This is a ready-to-use form for reviewing a supplier’s extractables data package for a single-use system component (a bag, tubing set, connector, filter, or sensor) before relying on it for component qualification. It answers a narrower question than the process-specific risk assessment: is the supplier’s own study adequate on its own terms, before you ask whether it clears your process. Replace every <<FILL: ...>> placeholder and attach it to the component’s supplier file. A worked filled specimen follows the template. Verify each cited standard against the current source before you rely on it.
Field table
| Field | Format | Required | Who completes | When |
|---|---|---|---|---|
| Component ID and description | Text | Yes | Supplier quality | At receipt of supplier data package |
| Supplier and manufacturing site | Text | Yes | Supplier quality | At receipt |
| Data package reference / report number | Text | Yes | Supplier quality | At receipt |
| Protocol basis (BioPhorum/BPOG standardized protocol, BPSA guidance, or supplier proprietary method) | Text | Yes | Supplier quality / E&L chemistry | At review |
| Extraction conditions used (solvents, temperature, time, surface-area-to-volume basis) | Text | Yes | E&L chemistry | At review |
| Analytical techniques used | Text | Yes | E&L chemistry | At review |
| Lot(s) and resin/material batch(es) covered | Text | Yes | Supplier quality | At review |
| Worst-case justification (contact time, temperature, surface area relative to your intended use) | Text | Yes | E&L chemistry | At review |
| Adequacy decision | Accept / Accept with conditions / Reject | Yes | E&L chemistry, QA | At review completion |
| Basis for decision | Text | Yes | E&L chemistry, QA | At review completion |
Instructions
- Confirm the component ID, supplier, and the data package reference before starting the technical review.
- Identify which standardized protocol, if any, the supplier used. A package generated to the BioPhorum (formerly BPOG) standardized extractables protocol or BPSA guidance carries more weight than a supplier-proprietary method with undisclosed conditions, because the standardized protocols define common extraction conditions and reporting that many users can rely on without a bespoke study.
- Check that the extraction conditions and analytical panel are consistent with what a controlled extraction study for this material class should include: solvents bracketing polarity, an exaggerated but justified temperature and time, and an orthogonal analytical panel (GC-MS, LC-MS, ICP-MS as applicable). A package that ran only one technique is a gap, not automatically a rejection, but the gap has to be named.
- Confirm the lot(s) and resin batch(es) the study covers are representative of what you will actually receive, and that the supplier has a change-notification commitment if the resin source, additive package, or manufacturing site changes.
- Assess worst-case fit: does the supplier’s study condition (contact time, temperature, surface area to volume) bound or exceed your intended process use. If your process is more severe than the supplier’s study conditions, the package alone is not adequate and a confirmatory process leachables study is required regardless of the decision below.
- Record the adequacy decision and route for QA countersignature. An “Accept with conditions” decision must name the condition (for example, a confirmatory process leachables study, or a request for updated data at the next resin lot change).
Acceptance criteria
- The protocol basis, extraction conditions, and analytical techniques are stated, not just referenced by a report number.
- The worst-case fit assessment explicitly compares the supplier’s study conditions to your actual process conditions.
- An “Accept” decision is supported by a stated basis; an “Accept with conditions” decision names the condition and its owner.
- The decision feeds the process-specific extractables and leachables risk assessment; it does not substitute for it.
Retention
Retain with the component’s supplier qualification file and reference it from the process-specific risk assessment. Retain for the life of the supplier relationship plus the record retention period defined in <<FILL: retention policy reference>>.
References
BioPhorum (formerly BPOG) standardized extractables protocol for single-use systems. BPSA (Bio-Process Systems Alliance) guidance on extractables and leachables for single-use systems. USP <1663>, Assessment of Extractables Associated with Pharmaceutical Packaging and Delivery Systems. See Extractables and Leachables and Supplier and Vendor Qualification.
Filled specimen
| Field | Entry |
|---|---|
| Component ID and description | Single-use bioreactor bag, 200 L, film assembly SU-BAG-200 |
| Supplier and site | <<FILL: supplier name>>, manufacturing site <<FILL: site>> |
| Data package reference | Supplier extractables report EXT-SUP-2026-008 |
| Protocol basis | BioPhorum standardized extractables protocol, aqueous and 50% ethanol extraction conditions |
| Extraction conditions | 40 degrees C, 24-hour and 7-day timepoints, surface-area-to-volume ratio matched to the 200 L bag geometry |
| Analytical techniques | GC-MS headspace and direct injection, LC-MS/HRMS, ICP-MS |
| Lots covered | Three resin lots across two manufacturing campaigns, 2025-2026 |
| Worst-case justification | Supplier study conditions (40 degrees C, 7 days) exceed the process’s actual contact profile (ambient temperature, 48-hour maximum hold), so the supplier data bounds the intended use |
| Adequacy decision | Accept with conditions |
| Basis for decision | Package is adequate on its own terms and bounds this process’s contact profile; condition: process-specific risk assessment RA-SUS-014 still required to confirm no downstream purification gap for the one flagged extractable near the process AET |
Interpretation: the supplier package itself was judged technically adequate (standardized protocol, orthogonal analytics, representative lots, conservative worst-case conditions), but adequacy of the supplier study does not by itself clear the component; the process-specific risk assessment is still the gating step before the component is released for use.
Common inspection findings this form prevents
- Relying on a supplier’s letter of guarantee with no documented review of the actual extraction conditions or analytical panel behind it.
- No record of whether the supplier’s study conditions actually bound the site’s real process conditions.
- A supplier resin or site change that occurs with no mechanism to learn about it, because the acceptance decision was never tied to a defined lot and change-notification commitment.
How to adapt this form
- Set the component and supplier package details.
- Work through the protocol-basis, extraction-conditions, and worst-case-fit questions against the actual supplier report, not a summary letter.
- Record the adequacy decision with its basis, and name any condition explicitly.
- Route to QA for countersignature and file with the supplier qualification record.
- Reference this form from the process-specific extractables and leachables risk assessment for the same component.