Quality is Non-Negotiable
At Nishcura Healthcare, compliance is the foundation of everything we do. Our quality systems, policies, and culture are designed to protect patients and build lasting regulatory trust.
Manufacturing Under International GMP Standards
Good Manufacturing Practices form the bedrock of pharmaceutical quality at Nishcura Healthcare. Our facilities, systems, and processes are designed, qualified, and operated in accordance with WHO Technical Report Series guidelines and current GMP expectations worldwide.
We maintain a robust Quality Management System (QMS) that governs all aspects of our operations — from personnel hygiene and training to equipment qualification, process validation, and change control. Our documentation system ensures traceability, accountability, and consistency at every step.
Annual Product Reviews (APR), periodic self-inspections, and management review meetings form the cornerstone of our continuous improvement culture. Our CAPA system ensures that deviations are rigorously investigated and preventive actions are systematically implemented.
ALCOA+ Framework
Nishcura Healthcare adheres to the internationally recognized ALCOA+ principles for pharmaceutical data integrity, ensuring that all data generated during manufacturing and testing activities is trustworthy and reliable.
Our Regulatory Commitments
Nishcura Healthcare maintains clearly defined policies aligned with the latest regulatory expectations from global health authorities.
Quality Policy
Nishcura Healthcare Pvt Ltd is committed to manufacturing pharmaceutical products that consistently conform to established specifications and quality standards. Our Quality Policy is anchored in a systematic approach to quality management, continuous improvement, and regulatory compliance. We ensure that every product released from our facility is safe, effective, and of the highest quality.
- Systematic quality management at every stage
- Regular internal audits and management reviews
- Continuous improvement through CAPA system
- Employee training and GMP awareness programs
Nitrosamine Control Policy
In response to evolving regulatory guidance from FDA, EMA, and CDSCO on nitrosamine impurities, Nishcura has implemented a comprehensive Nitrosamine Drug Substance Related Impurity (NDSRI) control policy. We conduct risk assessments for all products and implement appropriate analytical controls.
- Nitrosamine risk assessment for all products
- Raw material and process evaluation
- Validated analytical methods (LCMS/HPLC)
- Acceptable Intake (AI) limit compliance
Elemental Impurity Control
Compliant with ICH Q3D guidelines, our Elemental Impurity Control Policy establishes threshold limits and analytical strategies for elemental impurities in pharmaceutical products. We conduct systematic risk assessments for Class 1, 2A, 2B, and 3 elemental impurities across all product categories.
- ICH Q3D risk-based assessment
- ICP-MS/OES analytical capabilities
- Component-level impurity mapping
- Ongoing monitoring and periodic review
Glass & Metal Contamination Prevention
Our contamination prevention program encompasses physical containment controls, in-process inspections, and validated detection systems. For injectable products, 100% visual inspection is performed, and all glass-contact packaging materials are qualified to pharmacopeial standards for hydrolytic resistance.
- Metal detector qualification and use
- Filter integrity testing protocols
- 100% visual inspection for parenterals
- Glass qualification per USP/Ph.Eur standards
Our Promise to Patients
Every product manufactured at Nishcura Healthcare is backed by a commitment to quality that goes beyond regulatory compliance — it is a moral obligation to the patients who depend on our medicines for their health and well-being.
