Pharmaceutical Quality System (PQS) at Odhav Pharma
Odhav Pharma upholds a robust Pharmaceutical Quality System (PQS) that adheres to global regulatory standards. With stringent quality controls and a focus on continuous improvement, we ensure our products deliver the highest levels of safety, efficacy, and reliability.
Audit Management & Regulatory Compliance
Regular audits are conducted across all Odhav Pharma facilities to evaluate compliance with both national and international regulatory standards.
Change Management
Timely and effective changes are managed through a robust change control system, carefully evaluated by expert teams to drive continuous improvement.
Continual Improvement
Continuous improvement and product quality are ensured through PQS tools like Change Management and CAPA.
CAPA Management
A structured Corrective and Preventive Actions (CAPA) strategy is implemented to drive continuous process improvement and reinforce operational procedures.
Deviation and Incident
A structured approach is followed to address deviations and incidents, supporting continuous improvement of procedures.
Knowledge Management
A systematic approach is adopted to gain knowledge through regulatory updates, external training, and engagement with regulatory consultants.
Management Review and Monitoring
Periodic assessments are conducted to evaluate PQS performance and ensure appropriate resource allocation for its continual enhancement.
Quality Objective
An effective PQS is implemented to achieve quality objectives through the adoption of a Quality Policy, Quality Planning, and key PQS tools.
Quality Commitment
A structured approach is followed to manage deviations and incidents, driving continuous improvement of procedures.
Quality Risk Management
A strong proactive approach is employed to identify, scientifically assess, and control potential risks during manufacturing, ensuring product quality, patient safety, and overall health.
Risk Management
Potential risks are scientifically evaluated, and appropriate mitigating actions are implemented to advance to the next level of quality.
Root Cause Analysis and Investigations
A systematic approach is used to identify and analyze root causes through various investigational tools, aiming to prevent recurrence of issues.
Advanced Quality Control (QC) Labs
Chemical Analysis
We perform advanced analytical testing using a wide range of sophisticated techniques, including HPLC, UPLC, GC, FTIR, UV, ICP-OES, ICP-MS, GC-MS, LC-MS, and Laser Diffraction. These technologies enable precise and accurate analysis to ensure the highest quality standards across all our products.
Microbiological Testing
We conduct rigorous testing for microbial contamination to ensure the safety and integrity of both sterile and non-sterile formulations. Our microbiology labs are equipped with advanced instruments such as Auto Culture Identifiers and Rapid Sterility Testers, enabling accurate, efficient, and reliable microbial analysis.
Stability Testing
Stability testing is carried out in accordance with ICH guidelines across various climatic zones to ensure product stability, quality, and efficacy throughout their shelf life, no matter where they are distributed globally.
Elemental, Genotoxic & Nitrosamine Impurity
We identify, quantify, and control undesired impurities generated during processing to ensure product purity and safeguard patient health and safety. Ask ChatGPT