Does FDA enforce GDP?

Recommendation

28/29 September 2021

Live Online Training: The GDP Compliance Manager

Good Distribution Practice and its respective GDP Guidelines are certainly a hot topic in the EU and in WHO states. In the US, things are still developing but are getting more and more important - even though storage and transportation issues were also a topic in past FDA inspections. This is mainly based on 21CFR Sec. 211.56 "Sanitation" where it says that "Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition. Any such building shall be free of infestation by rodents, birds, insects, and other vermin." It is also based on subpart H "Holding and Distribution". And this also includes warehouses and storage facilities, as the following excerpts from recent Warning Letters show:

Quality System

"During our inspection, we found your quality unit did not approve your written standard operating procedures (SOPs) for numerous critical processes, such as quality unit responsibilities, (…), material quarantine, product distribution, (…), product return, (…), raw material testing, …"

Premises:

"Our investigator documented copious amounts of unknown black, mold-like material on the floor and walls of warehouse #2. In addition, our investigator observed standing water on the floor and live insects at the entrance of the same warehouse."

"Your firm failed to keep the buildings used (…) free of infestation by rodents, birds, insects, and other vermin (…) throughout the warehouse, around both raw materials and finished drug products."

Receipt of medicinal products

"Your firm receives drums of […] raw material from your supplier without any identifying labels".

"When our investigator asked for a list of your critical raw materials and your sampling requirements, you told our investigator that you had no written procedures for testing and sampling incoming materials. Instead, you explained, your warehouse employees accounted for incoming raw material handling, sampling, and testing 'in their heads'."

Inspection management

"You delayed FDA's access to the warehouse and limited FDA's inspection by removing the drums before our investigators could inspect them."