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Regulatory Focus™ > News Articles > 2020 > 5 > WHO issues guidance for prequalified products amid COVID-19

WHO issues guidance for prequalified products amid COVID-19

Posted 15 May 2020 | By Kari Oakes 

WHO issues guidance for prequalified products amid COVID-19

The World Health Organization (WHO) this month issued guidance detailing its expectations and flexibilities during the coronavirus (COVID-19) pandemic for manufacturers, laboratories and contract research organizations taking part in the agency's prequalifications programs.

Localized adjustments in processes and procedures may be necessary for manufacturing, clinical trial and testing organizations due to the coronavirus pandemic, but should aim to minimize the risk of harms to the product and individuals, according to guidance issued 14 May by the WHO Prequalification Unit – Inspection Team (PQT/INS).
 
Recognizing that the impact of the coronavirus and associated governmental and public health measures vary by country and region, the guidance specifically addresses regulatory expectations and permitted flexibility during the pandemic.

Inspections

WHO PQT/INS will consider waiving or postponing a routine site inspection for organizations that have already been inspected, provided a successful past prequalification inspection has been held.
 
Waiver of onsite inspection for new products under prequalification also will be considered, provided a successful prequalification inspection has occurred. For the addition of a new manufacturing site for a prequalified product, a waiver of onsite inspections may be considered if another regulatory body has performed a successful inspection.
 
If a new organization has a new product under assessment, WHO PQT/INS “may consider waiving an onsite inspection on a case by case basis for high priority medicines, vaccines, medical devices including IVDs, vector control products and related organizations.”
 
Quality Control Laboratory inspections are “not considered a priority during the COVID-19 pandemic,” and postponement may be considered on a case-by-case basis. A desk assessment may also be considered.
 
In all circumstances where a desk assessment may be permitted, WHO PQT/INS notes that onsite inspections may be necessary when travel restrictions are lifted if a desk assessment does not fulfill “the purpose and requirement of the inspection.”

Quality Management Systems

The overarching goal for senior management in organizations is “to ensure the quality, safety, efficacy and continuity in the supply of products and services to meet a high level of public health and protect human lives,” notes WHO PQT/INS. To this end, an effective Quality Management System (QMS) should be in place with sufficient resources for implementation and clear organization-wise communication.
 
Where pandemic impacts are minimal, QMS implementation should continue without adjustments. However, an adjusted QMS may be implemented where COVID-19 and associated restrictions have caused significant disruption. Use risk management principles to guide the identification of hazards and decisions about risk reduction or acceptance of risks, the guidance advises. Clear communication of the plan, ongoing monitoring and detailed recordkeeping are advised. Any deviations from QMS principles should be justified and non-conformance procedures followed.

Personnel considerations

Remote work should be considered and the number of personnel within a facility should be limited where appropriate, the guidance advises. All modifications “should be justified, documented and monitored.”
 
Organizations should plan for the possibility that employees or research subjects test positive for SARS-CoV-2, the virus that caused COVID-19. The document also recommends other standard public health measures such as providing for temperature checks on work entry, frequent hand washing, training about additional hygiene measures, staying home when sick, and increasing physical distancing. The use of appropriate disposable personal protective equipment (PPE) or decreased duration of use for reusable PPE, as well as keeping visitors and contractors from entering facilities unless necessary, also are addressed.
 
Finally, organizations should develop a transition plan to return to normal operations when the pandemic passes and restrictions are lifted.

Facilities and equipment

Established procedures for cleaning and sanitation should be continued during the pandemic, but agents used and cleaning intervals may need to be adjusted to ensure they are sufficient to combat coronavirus contamination. Also, if any new cleaners or disinfectants are used, they should be assured to have no adverse effects on existing products or services.
 
Air handling by heating, ventilation, and air conditioning systems and in cleanrooms should be evaluated. Increased air turnover rates, enhanced filtration, and increased air pressure can all be considered. Though existing qualification and calibration procedures should be followed, full support of engineering and maintenance may not be possible. If a system's use is continued past a calibration/maintenance due date, the procedure for deviation/non-performance should be followed.
 
Should calibration, maintenance, or qualification of equipment be necessary during the pandemic, consideration should first be given to sending the equipment off-site or achieving the necessary action by remote electronic means. Employees may also be able to use video conferencing to perform calibration or maintenance under the supervision of an off-site contractor.
 
Finally, if two calibrated instruments are in close physical proximity to each other and are measuring the same parameter, “the instrument with valid calibration status may be used to verify the validity of readings of the second instrument that is beyond its calibration due date,” according to the document.

Material

Incoming materials “should be handled carefully to avoid any risk of contamination,” with special attention given to cleaning materials before they are transferred to the warehouse or removed from original packaging. These procedures should not compromise employee safety or material quality. In general, sampling should continue according to approved procedures, with finished products not dispatched until fully tested and released.
 
Tracking and tracing should take into account which personnel were in contact with incoming materials, and which equipment and utilities were used.

Production

Which operations should continue during the pandemic, and which personnel should be on- or off-site, is a decision for senior management, and should be made “taking into account national regulations, guidance and measures” and according to risk management principles. Contract workers should follow the same sanitary and health precautions as employees.

Though extra cleaning and sanitation may be necessary, they should not adversely affect quality. These measures should be documented, as should all other production and packaging activities so that both operations and personnel can be traced.

Quality Control Laboratories

Usual practice should continue in Quality Control Laboratories (QCLs); “the authorized person should continue to ensure completeness of testing before a product is released for sale,” according to the guidance. However, there should be a contingency plan should that person become ill or otherwise be unable to perform these duties.
 
Frequently touched surfaces on computer and laboratory equipment should be cleaned and sanitized often.
 
If skip or reduced testing is considered as part of a science- and risk-based approach, both WHO PQT and the organization’s competent regulatory authorities must first be notified. After assessing supporting documentation, WHO PQT will communicate their decision about whether to permit skip testing.
 
In the particular case of ongoing stability studies, skip or reduced testing can be considered with similar requirements for notification and submission of supporting documentation to WHO PQT and competent regulatory authorities.
 
Though the WHO PQT/INS document may be modified and updated from time to time as global conditions regarding the pandemic evolve, it will remain in effect until further notice from WHO.
 
WHO

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