REAL Solutions Group has built a consistent and successful track record of helping our clients achieve NABP Drug Distributor Accreditation (formerly known as VAWD). We don’t think anyone can say they’ve seen it all, but we can say with certainty we’ve seen a lot!
Here are the top compliance issues we come across when helping prepare clients for NABP Drug Distributor Accreditation:
Issues with sources and customers.
These issues include a failure to:
Buy from an authorized trading partner;
Verify the legitimacy of product;
Authenticate the source or customer;
Document the transaction; and/or
Comply with DSCSA transaction history record keeping.
All manner of P&P issues. Technical writing is a bear and it trips up even the most seasoned industry experts. Your P&Ps are the backbone of your company’s culture of compliance; as such, NABP is meticulous in its P&P review process. Some of the common noncompliance issues we see regularly include P&Ps that are:
Not current or accurate;
Lacking in clarity and clear direction;
Incomplete or conflicting information.
Temperature and humidity monitoring. Temperature and humidity monitoring is a 24/7/365 process. Sensors must be calibrated annually, and temperature mapping must be done to validate locations of sensors. NABP will check to make sure your temperature monitoring is effective and expects temperature mapping to be timely completed.
Validated shipping containers. Shipping refrigerated or frozen products in cartons or containers that have not been validated to maintain the required temperature of the product during summer and winter conditions. The validation data must be obtained and maintained by the facility to include the pack-out diagrams to protect the product from getting too hot or too cold during shipment.
Security. There are several ways insufficient security measures can result in noncompliance. For visitors, this is typically the company’s failure to keep an accurate visitor log or escort visitors in product storage areas. For staff, noncompliance issues include a lack of job descriptions or defined duties, background checks, drug testing, or formal training program.
A Few More to Consider. These compliance issues are not the most common, but are some of the most important:
Affiliations with entities with questionable business practices;
Lack of temperature control system (HVAC) in product storage area;
Shipping without a license; and
Failure to report to FDA.