Guidance And Recommendations: Avoiding USFDA Warning Letters For A Cgmp Violation Pertaining To Sterile Products

The US FDA released guidelines for industry over 20 years ago. The guidance was titled “Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice September 2004”. The scope of this guideline is limited; it does not address all aspects of sterile product, including product processed by TS processing. The guidelines mostly deal with cGMP issues related to finished products, but they do not go into detail beyond the upstream bulk processing. The expectations of regulators and the procedures currently followed for sterile product facility inspections are not covered by this guidance.  To enhance understanding of the requirements for inspections of sterile product facilities, US FDA did not organized any training courses in specifically in India where largest sterile facilities are located.  Furthermore, there are no reports of Indian firms taking up any effort to provide this kind of training. Thus, guidelines needs to be introduced in order to address the challenges that sterile manufacturers are experiencing right now. Based on review of WLs issued to sterile products, a brief guideline is prepared. The guideline provides essential recommendations for sterile product facility inspections and can be used as a manual for preventing cGMP violations pertaining to sterile products. The guideline addresses several important topics pertaining to sterile products, for which the US FDA often issues warning letters: