How to be GMP audit-ready for cell and gene therapy manufacturing
How to be GMP audit-ready for cell and gene therapy manufacturing
In the intricate world of pharmaceutical manufacturing, precision and quality are not just goals; they’re a regulatory imperative. Good Manufacturing Practices (GMP) audits are the backbone of quality assurance, ensuring that each pharmaceutical product meets the stringent standards essential for safeguarding public health.
The FDA and EMA do not take their roles lightly when it comes to protecting patients and can come by anytime - announced or unannounced - to perform these audits. It's a source of perpetual anxiety, especially for regulatory departments, and the entire organization feels the weight of maintaining regulatory compliance.
But fear not! We've got your back. Dive into these tips to make gearing up for audits a smoother journey, minimizing the last-minute hustle and ensuring your organization is GMP audit-ready for cell and gene therapy manufacturing.
1. Establish an audit team
Establishing an audit team is your first step on the path to GMP audit readiness. Anticipation is key, so ensure you're well-prepared well in advance before the auditor's arrival. Form a cohesive team where everyone knows their role during the audit, creating a smooth and confident presentation.
Kick off by designating a central coordinator who will manage the entire process from A to Z, ensuring every task is accounted for. This person will play a pivotal role in filling essential roles, such as assigning a knowledgeable team member to guide the auditor through a tour of the facility. While this guide doesn't need to be an expert in every department, they should have a solid understanding of how different departments interconnect, fostering a seamless flow.
In each location, enlist deep-dive experts who are well-briefed in advance and readily available throughout the audit. These experts are your go-to authorities, ready to answer questions and provide comprehensive explanations on their subject matter.
To tackle this challenge effectively, do a “dry-run” of the audit tour. In this practice session you can ensure hosts are well-prepared and confident in communicating with auditors.
By preparing the audit team, you not only minimize confusion but also facilitate auditors in accessing the information they need smoothly, putting your best foot forward and showing control over your facility.
2. Understand your auditors
If you know of your audit in advance, take some time to do some background research on who will perform the audit. Knowing their area of expertise could help you know what they could focus on the most to better prepare responses to their questions.
3. Regularly review your SOPs
Regulatory compliance is brought to life through an organization’s Standard Operating Procedures (SOPs). As GMP audits scrutinize every detail of operations, these guidelines not only steer daily operations but are also proof to auditors that an organization is staying up to code. From the isolation of genetic material to the parameters on how to cultivate cells, SOPs detail each critical step, offering auditors a clear roadmap of how an organization is adhering to GMP guidelines.
The first thing auditors do with regards to SOPs is doing a thorough review. Auditors seek not just compliance but a deep understanding of the processes, and SOPs serve as the foundation. Regular updates to SOPs reflect the commitment to continuous improvement, incorporating lessons learned, staying up-to-date with the latest regulations and industry advancements.
However, the documentation is only half the story. Auditors will then look at how the SOPs are brought to life by reviewing training records and looking at the processes within the organization to see if employees are following the guidelines.
The good news is that today it is easier than ever to enforce SOPs and know who is up to date with their training thanks to software like MyCellHub. MyCellHub’s training module was built for exactly this purpose, and SOPs are carried out in part with interactive work instructions. With interactive work instructions, operators are given step-by-step tasks and send error warnings if a step is skipped. These two features help relieve some of the anxiety of the quality team as they can have a better overview of operations and get reports whenever they wish.
4. Organize and store your data
Once your team and processes are in place, you’re going to want to have a fool-proof way to find the documents you need when you need them. Auditors are going to want to see that your processes, deviations, corrections and workflows are available, easy to find and clear. And that the data is managed properly - an organized system in which you can quickly produce a document when asked shows that you are in control.
Having a controlled event management system, as described in an SOP, makes it easier to give details. Anyone working in life sciences knows that accidents do happen, no one is perfect. But if an event is well documented, rated and resolved with a successful investigation, this gives confidence to an auditor that your process is under control.
More and more organizations are moving away from paper-based systems and spreadsheets as software alternatives on the market show the ease to keep data organized. Software makes it easier to follow the data and features like barcode scanning make data entry seamless. And extensions like device integration allow software and hardware to constantly be streaming data, to have the most comprehensive view on what is happening in a machine.
5. Stay on top of data protection and security
Are your controls and electronic audit trails up to scratch? Who has access rights to what information? Your auditor will want to know what systems you have in place to safeguard information within your facility.
The connection with your IT department will be essential for this part of the audit. Once again, software helps with this part as users can be managed from a central location and electronic signatures ensure traceability.
Stay in control with MyCellHub
All-in-all, audits are very stressful events for any organization. But staying organized and using software systems like MyCellHub to keep workflows in line and data accurate, well-managed and secure makes many aspects of staying audit ready much easier.
Why not get in touch to see if MyCellHub is right for your facility?
In the intricate world of pharmaceutical manufacturing, precision and quality are not just goals; they’re a regulatory imperative. Good Manufacturing Practices (GMP) audits are the backbone of quality assurance, ensuring that each pharmaceutical product meets the stringent standards essential for safeguarding public health.
The FDA and EMA do not take their roles lightly when it comes to protecting patients and can come by anytime - announced or unannounced - to perform these audits. It's a source of perpetual anxiety, especially for regulatory departments, and the entire organization feels the weight of maintaining regulatory compliance.
But fear not! We've got your back. Dive into these tips to make gearing up for audits a smoother journey, minimizing the last-minute hustle and ensuring your organization is GMP audit-ready for cell and gene therapy manufacturing.
1. Establish an audit team
Establishing an audit team is your first step on the path to GMP audit readiness. Anticipation is key, so ensure you're well-prepared well in advance before the auditor's arrival. Form a cohesive team where everyone knows their role during the audit, creating a smooth and confident presentation.
Kick off by designating a central coordinator who will manage the entire process from A to Z, ensuring every task is accounted for. This person will play a pivotal role in filling essential roles, such as assigning a knowledgeable team member to guide the auditor through a tour of the facility. While this guide doesn't need to be an expert in every department, they should have a solid understanding of how different departments interconnect, fostering a seamless flow.
In each location, enlist deep-dive experts who are well-briefed in advance and readily available throughout the audit. These experts are your go-to authorities, ready to answer questions and provide comprehensive explanations on their subject matter.
To tackle this challenge effectively, do a “dry-run” of the audit tour. In this practice session you can ensure hosts are well-prepared and confident in communicating with auditors.
By preparing the audit team, you not only minimize confusion but also facilitate auditors in accessing the information they need smoothly, putting your best foot forward and showing control over your facility.
2. Understand your auditors
If you know of your audit in advance, take some time to do some background research on who will perform the audit. Knowing their area of expertise could help you know what they could focus on the most to better prepare responses to their questions.
3. Regularly review your SOPs
Regulatory compliance is brought to life through an organization’s Standard Operating Procedures (SOPs). As GMP audits scrutinize every detail of operations, these guidelines not only steer daily operations but are also proof to auditors that an organization is staying up to code. From the isolation of genetic material to the parameters on how to cultivate cells, SOPs detail each critical step, offering auditors a clear roadmap of how an organization is adhering to GMP guidelines.
The first thing auditors do with regards to SOPs is doing a thorough review. Auditors seek not just compliance but a deep understanding of the processes, and SOPs serve as the foundation. Regular updates to SOPs reflect the commitment to continuous improvement, incorporating lessons learned, staying up-to-date with the latest regulations and industry advancements.
However, the documentation is only half the story. Auditors will then look at how the SOPs are brought to life by reviewing training records and looking at the processes within the organization to see if employees are following the guidelines.
The good news is that today it is easier than ever to enforce SOPs and know who is up to date with their training thanks to software like MyCellHub. MyCellHub’s training module was built for exactly this purpose, and SOPs are carried out in part with interactive work instructions. With interactive work instructions, operators are given step-by-step tasks and send error warnings if a step is skipped. These two features help relieve some of the anxiety of the quality team as they can have a better overview of operations and get reports whenever they wish.
4. Organize and store your data
Once your team and processes are in place, you’re going to want to have a fool-proof way to find the documents you need when you need them. Auditors are going to want to see that your processes, deviations, corrections and workflows are available, easy to find and clear. And that the data is managed properly - an organized system in which you can quickly produce a document when asked shows that you are in control.
Having a controlled event management system, as described in an SOP, makes it easier to give details. Anyone working in life sciences knows that accidents do happen, no one is perfect. But if an event is well documented, rated and resolved with a successful investigation, this gives confidence to an auditor that your process is under control.
More and more organizations are moving away from paper-based systems and spreadsheets as software alternatives on the market show the ease to keep data organized. Software makes it easier to follow the data and features like barcode scanning make data entry seamless. And extensions like device integration allow software and hardware to constantly be streaming data, to have the most comprehensive view on what is happening in a machine.
5. Stay on top of data protection and security
Are your controls and electronic audit trails up to scratch? Who has access rights to what information? Your auditor will want to know what systems you have in place to safeguard information within your facility.
The connection with your IT department will be essential for this part of the audit. Once again, software helps with this part as users can be managed from a central location and electronic signatures ensure traceability.
Stay in control with MyCellHub
All-in-all, audits are very stressful events for any organization. But staying organized and using software systems like MyCellHub to keep workflows in line and data accurate, well-managed and secure makes many aspects of staying audit ready much easier.
Why not get in touch to see if MyCellHub is right for your facility?
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