Remote FDA Inspection Audit
Maintaining GMP and GCP Inspection Readiness in a Remote-Audit World
Medical device, pharmaceutical and life science companies are feeling the impact as the coronavirus pandemic forces a suspension of normal operations and a transition into unexpected and unprecedented ways of doing business. International and domestic travel is being discouraged and standard business travel practices disrupted, rendering existing GMP inspection and audit schedules moot and leaving manufacturers to wonder how to ensure adequate inspection preparation and readiness.
While the FDA and other regulators have cancelled on-site inspections for the duration of the outbreak, they are still performing remote inspections in certain situations, and remote GMP audits remain a viable option for well-prepared manufacturers. Strategic companies can use this enforced downtime to strengthen their quality management systems, partnering with an experienced auditor to identify gaps in their documentation and processes, create action plans to mitigate noted deficiencies and ensure GMP inspection readiness for whenever normal FDA operations resume.
Are Remote GMP and GCP Audits Possible?
This is an increasingly digitized world, and the move to remote GMP and GCP audits and inspections has remained somewhat behind the curve due to confidentiality and credibility concerns. Although on-site audits and inspections will always be preferred, there are no restrictions in GMP regulations, standards or guidance documents to prohibit remote audits and inspections. Cloud-based computing and storage, video conferencing, screen-sharing and other IT advancements have become accepted business practices, so it stands to reason that a remote GMP or GCP audit can be just as efficient and effective as one performed onsite.
Per ISO 17021, the first stage of a certification audit requires extensive review of data, documents and records, but a remote GMP audit can also include much more. The more connectivity options that are available, the more like an actual on-site audit the remote version becomes. A multi-media configuration allows auditors to request and receive documentation from multiple locations and interact with multiple teams, interviewing individual members as needed and asking for real-time demonstrations of processes without invoking the expense and time of multi-site travel.
However, if a remote GMP or GCP audit or inspection is to be successful, the facility technology must be strong enough to support seamless communication and delivery of documentation to the remote auditor. Anyone who has ever been on a conference call, video conference or webinar knows that the quality of the meeting rests squarely on the strength of the technology used, and the same applies to remote GMP audits. It is a good idea to perform a feasibility study of the following variables to determine if the remote audit option can be adequately supported:
- Security/Access to the Online Portal
- Telephone or Video Conference Capacity
- Screen-Sharing Capability
- Wi-Fi Signal Strength
- Computer Hardware and Connectivity
- IT Redundancy and Back-up Plan
As digital technology continues to improve, virtual or augmented reality audit configurations may become more common, replacing an auditor’s on-site presence with remote observation of quality processes on the production floor. However, use of this advanced technology will depend on the nature of the audit, the company and the auditor, and may not be a fit for all industries or situations.
MDSAP and Remote GMP Audits
The ready availability and adoption of web conferencing and screen share technology has finally convinced regulators to take a long and serious look at defining the requirements for remote audits. The FDA’s Medical Device and Single Audit Program (MDSAP) has launched a pilot program to gauge the viability of remote device marketing authorization (DMA) and facility registration audits. These remote audits are not intended to replace the two-stage, on-site audits defined in ISO 17021, but can help make auditors more efficient – and save the manufacturer money – by allowing auditors to review much of the manufacturer’s quality management system (QMS) documentation prior to arrival at the facility.
This voluntary remote auditing program mandates that the remote audit replicate the on-site audit as much as possible in both scope and operation. After the audit is completed, regulatory consultants and agencies must complete a survey grading the success of the remote audit and submit to MDSAP. If the eighteen-month pilot is judged a success, remote audits may become more the norm for MDSAP as they have with other regulatory agencies, saving manufacturers both time and money on the road to product launch.
Clinical Trials and Remote GCP Audits
Clinical trials also are subject to regulatory audits to ensure that good clinical practices (GCP) are being followed and to assess compliance with regulatory requirements. The auditor verifies that the clinical trial protocol is being followed, the study’s clinical quality management plan (CQMP) is complete and the study results properly documented. The audit also verifies that the principal investigator and all associated study support personnel have the appropriate credentials, and that the trial site has the resources to maintain compliance throughout the duration of the study.
With the disruptions caused by the COVID-19 outbreak, there may be supply chain issues, site closures, staff quarantines and other issues that challenge investigators and sponsors ability to maintain compliance with the original clinical trial protocol. The FDA, realizing that there may be unavoidable roadblocks, has issued a new guidance document to assist clinical trial investigators and sponsors in determining the best way to proceed with the trial in the face of these potential disruptions. This new guidance speaks to the safety of trial participants, the potential for alternative methods of sample and data collection due to closures and quarantines, and the possibility of alterations to the original study protocol with approval from the site institutional review board (IRB). The new guidance also specifies how to document any data or sample collection that is missed because of COVID-19 restrictions or infection, but the FDA is clear that it expects the study sponsor, IRB and investigators to do what they can to avoid changes to the protocol and to carefully document any deviations from the original plan.
What Is Reviewed During a Remote GMP or GCP Audit?
As discussed earlier, a review of almost everything – including a virtual tour of the production facility – can be performed during a remote audit. Quality system documentation serves as evidence of a manufacturer’s alignment with the golden rule of compliance – Say What You Do and Do What You Say – so documentation review remains the primary focus of any remote audit. The documents that the auditor will want to review include:
- Quality manual and procedures
- Management review
- Employee qualifications
- Compliance and non-conformance logs
- Corrective and preventive action logs
- Design history files or drug master file
- Testing and validation plans
- Process controls
- Maintenance records
- Employee training requirements and training records
- Complaint handling logs
- Adverse event reporting logs
- Post-market surveillance
The auditor will also want to see evidence of the company’s internal audits. These can include:
- Procedural and documentation gap analyses
- Documentation audit (creation, revision and obsolescence trails)
- Management review of the quality system documentation
- Employee credentials and qualifications
- Employee training processes
Review of any remote vendor qualifications can also be part of a remote GMP audit. But there are some audits that just cannot be performed remotely. The FDA does not recommend using remote audits to qualify suppliers, as too much valuable information is gathered by touring the facility and directly observing production site processes and cleanliness. The document review performed during a remote audit provides only a partial representation of supplier compliance, and the full picture can be determined only with an on-site inspection.
How to Get the Most Out of a Remote Audit
As with any inspection, preparation is key if a company is to have a successful and productive remote audit. Whether auditing in advance of a pre-approval, post-approval, surveillance or for-cause inspection, manufacturers should take the time to prepare for the audit just as they would for a full FDA inspection. There are FDA procedures available to help companies prepare for pre-approval and post-approval and surveillance inspections, and aligning with the following can also help ease any pre-inspection and audit stress:
- Educate staff on applicable FDA and GMP regulations and requirements
- Discuss any significant issues with senior management prior to the audit
- Develop an audit plan, and assign roles and responsibilities
- Ensure that all assigned personnel are readily available to the auditor
- Perform a test run of all software, cellphone and video connectivity setups
- Provide any information requested by the auditor prior to the start of the audit
- Review applicable FDA and GMP guidance documents
The most common stressor described by company employees during an audit or inspection is fear – of not being able to answer the auditor’s questions, of not knowing where to find a requested document, of somehow negatively influencing the auditor or inspector. But if the audit preparation process includes any employee likely to be interviewed during the inspection and employees actively participate in management and review of the QMS, then they should be adequately prepared for the audit.
How Premier FDA Solutions Can Help
If a manufacturer doesn’t have a robust quality management system in place, an audit can highlight the areas that need attention before the FDA inspectors come calling. Bypassing the GMP or GCP audit process is not a strategic move, as it simply means deferring the costs of compliance until after the inspection, when the FDA hands over their report and the facility’s deficiencies are made clear. This delays product launch and can have a negative effect on a company’s bottom line.
Premier FDA Solutions understands the importance of maintaining a proactive quality management system, and we have a range of right-sized audit services to meet your needs. We assist you in reducing FDA inspection risk through mock audits, inspection readiness checks, gap analysis, validation and internal and supplier GMP audit services. Contact us at www.premierfdasolutions.com and let us handle your compliance questions so you can remain focused on growing your business.