INVESTIGATION REPORT FOR WRONG EXPIRY DATE PRINTED DURING SECONDARY PACKING STAGE
During in-process inspection on 27/10/2025, it was observed that the secondary carton of Calcium Carbonate 500…
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NON CONFIRMANCE
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INVESTIGATION REPORT FOR THE RECORDED OF WRONG FILL VOLUME
During the audit, it was identified that the line clearance and in-process check sheet indicated a fill volume…
INVESTIGATION REPORT FOR TREND ANALYSIS RESULT OF PH TEST FOUND OUT OF LIMIT DURING REVIEW OF PHASE III WATER REPORT
During the routine review of the Phase III purified water report, the pH value was found out of the specified…
INVESTIGATION REPORT FOR THE UNAVAILABILITY OF DAILY TEMPERATURE MONITORING RECORD FOR REFRIGERATOR
As per GMP requirements and company SOPs, refrigerators used for pharmaceutical raw materials, intermediates,…
INVESTIGATION REPORT FOR MARKET COMPLAINT FOUND GHOST PILLS (EMPTY SHELLS) IN STOOL
The complaint received on 10/09/25 from the market indicated that patients noticed empty pill shells (ghost…
INVESTIGATION REPORT FOR GREEN-COLOURED ALGAE FOUND ON THE WALL OF WATER MANUFACTURING AREA
• During routine inspection of the Water Manufacturing Area on 10/07/2025, green-coloured algae growth was…
INVESTIGATION REPORT FOR THE WATER SANITIZATION FAILURE AS PER DEFINED FREQUENCY
As per the approved SOP, the purified water system is required to be sanitized once every 15 days using a…
INVESTIGATION REPORT FOR THE AIR CURTAIN OF BATCH DISPATCH AREA NOT WORKING
Air curtains are critical in pharmaceutical manufacturing shopfloors, especially in the Batch Dispatch Area, to…
INVESTIGATION REPORT FOR FLY KILLER NEAR DISPENSING AREA WAS NOT IN WORKING CONDITION
Fly killers are installed in manufacturing and dispensing areas to control insect contamination and maintain a…
INVESTIGATION REPORT FOR LOGBOOK FOR CHEMICAL OPEN AND CLOSE STATUS DID NOT CONTAIN
As per Good Documentation Practices (GDP) and SOP on Logbook Management and Chemical Handling, every chemical…