GMP Compliance for Sterile Drug Products: A Regulatory Prospectives
The Current Good Manufacturing Practices (CGMP) regulation for human pharmaceuticals is the most important regulatory standard for ensuring pharmaceutical quality. When Company has to manufacture a sterile drug product in the manufacturing plant so the company needs GMP certification that why the company calls to FDA to conduct an inspection by the Agency's investigator of the manufacturing site of sterile drug products as part of the cGMP compliance verification. Due to the
violation of cGMP the FDA issued more warning letters and form 483 to finish product manufacturers. FDA has given 15 working days to the firm management for responding Form 483 and describing the cause for non-compliance, and necessary corrective action taken to prevent the recurrence. If the response is not satisfactory, the FDA agency sends warning letters to the manufacturers.
Result: This review highlights the current state of the top company that received warning letter and form483 in sterile drug products and fluctuating pattern of the warning letter and form 483.
Conclusion: This study indicates the major infringement of cGMP in sterile drug product, during the time of inspection over the past years. However, in 2020 slightly decreased the graph of warning letter. The reason for decreasing violation because the company meets cgmp guidelines and inspection results have been improved.