Posted: 30 Sep 2015 09:21 PM PDT
By Douglas B. Farquhar –
Industry newsletter The Pink Sheet reports that, at a conference Monday, FDA said that investigators performing FDA inspections will likely be divided into “subspecialties within the various product groups.” Thanks for reporting that news, but we are not sure we agree with The Pink Sheet prediction that this development “surely will be welcomed by industry, because it could lead to smoother inspections.”
Notably, the announcement was made by FDA’s GDUFA (Generic Drug User Fee Act) staff director for the Office of Regulatory Affairs at FDA. She has been a very busy woman: the number of Warning Letters issued to drug manufacturers has mushroomed in recent years, and most of those letters have been issued to foreign generic drug manufacturers, or to the facilities that manufacture Active Pharmaceutical Ingredients (many of which are used in generic drug manufacturing). Indeed, we reviewed Warning Letters issued by FDA between July 1, 2013, and May 26, 2015, and of the 35 Warning Letters issued during that period to mainstream human drug manufacturers for cGMP violations (excluding compounding pharmacies), 30 were for facilities outside the United States and 22 were for data integrity/data integrity protection issues. We haven’t performed a detailed analysis of Warning Letters posted in the last four months, but a quick review shows that the trend continues.
Reasons that there have been so many Warning Letters in this area include the increased number of foreign inspections, and the increasing specialization of the investigators performing these inspections. One of the investigators who identified many of the deficiencies leading to the Warning Letters is Peter Baker, who is stationed in India, but has also performed inspections in China. To his credit, Mr. Baker has proven to be especially gifted at tracking down laboratory testing (usually performed on High Performance Liquid Chromatography equipment, or moisture analysis equipment) that has not been properly analyzed, documented, or reported by laboratory personnel. Another trend is that microbiological and sterile technique experts are being sent to inspect aseptic processing areas, enforcing very strict – some would say unreasonably strict – standards in sterile manufacturing technique, or environmental or personnel monitoring.
Such specialized investigators may be more adept and knowledgeable at identifying issues, making for undoubtedly “smoother inspections” instead of flailing around. But just because an inspection may be smoother, it does not mean that there will be happier consequences for the affected facilities.
What’s a pharmaceutical manufacturer to do? Ensure that all electronic testing equipment is Part 11 compliant, and perform regular audits of electronic data to make sure that testing is not being hidden, that data are not being destroyed, and that laboratory and manufacturing personnel are strictly following Good Documentation Practices. Also, watch Warning Letters for trends in cited deficiencies, and do everything possible to ensure that when specialized investigators show up to perform an inspection, you are confident that you know what they will find.
As the experience of many companies has demonstrated, the expenditures required to identify and correct problems in advance of an FDA inspection are only a fraction of what is required if the specialized investigators identify the problem for you, and FDA imposes serious sanctions, such as import alerts.
Industry newsletter The Pink Sheet reports that, at a conference Monday, FDA said that investigators performing FDA inspections will likely be divided into “subspecialties within the various product groups.” Thanks for reporting that news, but we are not sure we agree with The Pink Sheet prediction that this development “surely will be welcomed by industry, because it could lead to smoother inspections.”
Notably, the announcement was made by FDA’s GDUFA (Generic Drug User Fee Act) staff director for the Office of Regulatory Affairs at FDA. She has been a very busy woman: the number of Warning Letters issued to drug manufacturers has mushroomed in recent years, and most of those letters have been issued to foreign generic drug manufacturers, or to the facilities that manufacture Active Pharmaceutical Ingredients (many of which are used in generic drug manufacturing). Indeed, we reviewed Warning Letters issued by FDA between July 1, 2013, and May 26, 2015, and of the 35 Warning Letters issued during that period to mainstream human drug manufacturers for cGMP violations (excluding compounding pharmacies), 30 were for facilities outside the United States and 22 were for data integrity/data integrity protection issues. We haven’t performed a detailed analysis of Warning Letters posted in the last four months, but a quick review shows that the trend continues.
Reasons that there have been so many Warning Letters in this area include the increased number of foreign inspections, and the increasing specialization of the investigators performing these inspections. One of the investigators who identified many of the deficiencies leading to the Warning Letters is Peter Baker, who is stationed in India, but has also performed inspections in China. To his credit, Mr. Baker has proven to be especially gifted at tracking down laboratory testing (usually performed on High Performance Liquid Chromatography equipment, or moisture analysis equipment) that has not been properly analyzed, documented, or reported by laboratory personnel. Another trend is that microbiological and sterile technique experts are being sent to inspect aseptic processing areas, enforcing very strict – some would say unreasonably strict – standards in sterile manufacturing technique, or environmental or personnel monitoring.
Such specialized investigators may be more adept and knowledgeable at identifying issues, making for undoubtedly “smoother inspections” instead of flailing around. But just because an inspection may be smoother, it does not mean that there will be happier consequences for the affected facilities.
What’s a pharmaceutical manufacturer to do? Ensure that all electronic testing equipment is Part 11 compliant, and perform regular audits of electronic data to make sure that testing is not being hidden, that data are not being destroyed, and that laboratory and manufacturing personnel are strictly following Good Documentation Practices. Also, watch Warning Letters for trends in cited deficiencies, and do everything possible to ensure that when specialized investigators show up to perform an inspection, you are confident that you know what they will find.
As the experience of many companies has demonstrated, the expenditures required to identify and correct problems in advance of an FDA inspection are only a fraction of what is required if the specialized investigators identify the problem for you, and FDA imposes serious sanctions, such as import alerts.
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