Quality Management System

As our mission statement reads “Commitment to excel in Quality" We believe that Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution. It represents the wise choice of many alternatives. Over the years the JV has nurtured a culture of quality in its endeavor.

Our Quality Management Systems (Pharmaceutical Quality Systems) are established according to National and International Health Authority Requirements and ISO 9001 standards.The Quality Management Systems encompass all the GMP relevant functions of the organization.

The quality systems such as Change Control, Deviations, OOS complaints are in Electronic Management Systems and facilitates transparency and traceability of the quality events.

The process performance & product quality is monitored through Quality Management Systems. The effectiveness of Quality Management System is periodically measured for continual improvement.

QC laboratory is in place to control the quality of incoming materials, in-process samples, intermediates, Active Pharmaceutical Ingredients and stability analysis.

The laboratory is well equipped with sophisticated analytical instruments such as High Pressure Liquid Chromatography (HPLC with PDA, RI, ELS detectors), GAS Chromatography (GC) with auto sampler and Headspace injection facility, Atomic Absorption Spectrometer (AAS) , Inductively Coupled Plasma Spectrometer (ICP), Fourier Transform Infra Red Spectrometer (FTIR), Differential Scanning Coulometer (DSC), Laser diffraction Particle Size Analysers, Alpine Air Jet Sieve analyzer, Hot Stage Melting Point Apparatus, Fluorescence Spectrophotometer, Camag TLC Applicator / DC Viewer, Ultra Violet -Visible Spectrophotometer and Thermo Gravimetric Analyzer.

A well equipped Microbiology lab is established for bioburden and endotoxin testing.

The QC laboratory is self sufficient to carry out all the required analyses.

 

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Takeda Pharma