USA’s health regulator has disapproved of manufacturing standards at GPT Pharmaceuticals' Hyderabad plant, warning it will withhold approval for the company’s new products if it doesn’t fix matters.
The Food and Drug Administration (FDA) said its investigators inspected the plant between June 24 and 28 last year and found numerous violations, including failure to ensure manufacturing standards and meeting established specifications for identity, strength, quality, and purity.
"Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements," said the regulator in a letter to the company's managing director Ashok Adityan.
"Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new drug applications or supplements listing your firm as a drug manufacturer," the letter said, referring to the regulator’s guidelines on good manufacturing. The company has 15 working days to respond.
It asked the company to provide its corrective and preventive action (CAPA) plan to implement routine, vigilant operations management oversight of facilities and equipment.
"Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records." Another important issue flagged by the US health regulator pertained to data integrity.
"Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture," the letter said.
It said it has reviewed company's July 17 response to its Form FDA 483 in detail and also acknowledged receipt of the firm's subsequent correspondence.