Our management is dedicated to enhancing global healthcare by producing and delivering high-quality products at affordable prices to meet market demand. We emphasize the implementation of Current Good Manufacturing Practices (cGMP) at every level of the organization to ensure product quality, safety, and efficacy. Furthermore, we are committed to attracting and retaining top-tier professionals who exemplify service excellence. NBPL is devoted to continuous improvement in our processes, quality, and service through ongoing training programs.
We have meticulously implemented a robust quality management system to ensure full compliance with current regulatory standards and guidelines, including Schedule M, WHO-GMP, USFDA, EU-GMP, ICH, ISO, and more. This comprehensive system is designed to ensure that our APIs and intermediates are not only suitable for their intended use but also meet all regulatory requirements and guarantee exceptional levels of safety, quality, and efficacy.
Our quality management objective is achieved through an extensive, process-oriented approach that encompasses both internal and external processes. By maintaining rigorous standards and continuously enhancing our quality protocols, we ensure that our products consistently meet the highest industry benchmarks, providing our customers with reliable and effective pharmaceutical solutions.
At the heart of our operations, quality is meticulously engineered through thoughtful process design. To uphold our quality management system’s objectives, we employ a robust risk-based approach. We view changes in manufacturing processes during development and throughout the product lifecycle as valuable opportunities to acquire additional insights and further refine our design space.
Each change is carefully evaluated and consistently monitored, ensuring stringent process control. Our quality risk management strategy is a comprehensive and systematic process that encompasses the assessment, control, communication, and review of risks, safeguarding the quality of our drug products across their entire lifecycle.
At our facility, comprehensive Product Quality Reviews are conducted for every batch manufactured. These reviews are essential to validate the robustness of our Quality System, ensuring the highest standards of quality, purity, efficacy, safety, stability, and integrity of our products.
We meticulously gather trend data from Batch Manufacturing Records and Analytical Records, focusing on various critical parameters. Graphical representations are created to assess the consistency and reliability of our products. Each Product Quality Review culminates in a detailed report, summarizing findings and providing recommendations if necessary. This report undergoes thorough evaluation and approval by the Production Quality Assurance personnel.
Product Quality Reviews are integral to maintaining the excellence of our final products, reaffirming our commitment to quality and continuous improvement.
Our Quality Control (QC) department meticulously conducts comprehensive chemical examinations on a diverse range of raw materials, packaging components, and finished products, adhering to predefined standard test procedures and specifications. This includes rigorous sampling, testing and generation of status labels. QC makes critical decisions on subsequent actions based on results obtained at various stages, from procuring raw materials and packaging components in warehouses through in-process testing to the final dispatch of finished products.
Furthermore, QC is responsible for precisely calibrating all testing instruments, ensuring that they meet stringent accuracy standards. The department also validates newly developed analytical methods before their routine implementation, guaranteeing consistency and reliability. Our company adheres to a robust stability testing program based on ICH guidelines, with periodic reviews conducted by Quality Assurance (QA) to ensure ongoing product integrity and compliance.
Our self-inspection system is managed and controlled by the Quality Assurance (QA) team and ensures continuous compliance with cGMP standards. An annual self-inspection plan, meticulously prepared in advance, outlines the areas to be audited. These inspections are conducted by a cross-functional team of trained auditors, led by an experienced QA team member.
The purpose of self-inspections is to evaluate the effectiveness of our quality systems and their adherence to cGMP guidelines. Each audit report is followed by a compliance status report that details corrective actions, a time-bound schedule for completion, and preventive measures to avoid the recurrence of identified deficiencies. All actions are thoroughly documented and reported to the responsible area In-charge.
The QA In-charge ensures that audit recommendations are implemented by the respective departmental heads, maintaining our commitment to quality and continuous improvement.
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