VCI can help you with: what needs to be done, but not how to do it. VCI will help you find out how to do do it, AND stay within the budget. For instance 21 CFR 110.35 (c) says “No pests shall be allowed in any area of the food plant.” But what does that mean operationally. We show you how your company's sanitation procedure should describe what tasks will be done to ensure that there are no pests in the plant, when or how often these tasks will be done, where they will be done, who will be responsible, and how success will be monitored.
Does everyone on your team know that a mouse can crawl through an opening of less than a quarter of an inch? Does everyone know what the microbial growth curve is? VCI's training seminars and e-Learning courses will insure that you have the knowledge that you need to be compliant.
VCI's GMP Certification system assures you and your customers that you are producing your products in compliance with the current Good Manufacturing Practices regulations which are required by US-FDA. Your customers can call VCI at any time to confirm your certification.
Benefits of VCI's Good Manufacturing Practices Verification Program:
- Increases your credibility and gives you a competitive advantage in the marketplace
- Display VCI's shield on your marketing literature
- Increases senior management confidence that you are ready for FDA inspections
- Demonstrates independent third-party verification of continuing conformance to GMPs
- Confirms that your customers are getting the best products available
When you pass VCI's GMP Verification audit, you earn the right to display VCI's "GMP Verified" seal.
How the process works:
When you apply for GMP Verification by Validation & Compliance Institute we will audit your facility. The audit is a two-way educational opportunity. We learn about your operation while your your employees gain from our broad experience. The cost of the GMP audit depends on the size and complexity of your operation.
- If you achieve a GMP audit classification of A, you will be awarded a certificate and will be allowed to display the VCI shield on your advertising literature.
- If you achieve a GMP audit classification of B, you will be asked to complete certain action items. Upon completion of those items in a timely manner you will be awarded your certificate.
- If you achieve a GMP audit classification of C, you will be asked to complete several action items and will have to pay for another audit. Upon a successful audit you will be eligible for reconsideration for certification.
- After you have earned GMP certification, you will be audited the following year and then periodically afterwards depending on your audit grade. You must pay the audit fee which is applicable to your facility.
- If your GMP audit is graded A, then we will be back to audit in two years.
- If your GMP audit is graded B, then you will be asked to complete certain action items. If you satisfactorily complete those items in a timely manner, then you will retain your certification. You will have to be audited and pay the fee annually until you earn an A rating.
Significant changes in your process that are covered by GMPs require notification and may require a re-audit.
of your employees who work in the covered area get
VCI's initial AND annual refresher GMP training, plus access to VCI's
Learning Management System. We believe that Knowledge +
Dedication = Performance.
Call VCI now to schedule your audit at 734 274 4680.