Designing a Quality Management System
CSP Quality Management - The Dilemma
In normal compounding there are no batches or statistical models for justification of sampling results; thus no genuine quality assurance is possible using the classical manufacturing quality models. Yet, the pharmacy community is committed to assuring and improving the quality of CSPs.
Quality Control requires pre-release testing of a statistically significant sample from a batch to prove the quality of the batch. Quality Assurance requires statistically significant testing of the processes and systems by which a batch is produced to assure the quality of the end-product.
A batch can be defined as a distinct, ordered set of operations performed upon a specific quantity of input materials over a finite period of time using one or more pieces of equipment to produce a specific quantity of output. The assumption is that, if preparation conditions remain the same as validation conditions, the items produced will have very similar characteristics. It follows that testing performed upon a sample of these items will be representative of the qualities of all of the items in the batch. Most CSPs do not meet this definition. Even those items that are referred to as ‘batch prepared’ in the pharmacy setting usually are not genuinely a batch, because each item is discreetly produced manually by an operator rather than a machine.
In an effort to achieve the desired assurance of the safety, accuracy, purity, and identity of CSPs, pharmacy has, quite intuitively, looked to the pharmaceutical manufacturing industry for models -- but the models don't fit. To be sure, there is a great deal to be learned from the methods employed by manufacturers, but the quality management models cannot be directly applied to the CSP process from these non-dynamic, non-extemporaneous processes.
The Craftsmanship Model for CSP Quality Management
A craftsmanship approach to quality management incorporates many of the features of quality control and quality assurance, including:
- a definition of quality
- measures of quality
- a means of accepting or rejecting a product, preparation, or operational conditions
- definition and documentation of all critical activities and conditions
Necessary documentation of process parameters is most efficiently carried out by use of a data management system. The VALITEQ Data Management Software maintains critical documentation and also provides automatic comparison of data to acceptance standards.
The craftsmanship approach differs from other quality management systems in that the emphasis is not on control of the product (QC) or the system (QA) (although both of these are important and integral) but on the skills and integrity of the individually recognized Craftsperson. For individually or discreetly prepared items, this is the single most important factor effecting the quality of the compounded sterile preparation.
The craftsperson needs the following things to be successful:
- personal responsibility
- appropriate workspace and equipment
- quality materials
- cohesive team support
- recognition of status and accomplishments
The comprehensive training materials available from VALITEQ not only provide the knowledge and skills required to produce consistently high quality CSPs, they imbue the practitioner with an essential sense of personal responsibility and of team spirit, which are all-important to the success of the CSP process.
View educational tools.
ACPE continuing education credits can be obtained which also provide personnel recognition of their accomplishments. To assure and document the ongoing compliance of operative techniques and the work environment with aseptic processing standards, Lab Safety offers USP <797>-compliant SteriTEQ™, SteriQUOT™, ThioTEQ™, and ThioQUOT™ pharmacy-friendly end-product testing and monitoring systems.
View products for end-product testing and monitoring.
To assure and document compliance of the compounding and support environments, Lab Safety offers the EnviroAssay™ Environmental Monitoring Kits facilitating USP <797>-compliant active sampling of critical and support areas for airborne viable and non-viable particulates and surface microbial contamination.
View products for environmental testing and monitoring.
Use these principles to control contamination at your facility:
Minimize Contamination Potential
The fewer potential contaminants the less likely contamination will occur. This is true for all types of contaminants, including particles, drug residues, and microbes. The following help reduce contamination potential:
- Meticulous hygiene
- Rigorous and frequent cleaning and disinfection
Prevent Contaminant Transfer
The number one source of contamination in the CSP process cannot be eliminated. This is the operator, who is a veritable microbe factory. Gowning, including hair covers, face masks, jackets or suits, shoe covers, and, most especially, frequently disinfected gloves provide a barrier to contaminant transfer.
Prevent Contamination Events
Not all potential contaminants can be eliminated or contained. The third element of contamination control is planned avoidance of practices and conditions that can introduce contaminants into CSPs, known as the aseptic technique.
It is necessary to periodically test and monitor all components of the CSP system, including the proper functioning of equipment and the skills of personnel. However, annual or semi-annual monitoring of all parameters will not assure ongoing proper functioning of equipment or routine compliance of personnel. Many of the routine process parameters of the CSP process will need to be monitored on a per shift, daily, weekly, and monthly basis and documented to assure ongoing compliance with process and product specifications. Monitoring data should be quickly and accurately gathered and analyzed for monitoring values or trends that indicate any deterioration of the process.
Lab Safety facilitates inexpensive identification, control, and documentation of your routine monitoring tasks through the use of the Data Management System (DMS), version 2.0.Monitoring Program