Interruptions to the inspection programme of the European Directorate for the Quality of Medicines & HealthCare (EDQM) due to travel restrictions – made necessary by the COVID-19 pandemic – led to the creation of a system of Real-Time Remote Inspections (RTEMIS). This pilot project combines a live video feed, linking inspectors and manufacturing sites of active pharmaceutical ingredients (APIs), and the review of documentary sources, with the objective of monitoring compliance with both Good Manufacturing Practice (GMP) and applications for Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) in manufacturing sites.
The EDQM inspection programme is an integral part of the CEP procedure and is therefore essential to ensuring the availability of good quality medicines. Because the vast majority of inspections takes place in India and China, the EDQM had to find new ways to continue the GMP evaluation of manufacturing sites, complementing the traditional combination of on-site inspections and documentation-based assessment of companies.
Technical and administrative solutions meeting strict requirements in terms of information confidentiality and security, inspector safety and of course the effectiveness of the site inspection procedure itself were first examined in detail during a feasibility study, then put into practice in a pilot phase with several manufacturing sites in India.
These sites, selected on the basis of their GMP-compliance history and a risk assessment, were invited to participate on a voluntary basis.
The objectives of these initial inspections were achieved: a number of minor and major deficiencies were observed and the Corrective and Preventative Action Plans the companies put in place led to a satisfactory degree in GMP conformity on the remotely inspected sites.
Circumstances and safeguards appropriate for real-time remote inspections are being further examined, but the EDQM considers that real-time remote inspections could be fully integrated into its inspection programme in the future. While this approach cannot replace on-site inspections in terms of value and effectiveness, it does enable inspectors to assess GMP-compliance for companies already having been inspected by the EDQM. Real-time remote inspections could therefore become a third pillar for the supervision of GMP compliance of API manufacturers registered in the EDQM’s CEP scheme.
For more information, see the EDQM’s dedicated web page: “EDQM and real-time remote GMP inspections of API manufacturers during the COVID-19 pandemic: innovation overcoming adversity
The United States has been pushing India to restart vaccine exports as it looks to stem the global spread of the Covid pandemic.
Quess Corp, India’s leading business services provider, announced the launch of its new healthcare vertical to address the shortage of healthcare professionals.
The shippers are in for struggle yet another time, with the market buzzing in speculations of liners planning of ‘blank sailing’ during China’s Golden Week holiday in early October to extract maximised profits.
Less than a month into a COVID-19 vaccine booster drive, Israel is seeing signs of an impact on the country’s high infection and severe illness rates fuelled by the fast-spreading delta variant, officials and scientists say.
Researchers have developed a blood test able to detect more than 50 types of cancer that is accurate enough to be used nationally as a multi-cancer screening test in those at higher risk of the disease, including those aged over 50 with no symptoms.
At Last: Separated and Freshly Bound –
Amidation of light alkanes
AstraZeneca (AZ) has announced that new real-world data from Canada shows its COVID-19 vaccine – Vaxzevria – was found to be highly effective after one dose against severe disease or hospitalisation caused by the Beta and Delta variants.
A number of recent events such as a new worldwide wave of COVID-19, natural disasters in China and Germany, a cyber attack targeting key South African ports have conspired to drive global supply chains towards breaking point, threatening the fragile flow of raw materials, parts and consumer goods, according to companies, economists and shipping specialists.