OBJECTIVE
To develop cost effective, efficient programs to validate the various processes associated with compounding medications.
BACKGROUND
The term validation means that a pharmacy has proven that the processes employed for compounding medications have been proven to:
- Create a consistent quality of product across lots and over time.
- Not negatively impact the medication.
There are a number of processes employed in compounding, including but not limited to, dissolution of raw material, mixing, sterilization, and filling. These various processes may be very different, given the type of form being compounded and if not validated, may result in significant and unpredictable variability in the compounded product. Validation can be a very confusing and expensive exercise if not done properly.
OUR APPROACH
To minimize the confusion and expense associated with implementing a validation program, DYNALABS will first work with you to assess the quality of product being produced by the processes currently employed by the pharmacy. If there are issues with the quality, DYNALABS then uses its’ extensive experience to identify the most likely step in the process causing the issue. We then suggest very specific improvements which may then be implemented and tested. Once the process is optimized, the improvement is by extension applied to all compounds utilizing that same process. By employing this approach to validation, only the steps in the process that are creating a problem are specifically tested. The remaining steps may be assumed to be valid if the product meets its label claims across lots and over time. The process for developing these programs is as follows:
- Identify the various forms compounded by the pharmacy
- Assess the quality of the medications compounded
- Where necessary, identify, implement, and test improvements
- Extend improvements to all compounds utilizing that process
IMPACT TO THE PHARMACY
- Minimize the cost of validating processes
- Minimize costs associated with reworks and discards
- Optimize time and costs associated with compounding processes
- Lower probability of litigation due to product not meeting label claims