As Compound Preferred expands its IV vitamin therapy product line, a process must be followed to stay consistent with a confidence in quality mantra, and FDA regulations.
Rob Myers, Operations Manager and Pharmacist in Charge
To create a new compound preparation, we must first make the following assessments, per regulatory and institutional standards.
- Check appropriate databases to ensure no comparable commercial (approved) product is available.
- Determine from credible professional literature that there appears to be an appropriate use of the preparation.
- Determine whether the compounded preparation would represent an acceptable benefit-risk ratio and whether any known or suspected patient safety issues are associated with the use of the preparation.
- Determine the best estimate of how often and how much the new preparation might be used.
- Based on available data, determine a suitable formulation for the product.
- The product must be chemically, microbially, and physically stable and not cause irritation to a patient.
- Be certain that the preparation is not a copy of comparable existing formulations.
- Perform initial studies to determine a feasible formulation process.
- Determine a suitable batch size for the product.
- Determine if the new preparation requires a purchase or installation of additional equipment.
- Verify if current validated processes can make the product or if a new process validation is needed.
- Prepare an appropriate development batch to be sent for analytical method development.
Casey Hunter, Quality Assurance and Regulatory Affairs Manager
What does it take to research and develop new products from a quality assurance perspective?
There are two different approaches to researching and developing a pharmaceutical product. I will speak to the development side. Some organizations rely on the old “wild, wild west” adage. By this, I mean Quality Assurance is not involved until a development batch is made; change controls are not utilized for development. This approach is used because nothing is changing; it is new. Some organizations will utilize a change control system because it is changing from nothing to something. There is a vast difference in requirements for large-scale pharmaceutical manufacturers seeking an NDA (New Drug Application), ANDA (Abbreviated New Drug Application), NTE (New Therapeutic Entity), or similar, and requirements for 503B outsourcing facilities.
At Compound Preferred, we have elected to use a change control process because 21 CFR 210 – 211 requires the quality control unit to review and approve changes. This allows us to plan, document, and record everything surrounding the development of a new product. The quality unit is part of the process upfront. Product specifications, CQAs (Critical Quality Attributes), and production CPPs (Critical Process Parameters) are determined in advance to ensure quality by design.
After careful planning, development batches are made and subjected to all testing requirements of commercially distributed products; however, the development batches are not released for distribution. A commercial product can be made once a quality new product has been developed and all testing has passed predetermined specifications. All required release testing is performed again on the first production lot, and passing results are required prior to commercial distribution. This is a simplified description and is by no means all-inclusive of controls in place for new products.
In conclusion, we are confident in our new products being developed and tested and are excited for the need they will fill for our partners.