Last Updated on March 15, 2025 by The Health Master
Warning Letter
The US Food and Drug Administration (USFDA) has delivered a warning letter to Granules India, citing significant breaches in Current Good Manufacturing Practice (CGMP) at its Medchal-Malkajgiri formulations plant in Telangana.
The USFDA’s warning letter, highlights critical failures in maintaining building integrity and adhering to proper equipment maintenance and cleaning procedures.
This development raises concerns within the pharmaceutical industry and highlights the importance of rigorous quality control.
Key Findings:
The USFDA inspection, conducted from August 26 to September 6, 2024, revealed alarming levels of contamination within the facility’s air handling units (AHUs).
Despite the presence of filters designed to prevent contamination, inadequate cleaning and maintenance rendered them ineffective.
Must read: AHUs, Air Types, Air Changes and their Functions in Pharma Industry
- Contaminated Ducts: Inspectors discovered significant contamination in multiple non-dedicated ducts used in the production of finished drug products.
- Microbial and Drug Residue: Swab samples taken from the ducts, particularly after the high-efficiency particulate air (HEPA) filters, showed residues from previously manufactured drugs and an overwhelming amount of microbial contamination.
- Facility Deterioration: The USFDA noted the presence of bird droppings and feathers within the AHU area, indicating a failure to maintain the building in a state of good repair. This is a crucial aspect of pharmaceutical manufacturing that needs to be addressed immediately.
Record-Keeping Lapses and Data Integrity Concerns
Beyond physical contamination, the USFDA also raised serious concerns about Granules India’s record-keeping practices.
The discovery of torn CGMP records in waste bags, including analytical balance printouts and worksheets containing manufacturing and testing data, points to significant data integrity issues.
- Compromised Data Integrity: The USFDA stated that the company’s quality system fails to ensure the accuracy and integrity of data, which is crucial for guaranteeing the safety and efficacy of manufactured drugs.
USFDA Demands Corrective Action
The USFDA has mandated that Granules India provide a detailed plan and timeline for implementing robust operations management oversight of its facilities.
This plan must address several key areas:
- Prompt Detection of Contamination: Systems to quickly identify and address facility contamination issues.
- Effective Repairs: Timely and efficient execution of necessary repairs.
- Preventive Maintenance Schedules: Adherence to appropriate preventive maintenance schedules.
- Technological Upgrades: Timely upgrades to facility infrastructure.
- Improved Management Review: Enhanced systems for ongoing management review.
Consequences and Future Actions
The USFDA has made it clear that failure to address these deviations could result in the withholding of approvals for new drug applications or supplements listing Granules India as a manufacturer.
The agency may also conduct a re-inspection to verify the implementation of corrective actions.
Granules India has been given 15 working days to respond to the warning letter and outline the steps taken to address the identified violations and prevent their recurrence.
Q. What is CGMP?
A. CGMP stands for Current Good Manufacturing Practice. It refers to regulations enforced by the USFDA to ensure that pharmaceutical products are consistently produced, controlled and stores according to quality standards.
Q. What happens if a company fails to comply with USFDA regulations?
A. Failure to comply with USFDA regulations can result in warning letters, product recalls, import bans, and even legal action.
Q. Why is data integrity so important in pharmaceutical manufacturing?
A. Data integrity ensures that all records and data related to drug manufacturing are accurate, complete, and reliable, which is essential for ensuring product quality and safety.
Q. What is an AHU?
A. An Air Handling Unit (AHU) is a device used to regulate and circulate air as part of a heating, ventilating, and air-conditioning (HVAC) system.
Q. What are HEPA filters?
A. HEPA stands for High-efficiency particulate air. HEPA filters are air filters that remove at least 99.97% of dust, pollen, mold, bacteria, and any airborne particles with a size of 0.3 microns (µm).
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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