Issue link: https://www.e-digitaleditions.com/i/1373953
36 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 P h a r mTe c h . c o m therefore, we expect this guidance to either be utilized for, or a similar guidance be authored for, non-COVID-19 products. The pharmaceuti- cal industry tends to not deviate from proven so- lutions, so that approvals or the implementation of post-approval changes are not delayed. Dur- ing this pandemic, industry and FDA had to step outside of their comfort zone and the traditional pathways to find solutions within the existing and new regulatory frameworks. PharmTech: Will FDA's guidance for minimizing the potential transmission of COVID-19 in cell and gene therapies (3) apply to these therapies be- yond COVID-19? Davis-Claeys (Catalent Bloomington): In general, re- spiratory viruses are not known to be transmitted by infusion or transfer of cell and gene therapy products. We would not expect the specific inclu- sion of COVID-19 into the risk assessment for the potential impact on products, facilities, pro- cesses, and manufacturing controls to continue. However, the guidance provided an opportunity for industry and FDA to evaluate their general risk-assessment processes for the potential viral impact on the products, facilities, processes, and manufacturing controls. It would not be unex- pected if additional guidance regarding robust risk assessments is issued. Heidaran (Parexel Consulting): While the guidance specifically provides manufacturers of licensed and investigational cellular therapy and gene ther- apy products with risk-based recommendations to minimize potential transmission of COVID-19, the content is directly applicable to manufacturing of any cell and gene therapy products, which could be impacted by COVID-19 (6). PharmTech: How has FDA's guidance on manu- facturing during the pandemic (7) impacted sterile drug manufacturing and biologics manufacturing, if at all? Heidaran (Parexel Consulting): The guidance docu- ments are not changing the overall applicable regu- lations, but they do provide manufacturers tools to be fully compliant with CGMP [current good man- ufacturing practice] should there be any reported deviations from CGMP during manufacturing of products during this period. [The Resuming Nor- mal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency Guidance for Industry guidance document states,] 'If a drug manufacturer departed from established CGMP activities impacted by the COVID-19 public health emergency, the drug manufacturer should identify these deviations and any necessary remediation actions (see section III(A) below). The drug manufacturer should evaluate these actions as part of their risk management approach (see section III(B)). The results of the evaluation will help the drug manufacturer prioritize resump- tion activities (see section III(C))' (7). Therefore, the strategies used to release the product under emergencies should be reviewed continuously as part of quality management system. Davis-Claeys (Catalent Bloomington): COVID-19 im- pacted many normal activities, such as on-time de- livery of raw materials and components, the ability to audit suppliers, and led to delays in analytical testing. FDA Guidance for Industry, Resuming Nor- Quality/Regulations The COVID-19 pandemic brought on new challenges for the pharmaceutical industry.