Glr study | Science homework help

1. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).

Your quality unit (QU) lacks appropriate responsibility and control over your drug manufacturing operations. During the inspection, our investigator observed discarded CGMP documents and evidence of uncontrolled shredding of documents. For example, multiple bags of uncontrolled CGMP documents with color coding indicating they were from drug production, quality, and laboratory operations were awaiting shredding. Our investigator also found a blue binder containing CGMP records, including batch records for U.S. drug products, discarded with other records in a 55-gallon drum in your scrap yard. CGMP documents in the binder were dated as recently as January 21, 2019: seven days before our inspection. Your QU did not review or check these documents prior to disposal. Your QU is responsible for the oversight of your drug manufacturing operations, including the review and approval of documents and document controls, to ensure a complete contemporaneous record of each batch of drug product manufactured. That record is retained for CGMP purposes including annual review. In addition, your QU is responsible for ensuring your production areas are adequately monitored and that employees understand your firm’s procedures and their assigned tasks. The uncontrolled destruction of CGMP records, and your lack of adequate documentation practices, raise questions about the effectiveness of your QU and the integrity and accuracy of your CGMP records. In your response you state the binder of CGMP documents in your scrap yard was “inadvertently come [sic] to scrap yard” and that you were investigating the issue. You also committed to using bound log books and restricting printing to reduce uncontrolled documents. In addition, you committed to strengthen your training program to include instructor-led classes geared towards good documentation practices. 1/12/2020 Strides Pharma Science Limited - 576722 - 07/01/2019 | FDA https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-07012019 3/5 Your response is inadequate because, while you acknowledge the binder of CGMP records in your scrap yard, you did not assess other documents found in the scrapyard, nor did you assess how poor documentation practices affected distributed drug product or how you would strengthen your QU oversight. Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download (h�ps://www.fda.gov/media/71023/download%0d)