The FDA is taking a New Approach to Inspections because of the Pandemic. Learn about the Hybrid Approach →
A: There are a number of operational changes that companies have made to accommodate working through the pandemic. Many of the changes were implemented out of necessity. That is to say, some of the changes have the potential to become normal operating procedures. Patients still need life-saving medicines.
Likewise, companies need to find ways to continue manufacturing safe, effective, and compliant products. Conducting virtual audits, virtual training, and enhancing communications with suppliers are among the changes implemented. The goal is to ensure an uninterrupted supply chain to maintain operations and stay compliant. Each of the changes have positive and negative aspects that need to be evaluated to determine if they are effective.
Virtual Audit Procedures
Moving to virtual audits was one of the first changes that was implemented by companies and regulatory authorities. The necessity for virtual audits was to allow companies and regulators to continue to evaluate the compliance stature of manufacturers while respecting stay-at-home and social distancing requirements that prevented in-person site audits.
There are many advantages of performing virtual audits and the key to making a virtual audit successful is preparation and communication. Informational (organizational charts, standard operating procedures, quality manual, etc.) requests should be made prior to the audit, and the requested documents should be reviewed before the commencement of the audit.
Companies can save time and reduce travel expenditures because people will be reviewing documents from home offices. The documentation required for in-person audits will be the same as virtual audits, but rather than making copies for the auditor, the documents can be turned into a PDF file and be sent through a secure system to the requester. Questions regarding the documentation can be addressed through a number of virtual platforms as long as the platform chosen is acceptable to both parties.
FDA Inspection Facility Tour Procedures
Performing a tour of the facility poses unique challenges, and possible solutions need to be vetted between the two parties to determine the most efficient and secure way to share this information. The bottom line is that virtual audits have the potential to be as effective as in-person audits and perhaps maybe more time efficient and cost-effective.
FDA Inspection Virtual Training Procedures
The same principles applied to conducting virtual audits can also be applied to training. On-line training programs have been used to train remote employees for years. There are a number of technological platforms that can be used to deliver virtual training programs to employees. These platforms allow training material to be pre-recorded and comprehension questions that must be answered correctly in order to continue with the training can be inserted. Remote training allows the employee to
complete the training as their schedule allows.
Another approach is to deliver the training as a webinar using a multiple-person meeting application. You can prepare and distribute the information you will cover in the training, schedule a meeting time, deliver the training, and take questions from the employees during the webinar. If you have multiple manufacturing shifts, you can schedule a training session during each shift to make it easier for second- and third-shift employees to receive the training.
Additionally, virtual training can be enhanced by taking advantage of online training and conference options offered by external organizations. Many external organizations have converted their conferences and training topics to virtual offerings covering a wide variety of topics. Some of these venues are free, and some require a registration fee.
FDA Inspection Supply Chain Procedures
Enhanced communication with suppliers to ensure an uninterrupted supply chain has also become a priority during the pandemic. Many companies are reviewing and enhancing their quality agreements. This is a positive change for the industry as a whole.
The quality agreement should be a living document that is reviewed and revised as often as needed to clarify the responsibilities of the client and the supplier and define how the two parties will communicate with each other. The agreement should clearly identify the roles and responsibilities needed for a successful partnership.
FDA Inspection Supplier Quality Procedures
Defining the quality relationship between a supplier and a client is complex and requires extensive discussion and attention to detail. The relationship should be open, and communication between the two parties should be as frequent as required to assure that the product being manufactured meets the highest quality standards for the client and for the patients. Bottom line is that quality agreements are important documents for ensuring the supply chain procedures during the pandemic. This is a welcome change that should carry forward in the future.
There are many changes that have the potential to become permanent procedures or operating principles even after the pandemic. Three that should become permanent in the future are the use of virtual audits, the implementation and utilizations of virtual training, and more robust quality agreements that enhance communications between the client and the supplier.
Regulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Regional offices in Florida, Colorado and Europe
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021