One of the biggest stumbling blocks standing between your firm and effective process validation is that the processes you seek to validate are neither static nor simple. Like most GxP-regulated firms, you maintain complex manufacturing processes that are subject to changing needs and demands. It's impossible to apply some catch-all validation standard to them all.
Fortunately, you can define transient processes to foster better understanding and improved validation.
What Are Critical Process Parameters?
Process parameters are essentially the measurable operating parameters for the units involved in your manufacturing process. For instance, the air temperature inside a pharmaceutical drying chamber and the fluid pressures inside pumps that process precursor chemicals all represent easily quantifiable figures that affect the end result of a fabrication technique. While most production facilities incorporate some form of measurement hardware that tracks such data, it's important that you take the additional step of contextualizing the information in terms of its importance to your end goals.
This is where critical process parameters (CPPs) come into play. Firms distinguish which process parameters are essential to the successful completion of their manufacturing processes within acceptable tolerances.
By defining the attributes that are most likely to impact quality attributes, it's possible to pick out pertinent facts from huge volumes of data without reducing your ability to track less-critical information as needed.
Analyzing these independent process parameters may also make it easier to deal with FDA Warning Letters. Organizations that have a better grasp of the most important aspects of their manufacturing procedures may be able to make effective changes and come up with workable CAPAs faster following the receipt of an official regulatory notice.
CPPs or CQAs?
CPPs are related to critical quality attributes (CQAs), but there's an important difference. CPPs are often used to derive quality attributes, but they apply to independent process parameters. CQAs, while equally important, are largely dependent on the processes used in manufacturing.
It's important to implement a quality system that incorporates quality attributes and process parameters alike. In order to understand the results of your CPP strategies and definitions, you must analyze pertinent physical, chemical, microbial and purity characteristics throughout the manufacturing process. CQAs are designed precisely for such detailed quantification.
Making Your Processes More Specific
Process robustness is a huge goal for those who manufacture pharmaceuticals, but it's impossible to achieve without concrete definitions. For instance, if you haven't quantified the aspects of your process by which you judge its efficacy, you can't really claim to be maintaining a robust implementation, no matter how well you regain your footing following setbacks.
Describing your processes in an explicit fashion gives you the power to maintain high efficiency in the face of potentially serious problems. When you have to deal with compliance issues using data-heavy strategies, like FMEA methodology, it helps to have an intimate understanding of which data you should be tracking as closely as possible. Without such an understanding, you'll find that basic process validation and deviation management become Herculean tasks.
GxP-CC consultants perform essential analysis services for firms that want to implement effective quality by design strategies. Discover how they can assist your organization's compliance and efficiency efforts by contacting them soon.