Consistent, effective, high-quality homeopathic products. That’s what our consumers want in each and every dose. Yet quality doesn’t happen by accident. Manufacturers must create it through process validation. Each manufacturer must ask themselves: Do I have scientific evidence that my (manufacturing) process is capable of reliably delivering quality product?
It’s important to note that process validation isn’t an option. It’s a requirement. Since homeopathic products are considered drugs by the U.S. Food and Drug Administration (FDA), they fall under the 2011 Guidance for Industry, Process Validation: General Principles and Practices.
What is Process Validation? Defining the Terms
First, to be clear, process validation is: The collection and evaluation of data, from the process design stage throughout commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
There are three crucial inputs that allow for the validation of a process:
Process Parameter (PP): A process variable that can be controlled and set to a specific value (e.g., temperature, pressure, pH, speed, RPM, time).
Critical Process Parameter (CPP): A process parameter that must be controlled within predefined limits to ensure the quality of the product.
Critical to Quality Attribute (CQA): Quality attributes (chemical, physical, biological, and microbiological) that must be verified to be within predefined limits to ensure the quality of the product.
If you believe that your equipment is “validated” but you have not defined CQAs or CPPs, there is no way to adequately control processes or conduct a legitimate and defendable process validation. Without validation, FDA may determine that your manufacturing is out of control, which can lead to 483s, warning letters, and even product recalls.
What is Required by FDA?
Among other important points found in FDA’s 2011 Process Validation: General Principles and Practices, the Guidance for Industry states that quality, safety, and efficacy should be designed or built into the product. Quality cannot be assured merely by in-process and finished-product inspection or testing. Furthermore, each step of a manufacturing process should be controlled to assure that the finished product meets all quality attributes including specifications.
The Guidance also outlines three stages of the process of validation. First is the Process Design Stage, which might include small-scale and commercial scale-studies to establish process. Next comes the Process Qualification Stage. This second phase includes the qualification and process-performance qualification of the facility, utilities, and equipment. Finally, during the Continued Process Verification Stage, manufacturers must monitor and collect information during the commercialization process as well as maintain continuous verification and process improvement.
As you might suspect, the concepts covered here represent just the tip of the iceberg when it comes to process validation. We urge you to thoroughly review and implement FDA guidance as well as invest in process validation in your facility if you haven’t already. The importance of quality cannot be understated. Consumers and our entire industry depend on it.
Further Reading from AAHP: