The QMS (Quality Management System) is established through document & data control. Regular inter-departmental self inspections, training of employee on GMP, hygiene and precaution against cross contamination and mix up are conducted.
The employee under-go medical examination once a year through registered medical practitioner, to establish there physical fitness/free from contagious diseases. Eye check up is followed for each employee deployed at optical checking work.
There is a well defined sanitization system which is followed in order (as and when applicable).
Qualifications and Revalidations of AHU and calibration of measuring devices are followed at definite interval of time, establishing uninterrupted quality/consistency of product.
The vendor’s approval system is established for material procurement and its quality consistency.
Water being the key raw material in pharmaceutical formulations is from municipal source.
Purified water generation, storage, volume and usage are thoroughly regulated by well defined water system, comprising of SS316 loop line/vessel system.
There is a well defined change control system which is followed in order (as and when applicable).
Quality Control Systems
The laboratory is well equipped comprising of sophisticated instruments viz. HPLC, FTIR, GLC and UV/VIS spectrophotometer to TOC analyser, liquid particle counters etc. besides chemical and micro-biological analysis.
Quality control of each input and finished product is subjected for analysis through written test specifications/methods as applicable (chemical / instrumental / micro-biological).
Sampling is followed as per established sampling plan which are in accordance with cGMP norms/ standard operating procedures.
Stability of finished products
The products are subjected for stability at accelerated conditions of temperature and RH. One batch every year for each product is subjected for real time study.