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To support manufacturers during COVID-19, the EMA has updated guidance on the Regulatory expectations for the medicinal products. A new section of temporary flexibilities is added to inputs on good manufacturing practices (GMP), and good distribution practices (GDP). The new development is aimed at responding to the increased demand for medicinal products amid COVID-19. It also encourages Member States to implement new provisions to minimize the disruptions in the manufacturing and supply of crucial medicines in the EEA.
GMP Flexibilities
As per the GMP flexibilities, companies can rely on limited prospective qualification to introduce new premises and/or equipment. In an effort, quality risk management principles must be used to determine the scope and extent of the limited prospective qualification. Also, it is suggested to adopt the additional risk mitigation measures. All the decisions must be documented within the pharmaceutical quality system (PQS) and cleared by authorized personnel. The regular qualification must be resumed after the COVID-19 restrictions are lifted.
As the delay in supply may affect the treatment of COVID-19 patients, concurrent validation of manufacturing processes can be employed for crucial medicines. But there should be adequate data to support that the given batch of products is uniform and meets the defined acceptance criteria. The sterility processes for sterile products must proceed with prospective validation.
Also, the companies are permitted to make temporary changes to certain quality-related tasks such as maintenance, revalidation, requalification, recalibration, on-site re-audits of suppliers, periodic review of PQS documents and periodic re-training, which do not adversely impact the quality, efficacy and safety of medicinal products.
GDP Flexibilities
The updated guidance allows temporary flexibilities for Good Distribution Practices (GDPs) and is related to the - duties of the responsible person (RP), use of new equipment/newly authorized premises for storage and distribution of products.
In this regard, RPs may work remotely if the regional/national government authority has implemented lockdown restrictions resulting in prohibition for traveling. Also, RP duties must be delegated under limited circumstances. Under these flexibilities, certain deviations from normal practice such as changes related to documentation, audits, non-conformity and CAPA management and training are permitted.
To sum up, all the manufacturers and distributors of medicinal products must abide by the new flexibilities of GMPs and GDPs to ensure quick supply of medicines and equipment for the treatment of COVID-19. For comprehensive understanding reach out to a Regulatory expert. Stay informed. Stay safe.
