To develop cost effective, efficient programs to validate the performance of specific pieces of equipment used for making compounded medications.
Equipment used for compounding medication needs to be validated to be operating properly. There are three critical activities associated with equipment validation:
- Installation Qualification: Was the piece of equipment install properly? For example, are the utilities and environmental factors appropriate for the proper operation of the piece of equipment?
- Operational Qualification: Is the piece of equipment operating in a way in which it was designed? For example, does it start, run, and shut down properly? Do lights, bells, and whistles activate when they are supposed to?
- Performance Qualification: Does the piece of equipment consistently produce the quality of product for which it was designed?
As with anything, validating the equipment is working properly may be a confusing and expensive exercise, if not done properly.
DYNALABS focuses on helping with the Performance Qualification aspect of Equipment Validation. Data created during the Process and Product Validation may be used in part for the Performance Qualification of the equipment as well. If there are issues with the equipment during process validation, these issues will be addressed with solutions. The process for developing a Performance Qualification Program is as follows:
- Identify the various pieces of equipment used for compounding
- Determine the critical pieces of equipment requiring validation
- Installation and Operation qualification status
- Establish plan for Performance Qualification of critical equipment
IMPACT TO THE PHARMACY
- Minimize the cost of equipment validation
- Minimize costs associated with reworks and discards
- Optimize time and costs associated with equipment failures
- Lower probability of litigation due to product not meeting label claims