the future of pharmaceutical inspections no deviation

The Future of Pharmaceutical Inspections

At the recently held ISPE Singapore Affiliate Conference & Exhibition 2022, Dr Joey Gouws, the Team Lead of Inspections of the World Health Organization Prequalification Programme shared 3 of WHOs activities, which you may have read about in our previous article.  

In this article, we share the panel discussion at the ASEAN Regulatory Roundtable: The Future of Pharmaceutical Inspections, which was moderated by Bob Tribe, Asia Pacific Regulatory Affairs Advisor, ISPE, Australia. This event followed the talk by Dr Joey at the conference. 

The panellists were: 

Dr Joey Gouws, Team Lead of Inspections, PQ Programme from WHO, Switzerland, 

Sia Chong Hock, Director (Quality Assurance) & Senior Consultant (Audit & Licensing), Health Products Regulation Group, Health Sciences Authority (HSA), Singapore, and 

Mohd Nasrul bin Mohamad Noor, GMP Section Centre for Compliance & Quality Control, National Pharmaceutical Regulatory Agency (NPRA), Malaysia 

The panellists were asked to share their opinions on certain questions that were raised. Below are the questions and answers from the conference: 

Q: Due to the Covid situation, the way Regulatory Authorities have carried out inspections has changed. Some inspections were carried out remotely (termed distant inspection). Will this form of inspection continue, or will the inspection be a hybrid form, where it consists of both remote and on-site inspections? 

According to Dr Joey, a fully virtual or remote inspection will never be able to replace an onsite inspection. There are just too many variables that onsite inspection will be able to identify, which is not possible for a virtual inspection. She also thinks that the number of hybrid inspections will grow in the future. Taking the verification of CAPAs as an example, instead of going back on site to verify that the CAPA is performed, the inspectors can perform a remote inspection, since they already have knowledge of the facility’s layout after the onsite inspection. She expects that there will be more hybrid inspections for CAPA reviews, as it is much easier using this method to follow up on the CAPA implementation. However, hybrid inspections are not so suitable, especially in the case when a new facility, a new technology or a product is being introduced. 

Sia shared the same thoughts as Dr Joey. When talking to fellow inspectors from HSA, as well as inspectors outside of Singapore, most, if not all, still think that the onsite inspection is the gold standard. However, there are still some challenges regarding the choice of platforms being used for remote inspection, such as MS teams, and Zoom. While performing remote inspection, internet connectivity, microphones and web cameras have all presented some issues. In addition, there could also be time zone differences. The lack of language and facial expressions from the hosts also make the inspections challenging. There are also difficulties when inspecting cleanrooms, HVAC and computerized systems, as with remote inspection, not all areas can be seen via the web cameras or be presented by the hosts. However, there are also advantages to remote/ hybrid inspection. It helps to cut down on travel time, thus saving costs. Less time is spent on-site for inspection. This gives some degree of flexibility, for example, a usual 5-day onsite inspection can be split into 2 days onsite and 2 days remote with even a break in between. And, within even a single day, it can split into having onsite inspection in the morning, and remote inspection in the afternoon. Sia does think that the future of hybrid inspection is very bright. 

As for Nasrul, he shares the same sentiments as the other two panellists. Currently, NPRA is still exploring the possibility of hybrid inspection or remote inspection for future inspections. As of now, NRPA has resumed the full onsite inspection and he feels that full onsite inspection is still the best. 

Dr Joey also shared that during the WHO inspection process, WHO usually takes along an NRA inspector for the inspection. This can be considered as a hybrid inspection as well, such that when the WHO inspector returns to their country, WHO can call on the NRA inspector who is in the country to help verify that the CAPA has been implemented since the site will be under their responsibility. In bringing the NRA inspector with them, the NRA inspectors get to learn from and participate in the initial inspection. 

Finally, Sia shared that remote inspection has played an important role during the Covid period, as it has led to business continuity. Without remote inspection and the use of international reliance, most businesses would not have continued. 

Q: Reliance and collaboration have become more important for regulators around the world. There are a number of initiatives with regard to reliance and collaboration, and Sia was asked to share about the ACCESS consortium. Dr Joey was asked to share about the EMA inspection sharing initiative. 

As mentioned by Sia, it initially started out as ACSS (Australia, Canada, Switzerland, Singapore) consortium. Following UK Brexit, the UK joined ACSS. It was then renamed as ACCESS consortium, where the 5 members are Health Canada (HC), the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom, the Swiss Agency for Therapeutic Products (Swissmedic), and the Therapeutic Goods Administration (TGA) of Australia. This collaboration has led to faster access to a new therapeutic product, Vabysmo® (faricimab), for the treatment of two eye diseases that are leading causes of irreversible vision loss. The review involved a five-way product evaluation that was accomplished through the Access Consortium’s “New Active Substance Work Sharing Initiative” (NASWSI) for the first time. This multi-agency initiative aims to expedite patients’ accessibility to novel medicines and treatment by enhancing the efficiency of the regulatory review process and reducing duplication of efforts for both the regulators and the pharmaceutical company. Through NASWSI, the company submitted the product application to the five agencies at the same time. The review work was divided among the five regulators to assess the safety, quality and efficacy of the therapeutic product, with each assessment further peer-reviewed by the regulators. The company then received a consolidated set of review questions from the Consortium, instead of having to address multiple sets of questions, had it filed separate applications with each regulator in each country. After the coordinated review, each regulator then made an independent decision on whether to authorize the therapeutic product for their country. 

Dr Joey mentioned that WHO has been sitting in quite a number of collaboration meetings. One of the most important ones was the rationalization of GMP inspections, consisting of EMA, TGA, Health Canada, and FDA. This is a monthly meeting where the GMP status of a specific manufacturing facility is being looked at. They look at where and when the inspection is going to take place, and then try to combine resources for these inspections. This is performed by either tapping into the inspection pool of the country, or by trying to combine and form the inspection team to go to the facility. 

Q: To share more regarding the new initiative that started on hybrid inspection. 

Sia shared that ICMRA has carried out a pilot study for collaborative hybrid inspection. This is done via a combination of an on-site inspectorate (by one NRA) and remote inspectorate (by at least one NRA) connecting at the same time to the ongoing activities at the facility using virtual technology. The Collaborative Hybrid Inspection Pilot aspires to conduct 3-5 inspections to support the scope and objectives. After the conclusion of the pilot programme, an assessment will be performed and a report with conclusions and recommendations will be published accordingly. 

Q: What are some of the inspection tools for the future? 

Dr Joey shared that WHO has been contacted by Melinda Gates to provide HoloLens for the inspector, where what the inspector sees gets projected back into Teams. However, this is still a pilot stage where there is still work to be done. 

Nasrul shared that as inspectors, they have to adapt to what is available for inspection. Stabilizing tools could be used to aid video inspection. 

Sia shared that HSA has not yet gone into using HoloLens, robotics, and wearable cameras. 

Q: There are sophisticated technologies being used in the manufacturing of pharmaceuticals, and thus the need for GMP inspectors to have good technical knowledge and good technical support. We are seeing more and more inspections using technical specialists, microbiologists, and chemists for their inspections. Are we going to see more of this in the future? 

According to Dr Joey, WHO normally takes an expert with them, depending on the specific activity or facility that they inspect. For example, if the inspection is for an API facility, WHO will take an API specialist. The specialist is normally part of the assessment team of the dossier. She believes that as technology develops, it is not possible for an inspector to have the knowledge of all the technologies and thus will need to take experts with them for inspections. She thinks the industry can help with the development of specific inspection teams where the inspectors can be exposed to the newer technologies and learn about them. 

Nasrul mentioned that at this moment, the NPRA have their own quality control expert joining their inspection. However, there could be the possibility of inviting the drug assessor to join the inspection in the future if there is a need. He shared that whoever joins the inspection team should have a clear role and function to allow them to focus and participate in the inspection. 

According to Sia, HSA has an internal inspection procedure that allows them to incorporate external or technical specialists into the inspection team. For example, they have used product assessors when they perform inspections for parametric release. They have also used HPLC specialists and analysts from HSA internal laboratories. If there is any expertise that they do not have, they can draw from academia as well. They have, in fact, engaged the help of microbiologists and virologists from academia before. They have also made use of technical expertise from another regulatory authority, Swissmedic. This has happened as HSA has a blood bank which has a cell processing laboratory, and to have their own team perform the inspection would amount to a conflict of interest. 

We hope you will have benefited from the insights and opinions of these experts in the field on the future of pharmaceutical inspections. 

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