The FDA recently wrote to Sun Pharmaceutical about ongoing violations of Current Good Manufacturing Practices that they are failing to address despite having already been warned.
Excerpts:
1. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b))….
4. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192)….
5. 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 (21 CFR 211.67(a))….
…Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accordance with CGMP. In addition to the lack of effective oversight of production operations to ensure reliable facilities and equipment, we found your QU is insufficiently resourced or enabled with authority to carry out its responsibilities. Furthermore, internal communications and systems were not implemented by management to ensure all levels of the company can effectively identify major quality risks so they are promptly escalated to senior management, whenever needed. You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems, processes, and the products manufactured conform to FDA requirements.
