Pharmaceutical Technology - December 2019

Pharmaceutical Technology - Regulatory Sourcebook

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Page 4 of 43

Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 5 A recent warning letter illustrates how an inad- equate response to violations can create additional problems for a drug company. Mylan Laborato- ries received a warning letter in November 2019 for failing to have adequate written procedures for the receipt, identification, testing, and handling of raw materials. Specifically, the citation addressed the company's failure to identify nitrosamine im- purities in solvents used to manufacture valsartan API, which resulted in drug recalls. The company also was cited for inadequate processes for testing and handling of these solvents and the subsequent steps the company took to remedy the problem. In addition, FDA noted that Mylan's cleaning meth- ods for non-dedicated equipment were not ad- equate to prevent contamination or carry-over to other drugs manufactured on that equipment (3). Another letter, to Greenbrier International—the Dollar Tree discount stores—illustrates two points: quality issues by contractors can result in warning letters to the drug license holder, and drug license holders must pay close attention to regulatory en- forcement activity. In a January 2019 inspection, FDA noted that Greenbriar "used contract manufacturers and suppliers with histories of significant drug CGMP [current good manufacturing practice] violations." Some suppliers were placed on import alert, and Greenbriar was sent copies of the warning letters when issued. In addition, FDA noted that Greenbriar required suppliers to use a testing laboratory, Bureau Veritas (BVS), to test products it distributes. BVS repre- sentatives told FDA that BVS's test methods "were not suitable for drug CGMP purposes and that its test results were not suitable to make release deci- sions of drug products for distribution into the US supply chain." FDA reminded Greenbrier that the company was "responsible for ensuring that the drugs you distribute are not adulterated, including ensuring that all drug manufacturers supplying Greenbrier with drugs have had release testing conducted in accordance with CGMP requirements" (4). In this issue The latest installments of the Pharmacopoeia Compliance Series emphasize the need for drug companies to establish formal processes to monitor global and national pharmacopoeia changes to stay informed, and potentially get involved with defin- ing changes in compendial guidelines. Likewise, the quality teams at drug companies and contract service providers should closely monitor regula- tory enforcement activity. FDA's online compli- ance information and Data Dashboard are useful references. Links to other regulatory sources can be found in this ebook on pages 38–43. References 1. FDA, Novel Drug Approvals for 2019,, accessed Dec. 11, 2019. 2. FDA, FDA Data Dashboard, accessed Dec. 11, 2019. 3. FDA, Mylan Laboratories Limited-Unit 8, Warning Letter, Nov. 5, 2019. 4. FDA, Greenbrier International, Inc dba Dollar Tree, Warning Letter, Nov. 6, 2019. PT Effective, ongoing monitoring programs— for regulatory agency enforcement actions and pharmacopoeia updates— are essential for bio/pharma compliance.

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