Submitted by Devendra Mishra, Executive Director, BSMA, 10/08/2020
The belief that necessity is the mother of invention has been reaffirmed with the FDA conducting Virtual Audits of drug manufacturers in a widespread stay-at-home ordinance across the nation. Exacerbated by travel restrictions and hot zones for infections, companies find themselves somewhat paralyzed to carry out the audit mandated by the FDA as well as its own audit of suppliers. The FDA has come to the rescue by allowing digital video and communication technologies to minimize the need for traditional in-person audits. It is still necessary for each organization to ensure that their suppliers continue to provide services and materials that are fit for purpose and in compliance with quality expectations, where the GxP audits are continued to verify that organizations comply with processes and guidelines. As a matter of fact, virtual audits will enhance the traditional audit practices which must be rigid and robust by incorporating significant cost efficiencies.
In March of 2020, the FDA announced it was scaling back foreign and domestic surveillance facility inspections and relying instead upon, among other measures, reviewing records remotely—an authority granted in section 706 of FDASIA amendments of 2012 to the FD&C Act. On July 10th, the agency announced its plan to begin resuming domestic inspections in accordance with a risk assessment during the week of July 20th.
In August 2020 FDA issued a temporary guidance for industry entitled, “Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers.” FDA recognized the COVID-19 public health emergency as not only impacting public health, but also drug development programs, ongoing manufacturing operations, and FDA’s ability to conduct inspections.
Traditional GMP regulations have not expressly prohibited remote auditing, nor did they offer specific guidelines on proper conduct or expectations. Remote auditing consists of multiple phases of planning, document review, process review, facility review, interviews, and closing meetings. In the past, firms determined “the appropriateness and feasibility of a remote audit based on a risk assessment that considers the nature of their products and service, their technical capabilities, and factors such as compliance histories and quality trends”. In no case was a remote audit appropriate if the firm had unresolved issues that were observed during previous audits that required an on-site visit.
It is therefore mandatory that every business conduct an initial risk assessment and document the outcomes achieved through remote auditing, including plans that will go into effect when current restrictions are lifted to ensure on-site audits can resume in a timely manner.
The following considerations are vital in planning an audit:
- Legal agreements barring electronic recordings of screen- shares, livestreams, or other media transmitted remotely.
- IT service preparation for firewalls, software limitations, and security risks.
- Deployment of video conferencing capabilities.
- Availability of secure document sharing services.
- Connectivity and A/V checks in case of a live walkthrough of the facility.
- Ensure that data privacy requirements (HIPAA, GDPR) are met in accordance with audit processes.
Remote facility reviews and interviews can be conducted in a digital conferencing mode, like in-person interviews through secure teleconferencing systems. Digital platforms have emerged which enable live 360° real time audit to help you review more places in less time. A 360° camera, along with a selfie stick and audio headset, enables you to conduct live virtual tours while speaking directly with remote guests. All data is exchanged in electronic formats such as MS Word, Excel, PDF files, text files and EDI files. If many of the documents and records are made available ahead of time by email or via a website service such as Box.com, then the auditor can proceed with document review. Zoom, WebEx and Facetime are examples of available technology for tours and other options for video conferencing. Some of these vendor services include specialists, such as former FDA inspectors and CQA certified auditors who are proficient in conducting mock inspections, internal audits, vendor and supplier auditing, and gap assessment services.
A virtual/remote audit is an excellent solution to allow for business continuity and assurance that critical suppliers as vendors continue to function within a state of compliance as an extension of a firm. Considering the wide-spread global nature of drug manufacturers and their suppliers, the digital virtual audit promises to transform the onerous task of compliance to a desirable win-win outcome for greater patient safety.