This is a ready-to-use report template. It is the document a reviewer or inspector actually asks for: not the individual extractables study, not the leachables study, but the single written conclusion that ties both together with the toxicological disposition of every identified compound and states, in one place, whether the product is safe with respect to extractables and leachables for its labeled shelf life and route. Replace every <<FILL: ...>> placeholder, attach the underlying study reports, and route it through document control for Toxicology and QA approval. A worked filled specimen follows the template. Verify each cited standard against the current source before you rely on it.
Control header
| Field | Entry |
|---|---|
| Report number | <<FILL: RPT-EL-ID>> |
| Product / system | <<FILL>> |
| Route of administration | <<FILL>> |
| Underlying studies referenced | <<FILL: extractables protocol/report number, leachables protocol/report number, risk assessment number>> |
| Prepared by / date | <<FILL>> |
| Reviewed by (Toxicology) / date | <<FILL>> |
| Approved by (QA) / date | <<FILL>> |
1. Purpose and scope
This report presents the extractables and leachables safety assessment for <<FILL: product/system>>, integrating the controlled extraction study, the leachables study on stability, the applicable safety thresholds, and the toxicological disposition of every compound identified at or above the analytical evaluation threshold (AET). It concludes whether the product is acceptable with respect to extractables and leachables for the labeled shelf life of <<FILL: shelf life>> under <<FILL: storage conditions and orientation>>.
2. Summary of the extractables study
| Item | Entry |
|---|---|
| Extractables protocol / report number | <<FILL>> |
| Materials studied | <<FILL: list of product-contact materials>> |
| Extraction conditions | <<FILL: solvents, temperature, time, surface-area-to-volume ratio>> |
| Analytical techniques used | <<FILL: e.g. GC-MS headspace and direct injection, LC-MS/HPLC-DAD-HRMS, ICP-MS>> |
| Number of extractables identified at or above the AET | <<FILL>> |
| Reference | USP <1663>, Assessment of Extractables Associated with Pharmaceutical Packaging and Delivery Systems |
3. Summary of the leachables study
| Item | Entry |
|---|---|
| Leachables protocol / report number | <<FILL>> |
| Study basis | <<FILL: actual product / validated simulant>> |
| Storage conditions and orientation | <<FILL>> |
| Timepoints tested | <<FILL: e.g. initial, 6mo, 12mo, 24mo, through shelf life>> |
| Targeted vs. non-targeted analysis | <<FILL>> |
| Number of leachables identified at or above the AET | <<FILL>> |
| Reference | USP <1664>, Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging and Delivery Systems |
4. Safety thresholds applied
| Item | Entry |
|---|---|
| Route | <<FILL>> |
| Applicable threshold source | <<FILL: PQRI OINDP (SCT 0.15 micrograms/day) / PQRI parenteral (SCT 1.5 micrograms/day) / structure-based case-by-case for ophthalmic>> |
| Safety Concern Threshold (SCT) | <<FILL>> |
| Qualification Threshold (QT) | <<FILL: e.g. 5 micrograms/day>> |
| Final AET applied (per the linked worksheet) | <<FILL>> |
5. Disposition of each identified compound
| Compound | Identified in (extractables/leachables) | Estimated daily exposure | Hazard-classified (Y/N) | Disposition | Basis |
|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL: below SCT, no further action / structure-based evaluation / toxicologically qualified / controlled to hazard-specific limit>> | <<FILL>> |
Add one row per compound identified at or above the AET in either study. A compound appearing in both the extractables and leachables studies is listed once, with its leachables exposure carried forward as the governing value.
6. Single-use system / process leachables (if applicable)
| Item | Entry |
|---|---|
| Process-contact materials assessed | <<FILL>> |
| Supplier extractables data source | <<FILL: BioPhorum/BPSA-protocol supplier data package reference>> |
| Process-specific risk assessment reference | <<FILL>> |
| Confirmatory process leachables study performed (Y/N) and reference | <<FILL>> |
7. Conclusion
<<FILL: written safety conclusion, e.g. "Based on the extractables and leachables studies referenced above, all identified compounds are either below the applicable Safety Concern Threshold or have been toxicologically qualified at their observed exposure. No identified compound exceeds its qualified safe level. [Product] is concluded to be acceptable with respect to extractables and leachables for its labeled shelf life of [X] under [storage conditions].">>
8. Deviations and open items
<<FILL: any deviation from the protocol, any compound still pending toxicological qualification, any interim rationale and its target closure date>>
Acceptance criteria
- Every compound identified at or above the AET in either study appears in the disposition table with a stated basis, not just a pass/fail flag.
- The safety threshold source and numbers are named explicitly and match the route.
- The conclusion is a single, unambiguous statement, not a restatement of the underlying data.
- Toxicology has reviewed and signed the disposition table and the conclusion; QA has approved the report.
- Any open item has an owner and a target date; the report does not conclude “acceptable” while a required qualification is still pending without a stated, risk-justified interim basis.
References
USP <1663> and <1664> (extractables and leachables assessment frameworks). PQRI safety threshold recommendations for OINDP and for parenteral drug products (ophthalmic products are worked case by case; PQRI has not recommended a specific numeric SCT for that route). ICH M7 and the nitrosamine guidances for hazard-specific limits on genotoxic-class compounds. See Extractables and Leachables for the underlying framework, the AET calculation, and the disposition decision path.
Confirm the current version of each recommendation before you rely on it.
Filled specimen
The following shows the report completed for an example prefilled syringe (parenteral route). Numbers are illustrative.
| Field | Entry |
|---|---|
| Product / system | Prefilled syringe, biologic drug product, elastomeric plunger stopper |
| Route | Parenteral (subcutaneous) |
| Threshold source | PQRI parenteral recommendation, 2022 |
| SCT | 1.5 micrograms/day |
| QT | 5 micrograms/day |
| Final AET | 0.6 micrograms/mL (per worksheet WS-EL-002) |
Disposition table (excerpt):
| Compound | Identified in | Estimated daily exposure | Hazard-classified | Disposition | Basis |
|---|---|---|---|---|---|
| Irganox 1010 degradant | Extractables and leachables | 0.4 micrograms/day | No | Below SCT, no further action | Estimated exposure below 1.5 micrograms/day SCT |
| Cyclic siloxane oligomer | Leachables only | 3.1 micrograms/day | No | Structure-based safety evaluation performed, qualified | Exposure between SCT and QT; structure-activity assessment found no alerting structure |
| N-nitrosamine trace | Extractables only, not confirmed in leachables | Not detected in leachables at or above AET | Yes (hazard class) | Controlled to ICH M7 acceptable intake; not present at a quantifiable level in the finished product | Hazard-classified compound overrides generic thresholds regardless of exposure |
Conclusion: Based on the extractables and leachables studies referenced above (protocols EXT-2026-014 and LEACH-2026-014), all compounds identified at or above the AET are either below the parenteral SCT of 1.5 micrograms/day, toxicologically qualified at their observed exposure, or, for the one hazard-classified compound identified only in the extractables study, confirmed not present in the leachables profile at a quantifiable level and controlled to its ICH M7 limit regardless. This product is concluded to be acceptable with respect to extractables and leachables for its labeled 24-month shelf life stored upright at 2-8 degrees C.
Common inspection findings this report prevents
- A submission that attaches the individual extractables and leachables study reports with no single, written safety conclusion tying them together.
- A disposition table that lists compounds and exposures but never states, per compound, which threshold rule applied and why.
- A conclusion that says “acceptable” while a toxicological qualification is still pending, with no visible interim basis.
How to adapt this report
- Set the report number and reference every underlying study, protocol, and worksheet by number.
- Populate the disposition table with every compound identified at or above the AET in either study; do not summarize by count only.
- Name the threshold source and numbers explicitly for the route; do not leave the reader to infer which PQRI recommendation applies.
- Write a single, unambiguous conclusion sentence, then list any open item separately with an owner and a date.
- Route for Toxicology review and QA approval before the conclusion is relied on in a submission or a change control record.