Documents to Request from Suppliers When Adopting Single-Use

Why Request Documents

For a single-use system (bags, tubing, filters and connectors that are used once and discarded, and their assemblies), material selection, assembly and sterilization take place at the supplier. Because the user cannot see these steps directly, the supporting evidence has to be confirmed through documents. EU GMP Annex 1 (revised 2022, in operation from August 25, 2023) states that supplier assessment is critical to the selection and use of single-use systems, and requires that, for sterilized products, sterility assurance be verified as part of supplier qualification and evidence of sterilization be checked at every receipt. [1][2]

Documents to Request and What They Mean

Reading Extractables Data

• USP <665> is the standard for evaluating plastic components used in the manufacture of pharmaceuticals, and it became official on May 1, 2026. It classifies risk as low, moderate or high to set the scope of testing, and <1665> describes the framework for that risk assessment. [3][4][5][6]
• The BioPhorum protocol is an industry standard test method, a 2020 revision of the 2014 edition, and is not a regulatory document. [4][7]
• Supplier data are an input to the user's risk assessment and do not replace the assessment. Annex 1 also requires an evaluation, for each component, of whether the extractables data can be applied to your own process. [1][4]
• ICH Q3E (extractables and leachables), an internationally harmonized guideline, is at the stage where a draft (Step 2b) was published in August 2025. [17][18]

What to Check After Receipt

• At receipt, check and record the outer packaging, labels and accompanying documents (certificate of conformance, evidence of sterilization). [1]
• Check whether the test conditions (solvent, temperature, contact time) represent your own process. [1][19]
• Link change notifications to your own change control procedure. [13][19]

Sources