FDA Increased GMP Audits of Generic Drug Facilities by 60%
In a recently published report from the Office of the Inspector General (OIG), in the last 2 years, FDA has increased GMP inspections of generic drug manufactures by almost two-thirds. About 90% of these inspections were surveillance inspections in which FDA randomly inspected facilities for compliance with GMP. FDA focused its inspections on “high risk” sites and increased its audits of non-US locations. The US and non-US sites were equally likely to get audited with about 50-50 split between the US and non-US audits. Still FDA could not complete all pre-approval audits requested by the Office of Generic Drugs leading to delays in approval of new generic drugs. About half of FDA audits ended with major findings that either led the manufacturer to voluntarily take corrective actions or the manufacturer being classified unacceptable by FDA. In the coming year, FDA promised to conduct more GMP audits to cover maximum number of manufacturing sites. It also plans to further enforce the facility registration with FDA and the request manufacturers to submit additional documents prior to the GMP audits to facility a more thorough and quicker audit. [Learn about FDA’s GMP regulations; Learn about how to withstand an FDA audit; Learn how to do meetings with FDA to seek advice on compliance issues]
Article Source:
OIG report
The Wall Street Journal
Our regulatory expert shares his thoughts below.
In a recently published report from the Office of the Inspector General (OIG), in the last 2 years, FDA has increased GMP inspections of generic drug manufactures by almost two-thirds. About 90% of these inspections were surveillance inspections in which FDA randomly inspected facilities for compliance with GMP. FDA focused its inspections on “high risk” sites and increased its audits of non-US locations. The US and non-US sites were equally likely to get audited with about 50-50 split between the US and non-US audits. Still FDA could not complete all pre-approval audits requested by the Office of Generic Drugs leading to delays in approval of new generic drugs. About half of FDA audits ended with major findings that either led the manufacturer to voluntarily take corrective actions or the manufacturer being classified unacceptable by FDA. In the coming year, FDA promised to conduct more GMP audits to cover maximum number of manufacturing sites. It also plans to further enforce the facility registration with FDA and the request manufacturers to submit additional documents prior to the GMP audits to facility a more thorough and quicker audit. [Learn about FDA’s GMP regulations; Learn about how to withstand an FDA audit; Learn how to do meetings with FDA to seek advice on compliance issues]
Article Source:
OIG report
The Wall Street Journal
Our regulatory expert shares his thoughts below.
