The ISPE Singapore Conference and Exhibition was held virtually on 9 to 11 December 2020. This year also marks the 20th anniversary of the ISPE Singapore Affiliate. Highlights from the conference included developments in regulations and guidelines for the pharmaceutical industry and how ISPE adapted to COVID-19.
The pharmaceutical industry was one to watch in 2020, as the world recognised the importance of drug research and development during the COVID-19 pandemic. Recent technological developments in biomanufacturing methods and equipment have also provided a boost to the biopharmaceutical industry, allowing it to grow almost exponentially in the past few years. Along with the rapid growth of the industry comes a need for proper regulations.
The International Society for Pharmaceutical Engineering (ISPE) is one of the most well-known non-profit associations worldwide specialising in scientific, technical, and regulatory advancement from the start to the end of pharmaceutical manufacturing processes. Besides making sure that countries and industries follow regulations to ensure the safety of their workflows and products, ISPE also trains future inspectors, and adapts its regulations based on how the pharmaceutical industry progresses over time, for instance through Pharma 4.0 and ICH Q10 (Pharmaceutical Quality System) guidelines, as well as Chemistry, Manufacturing, and Control (CMC) and Good Manufacturing Practices (GMP) in general.
Like most conferences held in 2020, the annual ISPE Singapore Conference and Exhibition went completely digital. It was organised by the ISPE Singapore Affiliate, which was established in June 2000, making 2020 the year where the Singapore Affiliate commemorated its 20th anniversary.
Pharma 4.0, which stems from Industry 4.0 guidelines, was specially adapted by ISPE for evaluation of companies in the pharmaceutical industry. It incorporates elements of ICH Q10, and aims to give consideration to automation and digitalisation. Pharma 4.0 will strive for high levels of transparency and adaptivity, and evaluates companies’ performances based on their resources (including digitalisation and the workforce), information systems (such as the management of a holistic value network, and integration and traceability), organisation and processes (through evaluating the ICH holistic control strategy and life cycle management), and culture (including communication skills and decision making). Using Pharma 4.0, evaluators study companies’ performance through the aforementioned factors in a bid to adapt to new challenges and increasing digitalisation in the pharmaceutical industry.
The ICH Q12 guidelines were also mentioned at the conference. The ICH quality guidelines, which range from ICH Q1 to Q12, aim to achieve harmonisation in pharmaceutical quality, based on GMP risk management. ICH Q12 is a new guideline currently in Step 5 of the ICH process, also known as the implementation step. It focuses on lifecycle management, particularly in the biopharmaceutical sector, and is meant to complement other ICH guidelines, from Q8 to Q11. Considerations for ICH Q12 consist of innovation and improvements, quality assurance, and proactive planning of supply chain adjustments in the biopharmaceutical industry. During a panel discussion at the conference, it was suggested that ICH Q12 leverages on companies’ knowledge and familiarity with their own products to drive innovation. ICH Q12 is in the process of implementation in China, Chinese Taipei, Europe, and the United States, and could be implemented in many other countries in the near future.
Besides regulatory guidelines, another key topic discussed over several presentations during the conference was how the COVID-19 pandemic had an impact on regulatory practices. In Singapore, the pharmaceutical industry is a significant contributor to the economy, and we export more pharmaceutical products than we import. When the country went into its circuit breaker phase, it became near impossible for physical site inspections to be conducted locally and overseas, causing pharmaceutical manufacturing activities to slow down.
Apart from the economic impact caused by reductions in physical site inspections, another pressing issue at the time was the research and production of medication and potential vaccine candidates for COVID-19. Without inspections and regulatory approval, manufacturers are unable to synthesise and sell their pharmaceutical products, which could result in drug shortages and delay in vaccine production.
In an attempt to address this concern, ISPE employed remote inspections more frequently, also referred to as desktop inspections. However, conducting remote inspections requires a lot of planning and consideration, since the essential documents need to be transferred online, and companies need to be able to show inspectors around their facilities so that a fair assessment can be made. On a positive note, remote inspections allowed inspectors in Singapore to conduct asessments of overseas sites without having to travel, which remains difficult even now as COVID-19 continues to affect many countries. Furthermore, remote inspections offer more flexibility to inspectors and companies alike. Moving forward, ISPE might be considering a combination of remote and onsite inspections, which would likely be the best of both worlds for all parties involved.
The conference speakers also provided some insight into some upcoming trends in pharmaceutical regulation in various countries. In particular, regulatory changes in the United Kingdom (UK) post-Brexit were presented, which may be of interest to companies looking to sell their products in the UK. Under post-Brexit circumstances, Northern Ireland experiences different regulations as compared to other regions in the UK, namely England, Scotland and Wales. This is mainly due to Northern Ireland having a protocol that enables an open border between Ireland and Northern Ireland, while maintaining the integrity of the UK market. Therefore, Northern Ireland will continue to have access to markets within the European Union (EU). Details on specific policies can be found from the website of the Medicines & Healthcare Products Regulatory Agency in the UK.
The ISPE Singapore Conference and Exhibition 2020 provided a glimpse of the work undertaken by regulatory authorities and companies in the process of pharmaceutical development and production. The efforts of the various parties to ensure that regulatory practices are harmonised across different organisations and countries, so as to provide consumers with safe and effective products, can be observed from the considerations put into establishing new regulations and adapting current ones to keep up with innovation and technological advancement. [APBN]