Indian pharma sees USFDA norms for manufacture & inspections during the pandemic phase as appropriate when virtual audits take centre-stage. The global regulatory has now issued a guidance on the manufacture, supply chain and inspections of drugs and biological during the C-19 pandemic.
The guidance is being implemented immediately, and the regulator is determined that prior public participation for this guidance is not feasible during this public health emergency situation.
It was only from July 20, 2020, USFDA resumed prioritized domestic inspections and prepared for resumption of local inspections with new risk assessment system.
Those for foreign pre-approval, surveillance, and for-cause inspections that are not deemed mission-critical still remain temporarily postponed. Inspections that can be conducted are also limited due to travel restrictions.
In the case of India which accounts for the highest USFDA facilities outside the US, the global regulator intends to adopt alternative tools, when appropriate, to evaluate facilities.
This includes requesting existing inspection reports from its regulatory counterpart through mutual recognition agreements and other confidentiality agreements.
Request for information are made to applicants, for records and other information directly from facilities and other inspected entities, to conduct remote interactive evaluations where appropriate.
The guidance provides clear cut steps on the modes of seeking approvals of the products, said a section of Indian pharma companies. They noted that the guidance are suitable in the current scenario where remote surveillance facility inspection is the focus.
The regulator focuses on how to implement manufacturing process and facility changes. It also indicated the process for reporting changes to an application. “As this situation remains an evolving and very dynamic one, we will continue to be flexible and as transparent as possible,’ stated the regulatory note.
With regard to inspections, the regulatory authority said that inspections are impacted by C-19. During this phase it has continued, on a case-by-case basis, to conduct mission-critical inspections and other activities to ensure that FDA-regulated pharmaceutical products are meeting applicable requirements.
In the beginning of the C-19 pandemic, USFDA said it was temporarily postponing all domestic and foreign routine surveillance facility inspections. Similarly, routine surveillance inspections in support of the Bioresearch Monitoring (BIMO) programme were postponed.
The types of inspections deemed as mission-critical for USFDA are related to the public health benefit of patients. These factors include whether the product is breakthrough therapy, orphan-drug, or regenerative medicine advanced therapy.
It will also cover those included in the drug shortage or CBER-Regulated Products Shortage list used for critical care for a serious disease including C-19, for which there is no other appropriate and available treatment.
When determining whether to conduct a mission-critical inspection, FDA also takes into account concerns about the safety of its investigators, employees at a site or facility, and where applicable, clinical trial participants and other patients at investigator sites.
For the foreseeable future, prioritized domestic inspections will be pre-announced to FDA-regulated businesses. This helps ensure the safety of the investigator and the firm’s employees, providing the safest possible environment to accomplish its regulatory activities, while also ensuring the appropriate staff are on-site to assist.
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