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FDA Inspection Procedure

Q: Companies have made a lot of operational changes to accommodate working through the pandemic. What changes do you think will become permanent in FDA inspection procedure as a result of the pandemic?

 

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.

 

Documentation Procedures

 

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.

 

About the Publisher

 

 

About RCA’s听Pharmaceutical Consulting Services

 

Regulatory Compliance 黄人导航 (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance 黄人导航 offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance 黄人导航 team knows the unique inner workings of the regulatory process.听

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance 黄人导航 will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

 

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Regulatory affairs is Regulatory Compliance 黄人导航 backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

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The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance 黄人导航, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
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Quality Assurance

 

Regulatory Compliance 黄人导航 Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance 黄人导航 quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

  • 21 CFR Part 11
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Remediation Services

 

Regulatory Compliance 黄人导航 has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance 黄人导航 pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance 黄人导航 pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

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About Regulatory Compliance 黄人导航

 

pharmaceutical consultantsRegulatory Compliance 黄人导航听(RCA) provides pharmaceutical consulting to the following industries for resolution of life science 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 , , and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory听due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company鈥檚 unwavering commitment to its mission, Safeguarding Global Health.

 

Sotera Health Company, along with its three best-in-class businesses 鈥 ,听听and听, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

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