□ YOU NEED TO UNDERSTAND THE ECONOMICS OF SOURCE PLASMA
Source Plasma is currently in high demand so there are chronic shortages throughout the industry which drives up the cost per liter. However, this is a specialty business and the few companies that operate in this industry most often own a fractionation facility to process the plasma and package it as a finished pharmaceutical. Of course, there are a few companies that do not own a fractionation facility, so they will contract with the companies that do own to sell their plasma.
You should set up tentative sales agreements before you start your project. This will give you the opportunity to meet industry leaders and understand what price you can sell your product at before you invest.
□ YOU NEED MONEY
Opening a plasma center is not the same as opening a business that does not require oversight by the Food & Drug Administration (FDA). You will need to have money to fund:
- A building in a location that will attract the specific clientele you’re intending to collect plasma from.
- Capital for lease improvements to ensure the building meets FDA requirements.
- Capital to purchase and maintain low temperature freezers.
- Capital for medical equipment.
- Capital for software and software validation (software is considered a 510K medical device and must have FDA approval to use).
- Money to support a full staff, plasma collections, and storage of collections until FDA licensure is obtained.
Because you MUST be licensed to sell Source Plasma, you will be required to test and hold your product in low temperature freezers. You CANNOT sell product until you have obtained FDA licensure.
□ YOU HAVE TO GET COMFORTABLE & ACCEPT THAT YOU WILL BE WORKING UNDER FDA SUPERVISON AS DIRECTED IN THE CODE OF FEDERAL REGULATIONS (CFR)
As a plasma center owner, you will be responsible to ensure your center is in compliance with the required Code of Federal Regulations (CFR’s)(21CFR11, 21CFR600, 21CFR211, 21CFR42, 21CFR820 etc). You are required to document HOW you will maintain compliance in your Standard Operation Procedures.
□ YOU NEED AN SOP (Standard Operating Procedures)
- This is where some new plasma companies have run into their first bit of trouble with the FDA. You are required to have a full set of SOP’s detailing the exact steps to perform every task related to donor suitability, plasma collection, testing and shipping in the center. In addition, you are required to have SOPs for quality control, shipping, product recalls, software maintenance, ongoing validation, change control, certain aspects of human resources management, OSHA and safety management and others.
□ YOU NEED TO UNDERSTAND WHAT VALIDATION MEANS, AND HOW IT APPLIES TO A PLASMA CENTER.
Validation is required testing to PROVE that your equipment and software operate as expected once installed in your facility. This is not widely understood outside the biologics & healthcare industries and the costs often come as a surprise to many new owners as they are expensive, must be performed with approved procedures by professionals and, in some circumstances, by trained center staff.
□ YOU MUST TRAIN YOUR STAFF
It is not uncommon for new owners to assume that doctors and nurses do not require training. However, in an FDA regulated plasma center they not only require initial training, but they and ALL staff must be thoroughly trained and have proven competency in applicable SOPs. In addition, they must have regular, ongoing and annual training as well.