This is a ready-to-use equipment and facility equivalence assessment for a technology transfer. Its job is to make sure no difference between the sending and receiving unit goes unassessed. For each unit operation it forces a documented decision (immaterial, manageable, or needs a study) on every difference, and it will not let a “needs study” item stay open past the point where demo batches start. Replace every <<FILL: ...>> placeholder with your own specifics, set your document numbers and dates, and route it through document control. A worked filled specimen follows the template. This is general guidance to adapt and verify, not legal or regulatory advice; confirm each cited regulation against the current source before you rely on it.
Document control header
| Field | Entry |
|---|---|
| Document title | Equipment and Facility Equivalence Assessment |
| Document number | <<FILL: ID, e.g. EA-TT-004-01>> |
| Version | <<FILL: version>> |
| Effective / assessment date | <<FILL: date>> |
| Linked transfer protocol | <<FILL: protocol number>> |
| Sending unit | <<FILL: site, building, room/suite>> |
| Receiving unit | <<FILL: site, building, room/suite>> |
| Assessment owner | <<FILL: role, e.g. Process SME / MSAT>> |
1. Purpose
This assessment compares, unit operation by unit operation and system by system, the equipment and facility the process was validated on at the sending unit against what the receiving unit will actually use. Every difference is classified and, where it is not immaterial, closed with a control or a study before the difference is allowed to reach a demo batch unmanaged. A qualification certificate for the receiving equipment is not, on its own, evidence of equivalence; equipment can be fully qualified against its own specification and still be the wrong shape, volume, or capacity for this product.
2. Scope
List every unit operation, room, and shared/critical utility system in scope for this transfer.
| In scope | <<FILL: list unit operations, e.g. dispensing, blending, granulation, drying, compression, coating, filling, lyophilization, purification, etc.>> |
|---|---|
| Rooms / classified areas | <<FILL>> |
| Shared utility systems | <<FILL: WFI, clean steam, HVAC, compressed gases, CIP/SIP, etc.>> |
| Explicitly out of scope | <<FILL: with rationale>> |
3. Methodology
For each row, identify the parameters that plausibly drive the relevant CQA or CPP (not every parameter the equipment has, only the ones that matter to this product), compare sending versus receiving, and classify:
| Classification | Meaning | Required closure |
|---|---|---|
| (a) Immaterial | The difference cannot plausibly affect the CQA/CPP | A one-line rationale is sufficient; no further action |
| (b) Manageable | The difference can be controlled by adjusting a parameter within the established design space or control strategy | Document the adjusted parameter and how it will be confirmed (typically a demo-batch endpoint) |
| (c) Needs a study | The difference is a real, unquantified risk | A dedicated study (bridging, scale-down, extractables/leachables, or equivalent) closed before the difference is allowed into a demo batch unmanaged |
No row may be left unclassified, and no (c) row may remain open when demo batches begin.
4. Equipment equivalence table
| Unit operation | Parameter driving the CQA/CPP | Sending site | Receiving site | Classification (a/b/c) | Control / closure evidence | Status |
|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL: Open/Closed>> |
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
5. Facility and utilities equivalence table
Facility fit is a separate dimension from equipment fit; a room can be the right classification and still have an adjacency, airflow, or utility difference that matters, especially for sterile and biologics products.
| Element | Parameter | Sending site | Receiving site | Classification (a/b/c) | Control / closure evidence | Status |
|---|---|---|---|---|---|---|
| Room classification | <<FILL: ISO/EU grade>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Adjacency / material and personnel flow | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Water system (WFI / purified water) | <<FILL: quality, generation method>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Clean steam | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Environmental monitoring program | <<FILL: alert/action levels, sampling locations>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
6. Single-use system supplement (biologics and cell/gene therapy)
Complete this section only when a unit operation uses a single-use, pre-sterilized disposable assembly. The comparison is componentry and supply-chain equivalence, not fixed-tank equivalence.
| Element | Sending site | Receiving site | Classification (a/b/c) | Control / closure evidence | Status |
|---|---|---|---|---|---|
| Assembly manufacturer, part number, gamma-dose spec | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL: identical assembly, or extractables/leachables and process-fit bridging per USP <665>/<1665>>> | <<FILL>> |
| Mixing time, gas transfer / kLa, shear at working volume | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Vendor change-notification agreement in place at receiving site | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
7. Acceptance criteria for closure
This assessment is complete and ready to support demo batches only when: every row in sections 4, 5, and (if applicable) 6 is classified; no (c) row remains open; every (b) row states the specific control and how it will be confirmed at the receiving unit; and the assessment owner and both units’ process SMEs have signed. A table of “sending versus receiving” with descriptions but no classification and no closure evidence does not meet this bar.
8. Roles
| Role | Responsibility |
|---|---|
| Process SME / MSAT (assessment owner) | Identifies the parameters that drive each CQA/CPP, performs the comparison, proposes classification |
| Engineering / facilities | Confirms facility and utility data are accurate and current |
| Analytical SME (QC) | Confirms analytical-equipment equivalence feeds the analytical transfer risk assessment, not just this document |
| Quality Assurance (both units) | Reviews classifications for consistency and rigor, approves closure, blocks demo batches on any open (c) item |
9. References
ICH Q9(R1), Quality Risk Management. ICH Q8(R2), Pharmaceutical Development (critical process parameters and design space). WHO Technical Report Series, No. 961, 2011, Annex 7, WHO guidelines on transfer of technology in pharmaceutical manufacturing. USP General Chapter <665>, Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products, and General Chapter <1665> (single-use system supplement, section 6). EU GMP Chapter 3 (Premises and Equipment) and Annex 1 (for sterile products).
Confirm the current version and clause numbers of each reference before issue.
10. Approval
| Role | Name | Signature | Date |
|---|---|---|---|
| Assessment owner | <<FILL>> | ||
| Sending-unit process SME | <<FILL>> | ||
| Receiving-unit process SME | <<FILL>> | ||
| Quality Assurance | <<FILL>> |
Filled specimen
Illustrative, for a high-shear wet granulation step moving from a 65 L development scale to a 150 L commercial scale at a new receiving site.
Equipment equivalence table (excerpt):
| Unit operation | Parameter | Sending site | Receiving site | Classification | Control / closure evidence | Status |
|---|---|---|---|---|---|---|
| Granulation | Bowl working volume | 65 L | 150 L | (c) Needs a study | Impeller/chopper speed scaling study; endpoint re-established and confirmed by 2 demo batches | Closed, demo batches DB-01/DB-02 both within range |
| Granulation | Impeller geometry | 3-blade | 3-blade | (a) Immaterial | Identical geometry, no rationale needed beyond identity | Closed |
| Granulation | Spray nozzle configuration | 1 nozzle | 2 nozzles | (c) Needs a study | Liquid addition rate matched per kg product; power/torque endpoint monitored during scaling study | Closed, demo batch DB-01 |
| Drying | Fluid bed capacity | 4 kg | 9 kg | (b) Manageable | Inlet temperature and product temperature profile matched within the established design space; confirmed by demo-batch LOD result | Closed, demo batch DB-01, LOD 1.8% vs limit 2.5% |
Facility and utilities table (excerpt):
| Element | Sending site | Receiving site | Classification | Control / closure evidence | Status |
|---|---|---|---|---|---|
| Room classification | ISO 8 (Grade D equivalent) | ISO 8 (Grade D equivalent) | (a) Immaterial | Same classification, both qualified | Closed |
| Water system | Purified water, distillation | Purified water, reverse osmosis/electrodeionization | (b) Manageable | Receiving system’s validated quality attributes confirmed to meet the same specification; no product-contact use, low risk | Closed |
Conclusion: No (c) row remains open. Two (b) rows required demo-batch confirmation, both closed with data within range. Assessment supports proceeding to PPQ per the linked transfer protocol.
Common inspection findings this assessment prevents
- A “sending versus receiving” equipment table that lists differences but never classifies or closes them, so demo batches proceed on unassessed risk.
- A fully qualified receiving-site instrument or vessel assumed equivalent because it passed its own IQ/OQ, without any comparison to what the process actually needs.
- Facility and utility differences overlooked because the assessment only covered equipment, not the room and systems around it.
- Single-use system component changes at the vendor that neither site was aware of, discovered only when a batch behaves differently.
- (c) classified items still open when PPQ starts, with no record of why they were allowed to proceed unclosed.
How to adapt this assessment
- Set your document number and link it explicitly to your transfer protocol and to the technology transfer risk assessment that scoped it.
- List only the unit operations and parameters genuinely relevant to your product; do not reuse the specimen’s granulation example if your process is different.
- Complete section 6 only for single-use unit operations; delete it if the process is entirely fixed-vessel.
- Route closure evidence (studies, demo-batch results) as attachments or cross-references, not narrative summaries with no traceable source.
- Confirm every regulation in section 9 against the current published version before issue.