The Good Manufacturing Practice (GMP) audit is a cornerstone of your business' ability to create and distribute regulated items such as food, medical devices, pharmaceuticals, etc. It is vital that this procedure takes place in order for it to uphold its standards in the industry.
An all-encompassing and well-executed GMP audit offers an in-depth view of how your business is meeting relevant GMP standards, as well as clarifying which areas require improvement. This review is an organized assessment of your facility's performance to check if it meets all the requirements labeled by
Given this reality, prepping for an audit can be difficult and the experience itself intimidating. Nevertheless, by following these steps you will find that the entire process is much easier than anticipated.
What is a GMP Audit?
An audit of a manufacturer's Good Manufacturing Practices (GMPs) is the practice of an internal or external individual or team verifying that they are following established standards.
Similar to an audit in the accounting or financial fields, a GMP audit inspects production processes for their compliance with quality control standards instead of examining financial papers. The main mission behind this type of assessment is guaranteeing that all products are dependable and produced consistently in order to meet customer specifications (for instance, each item should appear and work identically every time).
Whether you are dealing with private firms or governmental agencies, it is essential for manufacturers to comprehend the nuts and bolts of audits as well as their impact on your business.
To ensure compliance with GMP regulations, the quality system approach involves the assessment of all or any of its five subsystems:
● Facilities and Equipment
● Laboratory Controls Understand the GMP Audit Process: What to Expect and How to Prepare.
Here's an overview of the typical steps involved in a GMP audit:
● The auditor strategizes and organizes the audit with precision.
● The auditor concludes the introductory meeting.
● The auditor gathers information and evidence by investigating documentation, talking to staff members, observing firsthand experiences, etc.
● As part of their investigation into your organization's systems and procedures for ensuring GMP compliance, the auditor will carefully document all related information (such as manufacturing records).
● After each phase of investigation into your organization's GMP-related systems and procedures, the auditor will produce a written report that encapsulates their findings. This comprehensive document shall serve as an invaluable source of insight to guide you forward in executing best practices within your enterprise.
To begin, auditors obtain the required information onsite or through conversations with personnel who work there (like management and staff). They also scrutinize records which have been compiled beforehand by operators in their regular tasks (such as batch record sheets). By basing it off of what they discovered during their elementary analysis activities, they will then design and execute audits—this is referred to as “audit planning”.
During the second phase of the audit, various activities are conducted to ensure accuracy and detail. Documentation is collected from visits; supporting documents such as records or manuals are obtained; interviews with individuals involved in key processes occur for more thorough descriptions than what may be found on SOPs; batch data generated through production operations is reviewed; physical evidence related to critical control points like product stability tests results are observed, and a plethora of other important assessment tasks take place.
The audit report that follows should be transparent, succinct and comprehensible. It requires a concise summary of findings, advice for corrective action, an inventory of nonconformances and other insights as applicable.
How to Prepare for a GMP Audit Life-science leaders must take proactive steps in order to fully prepare for upcoming internal or external audits.
Prior to beginning any audit, it is crucial to revisit past FDA inspections and audits. This should include reviews of SOPs applicable to the particular areas being examined as well. In order for leaders to maximize their resources and utilize time efficiently, a comprehensive plan featuring deadlines and essential personnel must be established.
Before the actual audit, all team members should do a thorough pre-audit check to ensure that each of them are prepared for their individual roles. This includes confirming contracts and other paperwork is ready, as well as making sure all necessary equipment (such as computers) have been tested and set up prior to auditors coming into your facility.
If you're looking for extra guidance on how to prepare for a GMP audit, here are some fast tips:
● Prior to the audit, create an organized list of all required documents and ensure they are easily accessible. This will save you time during the audit as you won't need to waste energy searching for them.
● In order to remain compliant with GMP regulations, it is essential that you maintain a checklist on hand at all times of everything necessary for compliance. Having checklists in place like equipment maintenance and cleaning schedules ensures that everything is up-to-date and functioning optimally so there are no surprises during inspections or audits.
In order to hold a successful GMP audit, preparation is essential.
● Ensure that all necessary documents are in order. Your company must have its official paperwork ready to present upon request. It's important to take care of any changes or additions prior to the audit arrival, so there are no unexpected issues during inspection time. By attending to these details beforehand, your business can confidently prepare for and withstand a thorough evaluation without issue!
● To ensure a successful process, appoint someone to be available at all times. Additionally, provide high-quality facilities for the parties involved so that they can work in comfort and reduce any potential stress which may result in communication mistakes later on.
● Ensure that your "war room" is stocked with all essential supplies. This includes an organizational chart, facility layout, Quality System Manual, SOPs and Staff Training Documentation - but don't forget to check for anything else you may need!
Common Mistakes Made During GMP Audits
● Failing to adequately prepare for an audit.
● Having a lack of comprehension regarding GMP regulations and the auditing procedure.
● Failing to organize and keep track of essential documents before the audit.
● Inviting the wrong personnel to attend the audit.
● Not having the essential gear for testing.
Our experience performing thousands of audits for FDA-regulated companies have exposed us to various prevalent errors and obstacles. We understand precisely how to properly plan and execute a successful audit, so do not hesitate to reach out if you would like more information on the matter!
To ensure that your GMP auditing process runs smoothly and efficiently, keep the following best practices in mind:
● It is essential that all of your personnel are informed about the audit.
● Guarantee that your employees possess the necessary knowledge and expertise for a successful audit.
● Make sure that your team is equipped for the audit. If you don't have usual employee meetings, try to plan one ahead of any assessment or audit so everyone knows what's coming and how they can get prepared.
● Ensure that everyone is aware of the expected standards before an inspection occurs so they are well-equipped to handle surprises and any issues that may arise.
Final Thoughts and Next Steps
GMP audits are an integral part of the production process and Quality program, guiding customers and regulators to trust that products meet quality standards, safety regulations, as well as any other rules in effect at the moment of manufacture. These assessments make sure your clients feel secure knowing their health & safety is a priority while maintaining high-level outcomes.
Don't let a GMP audit be a daunting experience - with proper preparation, quality auditing professionals and adherence to best practices you can make sure that your company's next GMP audit goes smoothly. Most importantly, by having confidence in your state of compliance you can feel at ease during the process.
Adhering to the FDA's GCP, GLP, and GMP inspections is paramount in order for pharmaceuticals, medical devices, or any other medical products to be safe and effective. However this often appears an insurmountable task for industry leaders who are constantly trying to meet these obligations.
Our successful cooperation with various life-science entities has proved to be a success time and time again. By partnering together, we can guarantee excellent product investigation, fabrication and above all else, public safety. Learn about FDA consulting here.