Drugmakers get return-to-normal guidance from FDA

Regulatory NewsRegulatory News | 11 September 2020 |  By 

A new temporary guidance for drug and biologics manufacturers from the US Food and Drug Administration (FDA) details recommendations for returning to normal production operations during the public health emergency of the COVID-19 pandemic.
“This guidance provides recommendations to help manufacturers prioritize products as they resume normal operations and as they remediate current good manufacturing practice (CGMP) activities that were necessarily delayed, reduced, or otherwise modified during the public health emergency in order to maintain production and the drug supply,” said FDA in announcing the availability of the temporary guidance.
The guidance also points to procedural guidance made final in 2011. Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products, said FDA, already provided a high-level view of steps to be taken during an emergency such as a pandemic, but the new temporary guidance gives more detail and is specific to the COVID-19 public health emergency.
Manufacturers of drugs and biologics whose production activities deviated from CGMP during the pandemic to date should include an assessment of those actions as part of their risk management approach, according to the guidance. Manufacturers should give highest priority to those drugs or biologics that are in shortage, or that might be vulnerable to shortage.
The guidance includes all drugs and biologics, but the risk of shortages of some categories of medically necessary drugs, says FDA, “is an important consideration when determining whether certain manufacturing and quality assurance activities may be reduced in frequency, delayed, or handled differently than prescribed in established procedures.”
Remediation may not be possible in some cases until after the public health emergency ends, acknowledges the agency. However, when critical CGMP activities were disrupted or halted, affected batches should still be quarantined until after remediation activities that assure drug quality can be completed. The guidance reminds drug manufacturers that the hunt for areas that might need remediation extends beyond their own facility; external services, excipients and other materials may also have been affected in a manner that needs remediation. The guidance lays out specific considerations and questions for suppliers.
The guidance provides manufacturers with specific areas where FDA judges that remediation may be needed, along with a series of questions for each area that serve as prompts for ascertaining the need for remediation and type of remediation required.
Non-critical product or process discrepancies or deviations that were identified before the public health emergency of the pandemic and remain unresolved should be addressed, according to the guidance.
When testing was incomplete or potentially inaccurate during the public health emergency, companies should consider what the impact of delayed or reduced testing that indirectly measures a batch operation would be on drug quality.
The guidance also provides questions about the specifics of disrupted service to facilities and equipment to guide manufacturers’ decision-making as to whether they should take additional measures.
Finally, the guidance encourages manufacturers to formulate a comprehensive plan to resume normal operations, even if they are not yet able to do so. “Drug manufacturers who have not established a resumption plan prior to this public health emergency may find themselves in the suboptimal position of having to quickly develop and execute a plan at the same time; this can lead to errors and poor decisions,” notes FDA.
A resumption plan should include a risk management approach that encompasses all factors that might affect product quality, with a specific timeline and a plan for review by the manufacturer’s quality unit. The plan should also detail all required reporting, including the need for recall. The plan should be flexible enough to accommodate changes in priorities as new information emerges.


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