Validation guides and documentation
Material validation and qualification of single-use components is now a critical part in the assessment of the suitability of drug manufacturing equipment. At Watson-Marlow Fluid Technology Group (WMFTG), we partner with our global biotechnology and pharmaceutical customers to ensure they receive appropriate technical and compliance data, helping them to manufacture safe medicines in the most consistent way possible.
Our fluid path technology is available with the most up-to-date and industry-leading validation and qualification data possible helping our customers to achieve GMP requirements. As the requirements for single-use equipment is constantly evolving, our in-house validation experts constantly monitor regulatory and industry expectations, ensuring our compliance data is reflective of current market expectations and regulatory standards.
Product technical data and test methodologies as detailed by global pharmacopoeias including USP, EP and international standards are contained within our validation documentation. Validation test data and compliance information are listed in our standard three-tier document structure consisting of a validation summary guide, a compliance guide listing regulatory material statements and a full validation guide.
Validation summary guides are available to all customers looking for more detail about our products. Pre-approved customers can download full validation guides and compliance guides that allow full access to unabridged and complete data and validation test reports, ready to include in their risk assessments and regulatory filings.
Certificates of conformance
You can request a copy of a product certificate of conformance with the following link.
Learn about our test methodologies and technical data by downloading one of our product summary...
View documentation detailing compliance statements that apply to our fluid path products
Complete a request form to access compliance guides and full validation guides including test...
White papers, industry tools and other technical resources