Maharashtra FDA has issued a show cause notice to a Nashik based firm for not complying to quality control protocols and good manufacturing practices. It was found during inspection that quality control officers were absent in the second and third shift and that explosive solvents like lsopropyl alcohol were stored in open space among other violations.
The firm is a WHO-GMP certified unit and is leading exporter to several countries.
Show cause notice was served for contravening the provisions of Section 18 (c) Rule 74, 78(p) of the D&C Act and various provisions of Schedule M Part I and Schedule Ll.
Based on FDA inspection, it was also found that the firm had not provided separate sampling area for active raw materials and excipients. Other major contraventions included log book for equipment were not in place, hygrometers did not have water, environmental control were not validated periodically, vendor validation records were not produced during inspection, air condition and lights were not found in working condition, no temperature and humidity records were available, overhead and underground water tanks were not cleaned periodically.
Other violations are that required equipment for testing of the product as in microbiotogy section, Zone reader is not provided for Micro assay Zone of inhibition /exhibition measurement, calibration of auto micro pipette, sieve shaker and HPLC not done, I -source of reference microbiological cultures are not maintained.
In December 2012, the firm manufactured and distributed two batches of product namely Joykid Suspension (paracetamol and lbuprofen suspension) of batch size of 600 litres each without taking product permission from the FDA, Nashik. The said manufacturer also did not prepare any document regarding batch manufacturing record, testing of the product and did not maintain distribution records.
In October 2016, the vigilance branch of Maharashtra FDA got information about some clandestine operations in the firm. Accordingly, a team of assistant commissioner, intelligence branch, headquarter along with the drugs inspectors of Nashik division under joint commissioner (vigilance) Harish Baijal inspected the factory premises and found that the company had contravened the legal provisions of Drugs and Cosmetics Act 1940 and Rules there under.
As per the WHO, GMPs include factors such as sanitation and hygiene, qualification and validation, self-inspection, quality audits, suppliers’ audits, prevention of cross-contamination and bacterial contamination during production, training employees and personal hygiene.