Most life science companies and many high-tech organizations know that GxPs (i.e. GLPs, GCPs, GMPs, etc.) have been designed by the FDA as quality requirements/guidelines for product development and production. To meet GxP requirements, additional regulatory compliance standards and internal company rules, life science companies have developed processes that often “get by” but remain somewhat vague in terms of definition.
How should theses processes be defined and monitored?
Some professionals might say that the processes mentioned above would be referred to as quality control and quality assurance processes but it is important to remember that the term quality control is more readily applied to manufacturing processes than it is to GxP, compliance or even internal rules processes, which are spread more carefully across various stages of a product’s development. The term quality assurance on the other hand seems to apply better than the term quality control, though even the term quality assurance isn’t quite appropriate since it is more of a blanket term for the processes that control quality control tasks and procedures.
6 States of Product Development: Why does quality control only apply to 1?
In short, all of the processes mentioned above, (i.e. GxP requirements, additional regulatory compliance standards and internal company rules) remain nameless and yet still seem to situate themselves comfortably within 6 stages of product development:
• Concept
• Feasibility
• Definition
• Development (includes manufacturing)
• Commercialization
• Market
Limited Quality Control: Is the current focus too narrow?
The interesting aspect of identifying the stages of a product’s development is that most of these stages remain mostly unaffected by current company quality controls. For instance, pre-manufacturing stages of a product’s conception, feasibility diagnosis, and definition as well as post-manufacturing phases such as commercialization and marketing are often ignored as processes that would deem any sort of streamlined quality controls that could be connected to the subsequent quality controls mandated during manufacturing procedures. Wouldn’t it be safe to assume however that if quality controls were implemented within every stage of a product’s development phase and connected with each other that the manufacturing stage itself would be a simpler “cat to skin.” Even technology, such as quality control software solutions, could be magnified to encompass the determined quality control processes of an entire company.
GxP Software Solutions: Magnifying Quality Controls
For companies that are interested in broadening their quality control horizons, consider a GxP software solution or another software solution that automates and helps to streamline all phases of GxP requirements and connect processes within a company. Within this type of software suite, companies should consider searching for the following connectable solutions:
Document Control
If any one aspect of quality and compliance should be streamlined and maintained throughout the lifespan of a product it would be documentation. Every stage of production (concept, feasibility, definition, development, commercialization, market) requires some form of documentation control whether the documentation is quality or compliance related. Electronic documentation controlled effectively during the concept and feasibility phases can often prevent errors during subsequent phases and if erros are not prevented, then at the very least strings of documentation are more easily edited when documentation is tracked and controlled electronically.
Customer Complaints Management
Customer complaints, though often unpleasant are actually sheep in wolves clothing or in other words, indicators of a company’s potential for improvement. Customer complaints management software is readily available in fact, but professionals shouldn’t search for a customer complaints solution that is an entity in itself but one that can trigger CAPA investigations, subsequent change control orders, subsequent trainings, etc.
Audit Control
Since internal and external audits are an inevitable part of maintaining quality and meeting regulatory standards, search for an audit control solution that can be triggered by deviations or nonconformance data results. Also, search for an audit solution that can trigger change control orders and subsequent employee guidance and training exams.
Conclusion
Providing connections and control across the phases of product’s phase of development may well be the next step for life science company management.
Marci Crane is a copywriter with MasterControl in Salt Lake City, Utah. For more information in regards to quality control solutions, please feel free to contact a MasterControl representative.
