At ITAAN PHARMA, the QA, Microbiology, and QC departments function collaboratively as a Quality Unit to ensure patient safety, efficacy, quality and compliance with global regulations. 

Quality Assurance (QA): The Quality Assurance (QA) Department ensures that all products are manufactured, tested, and distributed in compliance with global regulatory guidelines and that the quality management system (QMS) is implemented effectively. The group's responsibilities include GMP oversight, batch record review and release, change control and risk management, deviation, failure, and CAPA management, regulatory compliance and continual audit readiness, vendor qualification and supplier audits, personnel training and documentation, and contamination control.

R&D Quality Assurance: Our R&D QA plays a critical role in ensuring that the development of new products, processes, and technologies adheres to strict regulatory standards, industry best practices, and internal quality systems.

Microbiology Department: The team oversees site sterility and microbial controls. Routine responsibilities include sterility testing, endotoxin testing, microbial limit testing, bioburden testing, growth promotion testing, environmental monitoring (viable and non-viable), surface monitoring, personnel aseptic training, and personnel monitoring to ensure a contamination-free environment. They also ensure that purified water (PW) and water for injection (WFI) comply with microbiological specifications.

Quality Control (QC): The department analyzes raw materials, in-process samples, finished products, and packaging materials with qualified analytical methods to ensure compliance with specifications (pharmacopeial standards and in-house). QC is also responsible for conducting ICH stability studies under different storage conditions. Our analytical lab is equipped with cutting-edge instruments such as:

• High-Performance Liquid Chromatography (HPLC)
• Gas Chromatography (GC)
• Fourier-Transform Infrared Spectroscopy (FTIR)
• UV-Vis Spectrophotometer
• Inductively Coupled Plasma Mass Spectrometry (ICP-MS) (for elemental impurities)
• Total Organic Carbon (TOC) Analyzer (for water quality testing)

By maintaining a world-class quality unit infrastructure, ITAAN PHARMA upholds its commitment to delivering safe and effective injectable products that meet the highest regulatory and science-based decision-making standards.