This is a ready-to-use checklist for qualifying a new, or requalifying an existing, supplier of an active pharmaceutical ingredient starting material or a critical raw material with process-relevant impact. It assumes the starting material designation itself (where GMP begins in the synthesis route) has already been justified elsewhere; see the API starting material selection and justification report for that separate CMC decision. This checklist covers qualifying the organization that manufactures the material. Replace every <<FILL: ...>> placeholder with your own specifics. A worked filled specimen follows. Verify each cited regulation against the current published source before you rely on it. This template is an educational reference for you to adapt to your own quality system, products, and regulatory context; it is not legal, regulatory, or professional advice.
Administrative details
| Field | Entry |
|---|---|
| Supplier name / site | <<FILL>> |
| Material and grade | <<FILL>> |
| Designated starting material step | <<FILL: reference the CMC justification document number>> |
| Reviewer | <<FILL: name, role>> |
| Review date | <<FILL>> |
Checklist
Mark each item Pass, Fail, or Not Applicable. Note evidence reviewed for every Pass, and open action for every Fail.
| # | Item | Evidence to ask for | Pass / Fail / NA | Notes |
|---|---|---|---|---|
| 1 | Starting material designation and specification are documented and referenced | CMC justification document, agreed specification | <<FILL>> | <<FILL>> |
| 2 | Supplier’s public regulatory history screened before proceeding | Warning letter database, import alert list, prior inspection outcomes | <<FILL>> | <<FILL>> |
| 3 | Current GMP certificate or equivalent inspection outcome on file, scope confirmed to cover this material | Certificate, EIR, or inspection summary | <<FILL>> | <<FILL>> |
| 4 | Quality manual and quality system documentation reviewed | Quality manual, relevant SOP index | <<FILL>> | <<FILL>> |
| 5 | Route summary sufficient to confirm process consistency and control obtained, scoped per the quality agreement | Route summary, process description | <<FILL>> | <<FILL>> |
| 6 | Audit (on-site or justified remote) scope reached the reaction and purification steps producing the starting material, not only the general quality system | Audit report, agenda | <<FILL>> | <<FILL>> |
| 7 | Change control on the route and on critical reagents reviewed | Change control procedure, recent change examples | <<FILL>> | <<FILL>> |
| 8 | Supplier’s own genotoxic and N-nitrosamine impurity risk assessment for the route reviewed | Risk assessment document | <<FILL>> | <<FILL>> |
| 9 | Reference standard qualification and traceability confirmed | Reference standard certificate, traceability record | <<FILL>> | <<FILL>> |
| 10 | Batch documentation practices reviewed for completeness and contemporaneous recording | Sample batch record (redacted as needed) | <<FILL>> | <<FILL>> |
| 11 | Representative lot(s) sampled and tested against specification | Test results, lot numbers | <<FILL>> | <<FILL>> |
| 12 | Bridging or comparability check run against a prior qualified or process-validation lot, where one exists | Comparability data | <<FILL>> | <<FILL>> |
| 13 | Quality agreement executed or updated, naming the route, the starting material step, critical reagents, and the site in the change-notification clause | Executed quality agreement | <<FILL>> | <<FILL>> |
| 14 | Data integrity controls in the supplier’s laboratory confirmed (audit trail, access control) | Audit observations, system description | <<FILL>> | <<FILL>> |
| 15 | AVL entry drafted with the starting material scope stated explicitly (step, grade, site) | Draft AVL row | <<FILL>> | <<FILL>> |
| 16 | QA approval obtained and dated | Approval signature | <<FILL>> | <<FILL>> |
Disposition
| Field | Entry |
|---|---|
| Total items Pass | <<FILL>> |
| Total items Fail | <<FILL>> |
| Open actions and target dates | <<FILL>> |
| Overall recommendation | <<FILL: Approve / Approve with conditions / Do not approve>> |
References
ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (own-wording summary; consult the source guideline directly for exact text). ICH Q11, Development and Manufacture of Drug Substances, for starting material selection principles. 21 CFR 211.84, testing and approval or rejection of components, drug product containers, and closures. EMA/CHMP Guideline on the chemistry of active substances, finalized March 2026, effective 1 September 2026, for current expectations on active substance chemistry documentation including starting materials (section 4.2.3) and N-nitrosamine impurities. This is a chemistry documentation guideline; use it to check documentation content, not as an audit-procedure source. EudraLex Volume 4, Chapter 5, evaluation and approval of suppliers.
Confirm the current version, clause numbers, and effective dates of each reference before issue.
Signoff
| Role | Name | Signature | Date |
|---|---|---|---|
| Reviewer / auditor | <<FILL>> | ||
| CMC or regulatory affairs (starting material designation confirmed) | <<FILL>> | ||
| QA approver | <<FILL>> |
Filled specimen
A worked qualification for a new supplier of an API starting material used in a small-molecule synthesis route.
| Field | Entry |
|---|---|
| Supplier name / site | Highfield Specialty Chemicals, Site 3 (illustrative name) |
| Material and grade | 4-substituted intermediate, GMP grade, designated starting material |
| Designated starting material step | CMC-SM-2026-007 |
| Reviewer | A. Khan, Lead Auditor |
| Review date | 2026-08-21 |
Selected items from the worked review:
| # | Item | Pass / Fail / NA | Notes |
|---|---|---|---|
| 3 | Current GMP certificate, scope confirmed | Pass | Certificate covers this intermediate by name and grade, issued by national authority, valid through 2027 |
| 6 | Audit reached reaction and purification steps | Pass | On-site audit walked the two-step synthesis producing the starting material, observed in-process sampling |
| 8 | Nitrosamine risk assessment reviewed | Pass | Supplier’s route assessment identifies no nitrosamine-forming conditions in the two steps preceding the starting material; documentation format consistent with current EU chemistry documentation expectations |
| 12 | Bridging comparability | Pass | Three qualification lots compared against the lot used in the buyer’s process validation batch; results within historical range |
| 13 | Quality agreement change-notification clause | Pass | Clause names the two-step route, the named starting material step, and the single manufacturing site; any route or site change requires 90-day advance notice |
Overall recommendation: Approve. AVL entry drafted naming the starting material step and site explicitly; next scheduled review in 24 months, risk-adjusted per the supplier’s Tier 1 classification.
Common inspection findings this checklist prevents
- A starting material supplier audited as if it were a general materials vendor, never reaching the actual reaction and purification steps.
- A change-notification clause that references “material changes” generically, with no route, step, or site named.
- No representative lot testing or bridging comparison performed before approval.
- The starting material justification (a CMC document) mistaken for supplier qualification (an operational activity), leaving one of the two undone.
How to adapt this checklist
- Confirm the starting material designation exists before starting this checklist; if it does not, that CMC decision has to happen first.
- Adjust the audit scope items to the specific chemistry involved; not every route raises the same impurity or reprocessing questions.
- Link the disposition outcome to the supplier risk tier classification and the approved vendor list register so the qualification result is reflected in both records.