Validation and Calibration

Critical equipments like weighing scales etc. are calibrated daily before the start of production activities. The laboratory equipments are calibrated / qualified / revalidated on a regular basis from time to time as per standard procedures and records maintained.

Process validation is done for every product for the first three batches by analyzing the bulk solution for thorough mixing or as the case may be.

Cleaning and Sanitation procedures of manufacturing areas and equipments are in place.

Standard cleaning procedures for equipment and areas are written and displayed.

Disinfecting agents for floors and walls are used alternatively every week.

The method of evaluating the effectiveness of cleaning is by microbial evaluation.

Microbiological methods like swab testing are carried out to monitor the efficiency of cleaning methods in critical areas like dispensing, processing areas etc.

Cleaning method for the water supply system: Overhead tank storing raw water is cleaned with disinfectants as per schedule.

Cleaning of Air Handling System Pre Filters

The pre filters of AHUs are removed for cleaning and are refitted with spare pre-fiilters. The cleaned pre-filters are then stored at appropriate place.