How to use this document
Copy the template below into your quality system. Replace every <<FILL: ...>> placeholder with your company, system, and process specifics, then route it through your own document control, review, and approval. The filled specimen shows one worked example; adapt the numbers and scope to your operation and verify each cited regulation or standard against the current source before you rely on it.
This is a generic, originally worded starting point. It contains no confidential, proprietary, or employer material, it is drafted with AI assistance and reviewed, it is not legal or compliance advice, and adopting it does not by itself create or prove compliance. See the Disclaimer and Terms.
This is a ready-to-use equivalency assessment for the raw materials, single-use assemblies, and automation or control system logic a technology transfer moves alongside the process itself. It exists because a transfer risk assessment scoped around unit operations and equipment often treats “same specification” or “same part number” as sufficient, missing the attribute, lot-family, or logic difference that generates a deviation after PPQ has already started. Replace every <<FILL: ...>> placeholder with your own specifics and route it through your normal document control, review, and approval. A worked filled specimen follows. Verify each cited reference against the current source before you rely on it.
1. Purpose
This assessment compares, attribute by attribute rather than specification limit by specification limit, the raw materials and single-use components the receiving site has actually sourced against what the sending site qualified, and verifies that any migrated automation or control system logic is functionally and logically equivalent, before either is treated as a routine like-for-like substitution in the transfer.
2. Scope
3. Responsibilities
4. Raw material equivalency
Compare every attribute on both sites’ certificates of analysis, not only the attributes both certificates happen to share; an attribute reported by one supplier and silently absent from the other is itself a finding, not a pass by omission.
5. Single-use component equivalency
A matching part number is a starting point for the comparison, not the conclusion; confirm the actual assembly drawing and resin or film lot family behind it before calling two components equivalent. See filter validation for biologics and oligonucleotides for the same principle applied specifically to filter qualification.
6. Automation and control system equivalency
Any manually re-created recipe element gets an independent line-by-line review by someone who did not build the migrated logic, followed by a dry-run or factory acceptance test that exercises every interlock and alarm condition, not only the nominal batch path.
7. Residual risk acceptance
8. References
ICH Q9(R1), Quality Risk Management.
USP General Chapter <661>/<661.1>/<661.2>, Plastic Packaging Systems and Their Materials of Construction (extractables and leachables context).
Confirm the current version of each reference before issue.
9. Revision history
10. Approvals
Filled specimen
Extract from an example transfer of Acme Therapeutics’ ATX-207 autologous CAR-T process to a CDMO. Company, product, and numbers are illustrative.
Automation: the wash-step hold interlock, manually re-created on the receiving site’s platform, was independently reviewed line by line by a second automation engineer and caught a units transposition (90 minutes entered as 90 hours) before the dry run; corrected and re-reviewed, disposition closed with no further action.
The specimen shows the pattern the assessment exists to catch: a “same grade” raw material lacking a data point the process actually depends on, a “same part number” component sourced through a different channel with an unverified resin lot, and an automation error a completed-batch functional test would never have revealed.
Common inspection findings this assessment prevents
- A raw material accepted as equivalent because it meets the same specification, with no attribute-by-attribute comparison against what the process characterization data actually used.
- A single-use component treated as identical because the part number matches, with no check on the actual assembly drawing or resin/film lot family behind it.
- An automation recipe manually re-created with no independent review, verified only by a successful functional run of the normal batch path.
- No documented disposition or bridging study for a raw material or component difference that was identified but never formally closed.
How to adapt this assessment
- Set your document number, sites, and linked transfer plan and risk assessment numbers in the header.
- List every critical raw material and single-use component the process depends on, not only the ones that changed obviously.
- Require an attribute-by-attribute CoA comparison, not a specification-limit comparison, for every raw material row.
- Require an independent reviewer, not the person who built the recipe, to sign off on every automation migration row.
- Confirm every reference in section 8 against the current published version before issue.
