Commissioning, Qualification and Validation
Cleaning and Sterilization Validation
Commissioning, Qualification and Validation
- At QW, QW consulting experts provide process validation services for the design, qualification, and continued verification of manufacturing processes that help clients maintain quality and compliance for cGMP regulated products.
- QW global teams partner with you to ensure that each step of the validation process is properly mapped and executed. By working with QW process validation experts, you can deliver the documented evidence needed to guarantee to regulatory agencies that careful and systemic attention is applied and that QW product meets the necessary quality attributes.
- QW’s product lifecycle approach towards process validation in pharmaceuticals and biotech helps you deliver optimal product quality by identifying the presence and degree of process variation and the impact variation has on the process efficiency and product quality. Minimizing the variation reduces risks and ensures a robust process that reliably produces quality product.
- Defining the commercial manufacturing process based on knowledge gained during development and scale-up activities.
Cleaning and Sterilization Validation
- All manufacturers, hospitals, pharmacies, and medical device manufacturers require cleaning and sterilization. We partner with organizations to develop and implement continuously reliable and compliant validation programs that help clients successfully bring products to market.
- QW sterilization services include the physical (IQ and OQ) and microbiological inactivation (PQ) testing aspects for steam sterilization, dry heat, and vaporized hydrogen peroxide.
- QW cleaning services involve a defined clustering approach of products, protocols, defined assays and limits, protocol writing, in-test lab selection support, execution of testing support, and reporting that result in effective controls for limiting the bioburden