Processes Requiring Compliance to Regulations
-
What if you have a packaging line that is generating units of product for customers?
Your validation effort would start with an installation qualification (IQ) that would verify you have the right equipment, its base functionality works including software, and there are support systems to keep it in good operating condition. The IQ would be followed by operation and performance qualification (OQ/PQ) that would show the process generates acceptable products throughout its operating settings.
-
What if your product requires mixing or blending before packaging?
Your validation effort would still start with IQ for the equipment. Because the material is not yet separated into units, a process performance qualification (PPQ) would be needed for overall uniformity. Equipment that is used for multiple products that can interfere with each other’s performance requires cleaning validation to show that residue removal is effective. Products that are susceptible to environmental contamination require qualification of prevention and reduction measures.
-
What if other processes are needed to support the manufacturing of the product?
Temperature-controlled equipment starts validation with IQ with additional qualifications to show uniformity throughout the chamber. Product performance testing can include IQ for instruments with additional qualifications for accuracy and precision of the test method. Software used to make decisions or generate documents can include qualification of the hardware, software installation, functions, interface, and document accuracy.
-
What if a facility needs to maintain validation records for more than one project?
A Validation Master Plan provides guidance for validation expectations within the facility. A validation policy and associated templates keep consistency between projects. Training to the policy and templates builds skills among personnel.
Inquiry Form
Are you still thinking about how to bring your processes into compliance? Thank you for your consideration in meeting your validation consulting needs with Brayearst.
Please provide your contact information and any details you’d like to share for us to move forward with your project.
Are you ready to invest in your business to satisfy regulatory requirements?
Once you've sent this form, remember to check your email, including any junk or spam folders, for a follow-up message to prepare for our initial consultation. Looking forward to hearing from you!