The European Medicines Agency (EMA) and its counterparts at the European Commission and Heads of Medicines Agencies have updated their questions and answers guidance on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic, adding a new section laying out temporary flexibilities for good manufacturing practice (GMP) and good distribution practice (GDP).
Specifically, the guidance lays out four questions and answers pertaining to GMP flexibilities and three questions and answers on GDP flexibilities, as well as a new section on the suspension of on-site inspections of plasma collection centers.
The new flexibilities are meant “to help manufacturers and distributors of pharmaceutical products to cope with the consequences of the pandemic and ensure availability of medicinal products to respond to increased demand,” the guidance states.
The guidance also encourages member states to implement the new provisions “in order to minimize the disruption of manufacturing and supply of crucial medicines in [the European Economic Area].”
GMP flexibilities
According to the guidance, it is possible for companies to rely on limited prospective qualification to introduce new premises and/or equipment to ensure the continuous availability of medicines needed to treat COVID-19.
To do so, the guidance says that companies must use quality risk management principles to “determine the required scope and extent of the limited prospective qualification” and that additional risk mitigation measures should be adopted. Any decisions should be documented within the pharmaceutical quality system (PQS) and be cleared by the authorized personnel. Regular qualification must be resumed “as soon as COVID-19 restrictions are lifted.”
The guidance also allows for concurrent validation of manufacturing processes. “For crucial medicines for treatment of COVID_19 patients and where delay in supply may affect those treatments, it is acceptable to conduct process validation concurrently rather than prospectively,” the guidance states.
“Where a concurrent process validation approach is employed, there should be sufficient data to support a conclusion that any given batch of product is uniform and meets the defined acceptance criteria,” the guidance states, noting that processes that assure sterility for sterile products must continue to be prospectively validated.
Companies are also permitted to make temporary changes to certain quality related tasks, “provided that the changes do not adversely impact quality, efficacy and safety of medicinal products manufactured [at] the site.”
This includes deferring certain routine tasks such as maintenance, requalification, revalidation, recalibration, periodic review of PQS documents, on-site re-audits of suppliers, periodic re-trainings and “deferral of stability testing, where justified, to focus resources on product release testing.”
The guidance also provides flexibilities to speed access to imported medicines used to treat patients with COVID-19 to address imminent shortages, including postponing or waiving testing in the third country and postponing certain testing in the EEA.
GDP flexibilities
The guidance also explains temporary flexibilities for GDP during the pandemic related to the duties of the responsible person (RP), the use of new equipment or newly authorized premises for storage and distribution and deviations from normal practice.
According to the guidance, RPs may work remotely during the pandemic only if the “regional or national government authority has implemented quarantine measures such as stay-at-home restrictions for entire regions or the whole country resulting in cancellation or prohibition of travelling.”
The guidance also allows for the potential for RP duties to be delegated under limited circumstances.
Additionally, the guidance explains that “new equipment or re-purposed equipment may be used with limited prospective qualification to allow it to be used as soon as possible” to distribute medicines.
“Where prospective validation has been limited for premises and equipment used for the storage and distribution of medicines then this should be compensated by employing sufficient ongoing monitoring such that there is evidence that medicines are stored and transported under the required conditions,” the guidance states.
Lastly, the guidance permits certain deviations from normal practice during the pandemic, including changes related to documentation, audits, non-conformity and corrective and preventative action (CAPA) management and training.
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