Malaysia Swaps On-Site GMP Checks For Virtual Inspections At Foreign Sites
Executive Summary
The COVID-19 pandemic has driven the Malaysian National Pharmaceutical Regulatory Agency to explore new mechanisms to oversee compliance with good manufacturing practice requirements at foreign and domestic sites.
Malaysia’s medicines regulator has announced plans to commence remote inspections of foreign drug manufacturers from 1 September, as a temporary replacement for on-site inspections that continue to be on hold due to ongoing COVID-19-related travel restrictions and border closures.
The National Pharmaceutical Regulatory Agency (NPRA) explained that since the start of the pandemic, it has relied on “other pathways” to check compliance with good manufacturing practice (GMP) requirements at foreign sites to support the registration/renewal of medicinal products.
These include asking companies to submit additional information and relying on inspection reports issued by other competent authorities. From September, the NPRA will commence remote inspections, also called distant assessments, of foreign sites “to replace on-site foreign GMP inspection.”
Remote inspections, it explained, include documentation review followed by a virtual inspection that utilizes technologies such as live or real-time streaming video, screen-sharing or other means of real-time communication. It may also include a “virtual tour” of certain aspects of the manufacturing site, video communication and interviews.
If the outcome of the remote inspection is found acceptable, the company can apply for a GMP certificate for the foreign manufacturer. The certificate will clearly specify that the site underwent a remote inspection. The validity of GMP certificates issued following a remote inspection will be two years, as opposed to three years for inspections conducted on site.
“The certificate shall be used administratively for product registration/re-registration/change of manufacturing site purposes with NPRA,” the agency said in an updated GMP guideline that will apply from 1 September.
Remote Inspections Vs Desktop Assessments
The NPRA clarified that remote inspections were a temporary arrangement for foreign sites and that “on-site foreign GMP inspection will resume” when the COVID-19 pandemic subsides. It also stressed that the provision for remote inspections was only available to those foreign sites for which an on-site inspection was pending.
This means that foreign manufacturers that are eligible for the NPRA’s existing provision of GMP Desktop Assessment (GDA) work process are excluded from remote inspections. The NPRA rolled out desktop assessments for foreign drug manufacturers in April 2021 to allow them to extend the status of their existing GMP certificates so as to facilitate the registration and/or renewal of medicinal products in Malaysia.
The desktop assessments are meant for foreign manufacturers that have been previously inspected by the NPRA and have a valid GMP status. Following a satisfactory desktop assessment, the validity of the site’s GMP status is extended for two years. A foreign manufacturer can apply for a desktop assessment for a maximum of two consecutive times.
Improved Off-Site Measures For Domestic Sites
For domestic manufacturing sites, the NPRA has already conducted some remote inspections and desktop assessments. To improve its existing off-site inspection mechanisms, the agency is rolling out “hybrid inspections” along with remote inspections from 1 September for domestic drug manufacturers.
Hybrid inspections include documentation review followed by an on-site inspection. Under this approach, as most documents are reviewed earlier on, the time spent at an on-site inspection can be shortened compared with the usual approach to on-site inspections, the agency explained.
The NPRA has issued an FAQ document explaining the steps that companies and inspectors can take to minimize the risk of COVID-19 infection to all parties in the context of a hybrid inspection. The validity of GMP certificates issued following a hybrid inspection will be three years, the agency added.