The pharmaceutical industry requires specific storage and packaging to keep medicinal products safe and viable during the shipping process. From temperature-controlled units, to educating and training the personnel handling the medicine, shipping pharmaceuticals requires diligence and has many specifications that need to be met.
In this blog post, we will explain:
- The legal regulations on shipping pharmaceuticals
- The basics of the pharmaceutical logistics
- The necessity for quality personnel
Legal Regulations on Shipping Pharmaceuticals
Given how dangerous and complex pharmaceuticals are, the Food and Drug Administration (FDA) has established specific guidelines that all distributors and their partners must follow. Recordkeeping is also very critical to state and local law enforcement, who can inspect your processes at any time. Records must be available for at least three years after creation, and documents must cover:
- Specific procedures for every product’s arrival and departure
- Quarantined, destroyed, and returned pharmaceutical goods
- Examination of materials
- Detailed temperature and humidity records of the storage environments of each drug
When to Quarantine, Return, or Destroy Drugs
A drug must be quarantined, returned, or destroyed if it falls within any of the following parameters:
- Broken seal
Title 21 outlines many other regulations regarding shipping prescription drugs.
The Basics of Pharmaceutical Logistics
Stat Experts chain of custody procedures ensure a consistent temperature is maintained during the entire pharma transportation process. This is important because even the slightest temperature variation can cause the active chemicals of the medication to change molecular form. This alteration could make the medication inefficient, dangerous or even do something different than its original intent.
Technology, such as data loggers, GPS trackers, and temperature controlled coolers are some of the resources implemented by Stat Experts as Quality Control measures.
The Necessity of Quality Personnel
Specialized pharma shipments require the Stat Experts team to be fully trained on the following for pharmaceutical transports:
- Client specific procedures for packaging
- Client specific procedures for shipping
- Transparent Chain Of Custody procedures
- Transparent Temperature Control procedures
- Secure Proof of Deliveries for every shipment
- Client-specific contact list for logistical issues
Learn More About How to Ship Pharmaceuticals
Stat Experts is a medical logistics company that wants to help educate others on the importance of the pharmaceutical shipping process. It is important that pharmaceutical organizations work with a company that understand the intricate needs of the pharmaceutical shipping industry.