由于新冠肺炎疫情，许多制药工厂几年来都没有经历过监管检查。Raj Pai讨论了如何确保良好的生产规范。

Due to COVID-19, many pharmaceutical manufacturing sites have not experienced a regulatory inspection in several years. Raj Pai discusses how to ensure that Good Manufacturing Practices are in place.

在疫情期间，大多数监管机构暂停了对药品生产设施的检查。现在又重启了检查，由于在长期未检查间隙中积累起来很多未被发现的问题，工厂可能会发现自己更容易出现监管问题。当涉及到与公司总部管辖范围不同的工厂时，这可能是一个特殊问题，因为在疫情期间，这些工厂可能会减少监管，同时也损失了有经验的员工和其他资源。

During the pandemic, most regulatory authorities restricted their inspections of pharmaceutical manufacturing facilities. Now that inspections have started up again, sites may find themselves more vulnerable due to undetected issues that have built up in the lengthy gap between inspections. This can be a particular problem when it comes to manufacturing sites that are in a different jurisdiction from corporate headquarters as, during the pandemic, these sites may have experienced reduced oversight, coupled with the loss of experienced staff and other resources.

监管机构承认，由于新冠疫情而导致了检查延误和监管申报资料的审批积压。因此，生命科学公司面临对部分待决申请的工厂进行检查的挑战。

Regulatory agencies have acknowledged that delays in inspections caused by the pandemic have created backlogs with regard to the approval of regulatory submissions. As a consequence, life sciences companies may also face the challenges of inspections at sites that are part of pending applications.

随着监管机构开始处理积压，我们发现一些工厂会被逾期进行监管检查。在此期间，这些工厂仍有机会为下一次检查做准备。准备工作通常包括彻底检查工厂的质量体系。强大的质量体系是良好生产规范（GMP）的核心组成部分，通过建立工艺和规程，在产品放行之前及早发现和解决问题，防止人为造成的错误。公司还要应对维护生产安全、优质产品的弹性系统方面的一系列监管挑战。

As regulators work through the backlog, we are still seeing a number of sites that are overdue for a regulatory inspection. During this time, there is still an opportunity for these sites to prepare for their next inspection. Preparation typically involves thoroughly examining the site’s quality systems. A strong quality system serves as the core building block of good manufacturing practice (GMP) by establishing processes and procedures that guard against human error by detecting and addressing issues early — before product release. Preparation can also mean grappling with the web of regulatory challenges facing life sciences companies when it comes to maintaining resilient systems for the manufacturing of safe, quality products.

公司为即将到来的监管检查做准备的同时，有了一个机会来审查工厂履行供应义务和向市场交付新产品的能力。许多生命科学公司目前正在寻求投资更可靠的采购方案，旨在减少供应链的延伸。这可能意味着他们正在投资改造现有的生产设施或建造最先进的新设施，还可能意味着他们想要通过应用新技术来更新生产工艺，例如，转向连续生产模式，这种空隙为实施和验证新工艺提供了一个及时的好机会。

Preparing for an upcoming regulatory inspection can provide a chance to review the site’s ability to meet supply obligations and to deliver new products to market. Many life sciences companies are currently looking to invest in more reliable sourcing options, with a focus on having less-extended supply chains. This may mean that they are investing in retooling existing manufacturing facilities or in building new state-of-the-art facilities. It could also mean updating manufacturing processes through the application of new technology, such as moving toward a continuous manufacturing model. All of these updates provide an excellent and timely opportunity to implement and validate new processes.

监管逾期也为生命科学公司提供了在检查之前主动与监管机构接触的机会，包括为解决GMP问题和更新工艺而进行的投资。建议公司鼓励监管机构使用疫情期间雇用的人员，并就此进行合作。我们将在以后的博文中将探讨这些技术。

Regulatory changes may also provide life sciences companies with opportunities to engage proactively with regulators in advance of inspections, including emphasizing the investments made to address and update GMP issues and processes. It may be advisable for companies to encourage regulatory agencies to use the employed during the pandemic, and to collaborate on this approach. We will explore these techniques in a future blog post.

随着监管机构开始将一些与新冠病毒无关的问题放在次要位置，工厂应做好准备，重新将重点放在检查上。

Generally, as regulatory agencies move to take a number of non-COVID-related issues off the back burner, sites should prepare for a renewed focus on inspections.