Issue link: https://www.e-digitaleditions.com/i/1035980
Tablets & Capsules October 2018 15 has signed MRAs with EU countries found capable, and plans to sign more in the future. This reduces the number of on-site current good manufacturing practice (cGMP) inspections FDA personnel must perform, though the agency does retain the right to perform on-site cGMP inspections if deemed necessary. The FDA monitors the quality of drug products in the US supply chain using the MedWatch program, the NDA/ANDA reporting program, and the DQST pro- gram. The agency may perform on-site cGMP inspec- tions in MRA countries when information from these programs indicates a drug product quality problem. Foreign manufacturers should consider the risks associ- ated with an FDA on-site directed cGMP inspection, which could result in discontinuation of the MRA and/or the inability of the manufacturer to market drug products in the US. Manufacturers can reduce these risks by hav- ing their manufacturing sites and quality systems periodi- cally inspected by a third-party expert qualified in cGMP for drug products and FDA expectations. For more information on the US-EU MRA, refer to the FDA's Mutual Recognition Agreement landing page [5]. For further MRA-specific inquiries, email FDA- MRA@fda.hhs.gov or contact a reputable consulting firm that specializes in FDA compliance. T&C References 1. https://tinyurl.com/US-EU-MRA-annex 2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfcfr/CFRSearch.cfm?fr=314.81 3. https://www.fda.gov/downloads/drugs/guidances/ ucm070287.pdf 4. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfcfr/CFRSearch.cfm?fr=314.50 5. https://www.fda.gov/internationalprograms/agree ments/ucm598735.htm James Evans is an independent consultant with EAS Consult- ing Group (571 447 5500, www.easconsultinggroup.com). He has more than 35 years of experience as an FDA auditor and specializes in pharmaceuticals, medical devices, biologics, and biotechnology. shall follow the same guidelines for FAR submission, reporting within three working days to the jurisdictional district office where a problem occurred. In the case of an involved foreign facility, the US agent shall submit the FAR to the district office where the US agent is located. Drug quality sampling and testing (DQST) compli- ance program. The goal of the DQST compliance pro- gram is to protect the public health by sampling and test- ing domestic and imported drug products to minimize exposure to noncompliant and/or poor-quality drug prod- ucts. This is accomplished by targeting products (finished dosage forms, APIs, and excipients) for sampling based on risk-based selection criteria and a risk-based model. This program, in combination with other quality-assur- ance compliance programs, is an integral part of the FDA's overall post-marketing surveillance strategy. In previous years, survey samples were typically col- lected directly from manufacturers, distributors, and wholesalers and were primarily prescription drug prod- ucts subject to approved NDAs/ANDAs. Due to the increasing consumer risk caused by globalization of phar- maceutical products, the types of domestic and interna- tional products sampled under this program have expanded to include: • prescription and over-the-counter (OTC) drug products, excipients, and APIs manufactured or repackaged by domestic and international manufac- turers; • drug products available at pharmacy retailers (including compounded drugs); • drug products that have approved NDAs or ANDAs; • unapproved drug products; • APIs considered at risk for economically motivated adulteration; • APIs and excipients considered at risk for melamine and melamine-analog adulteration; and • OTC drug products at risk for diethylene glycol adulteration; • vitamin APIs considered at risk for adulteration. The FDA sample selection includes recommendations from the CDER, the FDA's Office of Regulatory Affairs, and FDA district offices based on their intelligence and reported consumer complaints. The goal is to target those products posing the greatest potential public health risk in terms of quality. The FDA does publish sampling and testing results for drug products included in the DQST compliance pro- gram, and the majority of independently tested products meet their specifications. Between 2003 and 2013, the FDA tested nearly 4,000 samples and found that just 1.1 percent of the drug products analyzed deviated from acceptable standards. Minimizing risks from FDA inspections The FDA has established a process for assessing when another inspectorate is capable of conducting drug manu- facturing facility inspections that meet US requirements,