GMP compliance is one of our core service areas. We help provide compliance with current GMPs for an FDA-regulated facility. To help achieve this, VPCI offers a wide range of support services including gap assessments, on-site training programs, and FDA inspection support.
Our gap assessments are designed to report on the current status of your quality system and to highlight areas for upgrades to comply with FDA expectations. Our consultants follow a detailed audit program to gain a deep, hands-on understanding of your facility and procedures. Throughout the process we view ourselves as your partner to help resolve issues in the best possible way. Our successful approach is based on our longtime industry experience.
In the area of FDA inspection support, we provide mock inspections following the FDA inspection approach. A mock inspection will test your facility and personnel for the ability to successfully complete a real inspection. In addition to advance preparation for an upcoming inspection, VPCI can also directly participate during the actual FDA inspection. We will act as a liaison between your personnel and the FDA, often satisfying inspectors before they may issue a formal observation (Form 483).