.
Validation Testing:
Conducting validation studies to verify the efficacy of sterilization and sanitation procedures.
Continuous Improvement:
Utilizing cutting-edge pharmacopoeial methods for all microbiological testing to maintain the highest standards of quality control.
Raw Material & Packaging Analysis
Comprehensive chemical testing of incoming materials to ensure compliance with specifications.
Finished Product Testing
Complete analysis of finished products to verify conformity with quality standards.
Stability Testing
Robust programs (accelerated, long-term, periodic) to guarantee product quality throughout shelf life.
SOP Management & Sampling
Developing/maintaining SOPs aligned with best practices and implementing standardized sampling protocols for accurate analysis.
Laboratory Unit
Nogen Pharmed Labs: Pharmacopoeia compliant, quality guaranteed
The Instrumental and Physicochemical Laboratories are vital to maintaining the highest quality standards for our products. Through meticulous analysis, adherence to international regulations, and ongoing collaboration with educational institutions, these laboratories contribute significantly to the company’s commitment to excellence.
In-Process Quality Control (IPQC) Laboratory The In-Process Quality Control (IPQC) Laboratory plays a critical role in ensuring the consistent quality of our products throughout all stages of the manufacturing and packaging processes. This department is dedicated to the rigorous implementation of Good Manufacturing Practices (GMP) regulations in all production activities, from the initial weighing of raw materials to the final packaging of finished products. The key responsibilities of the IPQC Laboratory include: Production Supervision:
This ensures adherence to established procedures and GMP principles.
Providing continuous oversight of all production activities, including the weighing of raw materials, product manufacturing at each stage, and final packaging.
Maintaining strict quality control by monitoring the performance of production equipment throughout the manufacturing process.
Standard Operating Procedures (SOPs):
Developing and maintaining comprehensive SOPs for all in-process quality control activities, ensuring alignment with international pharmaceutical standards and GMP regulations.
These SOPs are regularly reviewed and updated to reflect best practices and evolving regulatory requirements.
Final Product Sampling:
Implementing a robust sampling program to collect representative samples of finished products from all production lines for further analysis by the Quality Control Laboratory.
By actively supervising production activities, ensuring adherence to GMP regulations, and maintaining accurate SOPs, the IPQC Laboratory plays a vital role in safeguarding the quality and consistency of Nogen Pharmed Caspian Company’s products.
