You have a cGMP program in place and are confident you are in compliance. Why does it matter if you include a 3rd party auditor like Carter Regulatory Group (CRG) to conduct audits of your systems and facility? Compliance is kind of like a stinky car – you get used to your own systems and become blind to the reality – you aren’t in as good of shape as you think. This is why including a 3rd party like CRG is so important. You need someone without internal bias to come look at your systems, just like the FDA would. They can help you understand whether your systems are understandable, whether they follow industry standards, or whether they would pass FDA muster.
So what does this type of thing cost? On average, an audit is going to run you $5-10k per year. If you use reputable companies like CRG, the goal will be to not just get a certificate of compliance, but to continually improve your program. This is also why it’s important to engage a company who audits across multiple industries and sees best practices throughout the world. These types of auditors can provide the most practical and up to date feedback, allowing you to stay at the head of industry trends.
You never know when the FDA is going to show up, so don’t wait to have your dirty laundry aired with an inspector. Hire a 3rd party auditor to inspect your facility and program now so you are well prepared for when the real inspection occurs.