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Examples02 — Cross edition regulatory

Example 02: Cross-edition comparison supporting a regulatory submission

Scenario: a process engineer at a small-molecule pharmaceutical sponsor is preparing a CMC supplement for a regulatory submission. The submission switches a tablet line from batch to continuous direct compression. The relevant verification-of-continuous-manufacturing standard has just gone through a major edition revision.

Tools exercised: list_changes, resolve_reference (the second call surfaces the cross-publisher pointer case).

Standard (fictional): TMF-3050, Standard Guide for Verification of Continuous Pharmaceutical Manufacturing Systems. Comparison between editions 2023 and 2026.

Engineering intent: regulatory-submission (5).

Deliverable type: submitted-to-regulator (4).

Requester authority: organization-licensee (1). Regulatory submissions are issued by the firm, not by the individual engineer.

CLASP version: 0.1.

Language: canonical en; AI System declares preferred_languages: ["en"]. The regulatory incorporation is annotated with the transition-window fields and the BPEC pointer in Step 5 closes the loop with the BPEC discoverability catalog example.

Engineering context

The sponsor’s existing validation procedures were qualified against TMF-3050-2023, and the regulator’s reviewer guidance, last updated in 2024, references the 2023 edition by name. TMF-3050-2026 is now in force and the sponsor needs a structured, citable diff between the two editions to support the supplement’s justification narrative and to identify which qualified procedures need re-evaluation.

The engineer’s regulatory-authoring environment hosts a CLASP-aware AI assistant. The AI System issues list_changes between the two editions, then follows a normative reference in the 2026 edition via resolve_reference. The reference points to a clause in BPEC-200, Hygienic Design of Single-Use Bioprocess Components, which is published by a different SDO that the sponsor does not hold a license to. The response is a structured pointer, not text.

Step 1: CoMP handshake request

{
  "aisystem": {
    "name": "reg-authoring.example",
    "ua": "RegSubmissionAI/2.0",
    "id": "TL-REG-998877",
    "aisysuse": {
      "lid": "TMF-LIC-SPONSOR-2026-A7714",
      "aiauth": 2,
      "uri": ["https://retrieval.tmf.example/mcp"],
      "scope": 5,
      "function": [3],
      "subfn": [2],
      "resdis": 1,
      "ext": {
        "clasp_version": "0.1",
        "engineering_intent": [5],
        "target_designation": ["TMF-3050"],
        "target_edition": "2023",
        "target_edition_compare": "2026",
        "preferred_languages": ["en"],
        "deliverable_type": 4,
        "requester_authority": 1
      }
    }
  }
}

What this declares

  • function = [3] (ai-input), subfn = [2] (grounding): the AI System will use retrieved content to ground generated text in the regulatory submission.
  • engineering_intent = [5] (regulatory-submission): the engineering workflow is preparing a regulator-bound document.
  • target_edition = "2023", target_edition_compare = "2026": the session intends to use list_changes between these two editions. With target_edition_compare populated, target_edition is interpreted as the “from” edition.
  • deliverable_type = 4 (submitted-to-regulator): the strictest deliverable type. The Content Owner is expected to require exact_text_mode = 1 and may impose other constraints (some publishers require requester_authority = 0 for submitted-to-regulator; this publisher accepts organization-licensee).
  • requester_authority = 1 (organization-licensee): the firm is the licensee. The citation envelope will carry this through and any FDA reviewer can verify the firm-level attribution.

Step 2: CoMP handshake response

{
  "package": {
    "id": "PKG-TMF-3050-CROSSED-S122",
    "title": "TMF-3050 Cross-Edition Access (2023 to 2026)",
    "seller": "tmf.example",
    "licenseurl": "https://tmf.example/licensing/clasp-terms",
    "reporturl": "https://tmf.example/reporting/clasp-usage",
    "citation": 1,
    "scope": {
      "scope": 5,
      "ause": 0,
      "pricetype": 4,
      "pricetier": 2,
      "licensedur": 365,
      "max": 0,
      "ctype": [0],
      "text": [
        {
          "title": "TMF-3050-2023, Standard Guide for Verification of Continuous Pharmaceutical Manufacturing Systems",
          "language": [22],
          "pubdate": "2023-09-01T00:00:00Z",
          "author": ["Technical Methods Federation"],
          "sourcetype": 0
        },
        {
          "title": "TMF-3050-2026, Standard Guide for Verification of Continuous Pharmaceutical Manufacturing Systems",
          "language": [22],
          "pubdate": "2026-02-12T00:00:00Z",
          "author": ["Technical Methods Federation"],
          "sourcetype": 0
        }
      ],
      "ext": {
        "clasp_version": "0.1",
        "publisher": "tmf.example",
        "designation": "TMF-3050",
        "edition": "2026",
        "pubdate": "2026-02-12",
        "canonical_language": "en",
        "available_languages": ["en", "fr"],
        "supersedes": ["TMF-3050-2023"],
        "industry_sectors": [0, 1],
        "clause_scheme": "https://tmf.example/schemas/clause-scheme/3050-2026.json",
        "defined_terms_uri": "https://tmf.example/standards/3050/2026/defined-terms",
        "normative_refs": [
          {
            "designation": "BPEC-200",
            "edition": "2024",
            "publisher": "bpec.example",
            "clauses": ["8.3.2"]
          },
          {
            "designation": "TMF-3001",
            "edition": "2022",
            "publisher": "tmf.example",
            "clauses": ["4.1", "4.2"]
          }
        ],
        "regulatory_incorporations": [
          {
            "regulator": "example-pharma-regulator.gov",
            "regulation_id": "EX-CFR-211.X (proposed amendment, 2024)",
            "incorporation_date": "2024-11-01",
            "pinned_edition": "2023",
            "transition_window_start": "2026-07-01",
            "transition_window_end": "2027-12-31",
            "next_pinned_edition": "2026"
          }
        ]
      }
    },
    "retrieval": {
      "auth": 2,
      "endpoint": "https://retrieval.tmf.example/mcp",
      "type": [3],
      "ext": {
        "clasp_version": "0.1",
        "tools": [0, 1, 2, 3, 4],
        "exact_text_mode": 1,
        "citation_envelope": "https://clasp.example/schemas/citation-envelope-0.1.json"
      }
    }
  }
}

What this declares

  • scope.ext.edition is the “current” edition (2026). The supersedes chain records that 2023 is the prior edition. The target_edition from the handshake (2023) is licensed for this session even though it is superseded; cross-edition tools require both editions to be accessible.
  • regulatory_incorporations is populated: the regulator pinned the 2023 edition. The transition-window fields (transition_window_start: 2026-07-01, transition_window_end: 2027-12-31, next_pinned_edition: 2026) tell the AI System and the engineer that the regulator has announced a transition. The 2026 edition becomes acceptable for new submissions on 2026-07-01, and the 2023 edition is no longer acceptable after 2027-12-31. This is the architectural reason the engineer is generating a diff in the first place; the submission must justify why work qualified against the pinned edition is acceptable under the current edition, and the transition-window dates give the regulator’s reviewer a concrete frame for the justification.
  • normative_refs lists two normative references. One is to a TMF document (same publisher; the responding Content Owner can resolve it inline). The other is to BPEC-200, a different publisher; resolution will require a pointer.
  • retrieval.ext.tools = [0, 1, 2, 3, 4] includes list_changes (3) and resolve_reference (4), which is what this session needs.

Step 3: MCP tool call — list_changes

The AI System requests the change set between the two editions, filtered to the specific clause subtree that is operative for the supplement (the verification of continuous direct compression sub-process is covered in clauses 7.x).

Tool call:

{
  "tool": "list_changes",
  "arguments": {
    "clause_filter": "7..7.99"
  }
}

Response (abbreviated to three changes for readability; a real response would include all changes in the filter):

{
  "changes": [
    {
      "clause": "7.2.1",
      "change_kind": "modified",
      "before_text": "The verification plan SHALL include sampling at the outlet of the continuous direct compression line at a frequency sufficient to detect material composition drift over a single production campaign.",
      "after_text": "The verification plan SHALL include sampling at the outlet of the continuous direct compression line at a frequency sufficient to detect material composition drift over a single production campaign. Sampling frequency SHALL be defined as a function of the line's mean residence time, with a minimum of three samples per residence time interval, in accordance with the residence-time-distribution analysis required by 7.2.2.",
      "description": "Sampling frequency now has a normative minimum tied to mean residence time. Prior text was silent on minimum frequency. Impact: validation procedures qualifying sampling at fixed wall-clock intervals (e.g. every 15 minutes) must be reassessed against the new mean-residence-time-coupled criterion."
    },
    {
      "clause": "7.2.2",
      "change_kind": "added",
      "before_text": null,
      "after_text": "A residence-time-distribution analysis SHALL be performed for the continuous direct compression line as part of the verification plan. The analysis SHALL use the method described in TMF-3001:2022 clauses 4.1 and 4.2, or an equivalent method documented in the verification plan and accepted by the responsible quality function.",
      "description": "New normative clause introducing residence-time-distribution analysis as a verification-plan requirement. Cross-references TMF-3001:2022."
    },
    {
      "clause": "7.4.3",
      "change_kind": "modified",
      "before_text": "Wetted components in contact with active pharmaceutical ingredient streams SHALL comply with the hygienic design requirements of generally recognized industry practice.",
      "after_text": "Wetted components in contact with active pharmaceutical ingredient streams SHALL comply with BPEC-200:2024 clause 8.3.2.",
      "description": "Replaces 'generally recognized industry practice' with a normative reference to BPEC-200:2024 clause 8.3.2. Impact: components qualified under the prior text need a documented BPEC-200:2024 compliance assessment."
    }
  ],
  "envelope": {
    "envelope_version": "0.1",
    "tool": "list_changes",
    "publisher": "tmf.example",
    "designation": "TMF-3050",
    "primary_edition": "2023",
    "comparison_edition": "2026",
    "language": "en",
    "retrieval_timestamp": "2026-05-15T15:08:11Z",
    "endpoint_uri": "https://retrieval.tmf.example/mcp",
    "license_id_fingerprint": "sha256:6f5e4d3c2b1a0f9e8d7c6b5a4938271605f4e3d2c1b0a9988776655443322110",
    "deliverable_type": 4,
    "requester_authority": 1,
    "citations": [
      {
        "clause": "7.2.1",
        "mode": 3,
        "content_hash": "sha256:8a9b0c1d2e3f4a5b6c7d8e9f0a1b2c3d4e5f6a7b8c9d0e1f2a3b4c5d6e7f8a9b",
        "content_length": 692,
        "snippet": null,
        "diff": { "from_edition": "2023", "to_edition": "2026", "change_kind": "modified" },
        "pointer": null
      },
      {
        "clause": "7.2.2",
        "mode": 3,
        "content_hash": "sha256:9b0c1d2e3f4a5b6c7d8e9f0a1b2c3d4e5f6a7b8c9d0e1f2a3b4c5d6e7f8a9b0c",
        "content_length": 401,
        "snippet": null,
        "diff": { "from_edition": "2023", "to_edition": "2026", "change_kind": "added" },
        "pointer": null
      },
      {
        "clause": "7.4.3",
        "mode": 3,
        "content_hash": "sha256:0c1d2e3f4a5b6c7d8e9f0a1b2c3d4e5f6a7b8c9d0e1f2a3b4c5d6e7f8a9b0c1d",
        "content_length": 328,
        "snippet": null,
        "diff": { "from_edition": "2023", "to_edition": "2026", "change_kind": "modified" },
        "pointer": null
      }
    ]
  }
}

What this demonstrates

  • The envelope’s primary_edition is 2023 (the “from” edition) and comparison_edition is 2026. This is the one tool that populates both fields.
  • All three citations have mode = 3 (diff). Each diff sub-object records the editions compared and the kind of change. An AI System emitting a claim that “clause 7.2.2 is new in the 2026 edition” can be checked against a change_kind = added diff citation; no other mode supports such a claim.
  • The content_hash for each citation is computed over the canonical JSON serialization of the diff record, not over the clause text. The change_kind and the before/after text are part of the hashed structure, so a downstream reader can recompute the hash to verify integrity.

Step 4: MCP tool call — resolve_reference (same-publisher)

The 2026 edition’s clause 7.2.2 normatively cites TMF-3001:2022 clauses 4.1 and 4.2. The AI System resolves this reference. Because both designations belong to the same publisher (TMF), the response returns the clauses inline.

Tool call:

{
  "tool": "resolve_reference",
  "arguments": {
    "reference": {
      "designation": "TMF-3001",
      "edition": "2022",
      "clauses": ["4.1", "4.2"]
    },
    "mode": "exact-text"
  }
}

Response (showing just clause 4.1; clause 4.2 would follow the same pattern):

{
  "resolved": {
    "designation": "TMF-3001",
    "edition": "2022",
    "publisher": "tmf.example",
    "clauses": [
      {
        "clause": "4.1",
        "content": "The residence-time-distribution (RTD) analysis of a continuous process line SHALL be performed by introducing a tracer at the line inlet and measuring tracer concentration at the line outlet over time. The tracer SHALL be inert with respect to the process chemistry and detectable at the required sensitivity at the outlet measurement point. The method of tracer introduction SHALL be either pulse, step, or random binary sequence; the choice SHALL be documented in the analysis plan.",
        "mode": "exact-text"
      }
    ]
  },
  "envelope": {
    "envelope_version": "0.1",
    "tool": "resolve_reference",
    "publisher": "tmf.example",
    "designation": "TMF-3001",
    "primary_edition": "2022",
    "comparison_edition": null,
    "language": "en",
    "retrieval_timestamp": "2026-05-15T15:09:42Z",
    "endpoint_uri": "https://retrieval.tmf.example/mcp",
    "license_id_fingerprint": "sha256:6f5e4d3c2b1a0f9e8d7c6b5a4938271605f4e3d2c1b0a9988776655443322110",
    "deliverable_type": 4,
    "requester_authority": 1,
    "citations": [
      {
        "clause": "4.1",
        "mode": 0,
        "content_hash": "sha256:1d2e3f4a5b6c7d8e9f0a1b2c3d4e5f6a7b8c9d0e1f2a3b4c5d6e7f8a9b0c1d2e",
        "content_length": 487,
        "snippet": null,
        "diff": null,
        "pointer": null
      }
    ]
  }
}

What this demonstrates

  • The envelope’s designation is TMF-3001, not TMF-3050. A single CLASP session can return citation envelopes anchored to different standards as long as all such standards are within the session’s licensed scope.
  • mode = 0 (exact-text): the cited text is verbatim. The AI System may quote it in the regulatory submission as long as the envelope is attached.

Step 5: MCP tool call — resolve_reference (cross-publisher)

The 2026 edition’s clause 7.4.3 normatively cites BPEC-200:2024 clause 8.3.2. BPEC is a different publisher. The sponsor does not hold a BPEC license.

Tool call:

{
  "tool": "resolve_reference",
  "arguments": {
    "reference": {
      "designation": "BPEC-200",
      "edition": "2024",
      "clauses": ["8.3.2"]
    },
    "mode": "exact-text"
  }
}

Response:

{
  "resolved": {
    "designation": "BPEC-200",
    "edition": "2024",
    "publisher": "bpec.example",
    "clauses": [
      {
        "clause": "8.3.2",
        "pointer": {
          "target_publisher": "bpec.example",
          "target_designation": "BPEC-200",
          "target_edition": "2024",
          "target_clause": "8.3.2",
          "discoverability_uri": "https://bpec.example/.well-known/clasp-catalog"
        }
      }
    ]
  },
  "envelope": {
    "envelope_version": "0.1",
    "tool": "resolve_reference",
    "publisher": "tmf.example",
    "designation": "BPEC-200",
    "primary_edition": "2024",
    "comparison_edition": null,
    "language": null,
    "retrieval_timestamp": "2026-05-15T15:10:18Z",
    "endpoint_uri": "https://retrieval.tmf.example/mcp",
    "license_id_fingerprint": "sha256:6f5e4d3c2b1a0f9e8d7c6b5a4938271605f4e3d2c1b0a9988776655443322110",
    "deliverable_type": 4,
    "requester_authority": 1,
    "citations": [
      {
        "clause": "8.3.2",
        "mode": 5,
        "content_hash": "sha256:2e3f4a5b6c7d8e9f0a1b2c3d4e5f6a7b8c9d0e1f2a3b4c5d6e7f8a9b0c1d2e3f",
        "content_length": 218,
        "snippet": null,
        "diff": null,
        "pointer": {
          "target_publisher": "bpec.example",
          "target_designation": "BPEC-200",
          "target_edition": "2024",
          "target_clause": "8.3.2",
          "discoverability_uri": "https://bpec.example/.well-known/clasp-catalog"
        }
      }
    ]
  }
}

What this demonstrates

  • The envelope’s publisher (tmf.example) and the citation’s pointer.target_publisher (bpec.example) are different. This is the cross-publisher case.
  • mode = 5 (pointer): the AI System has NOT received the text of BPEC-200:2024 clause 8.3.2. It has received a structured pointer to where that text can be licensed. Downstream emission rules apply: the AI System MUST NOT quote BPEC-200 clause 8.3.2 based on this envelope. It can disclose to the engineer that the reference exists and direct them to the BPEC discoverability catalog.
  • content_hash is over the canonical JSON serialization of the pointer object, not over clause text. There is no clause text to hash.
  • endpoint_uri is the TMF endpoint, because the TMF endpoint generated the pointer; the AI System would need a separate handshake with BPEC to retrieve the actual clause text.
  • The envelope’s language field is null. Pointer-only responses do not include any rendered text, so no language attaches; this is the only envelope shape that legitimately has a null language.

What this example demonstrates that the others do not

  • target_edition_compare populated; the envelope’s primary_edition and comparison_edition both populated for list_changes.
  • mode = 3 (diff) and mode = 5 (pointer) citation types.
  • submitted-to-regulator deliverable type forcing exact_text_mode = 1 and the strictest envelope discipline.
  • organization-licensee requester_authority.
  • A single session spanning citations from two designations (TMF-3050, TMF-3001) and a pointer to a third (BPEC-200).
  • regulatory_incorporations populated with transition-window fields (transition_window_start, transition_window_end, next_pinned_edition), capturing why the engineer is doing the diff and giving the regulator’s reviewer a concrete frame for the transition justification.
  • available_languages declaring more than one rendering (["en", "fr"]); the AI System’s preferred_languages: ["en"] selects English, but a French-language retrieval would have been available within the same session.
  • A language: null envelope (Step 5), demonstrating the cross-publisher pointer case where no language attaches.

Notes on the protocol surface

  • The clause_filter argument to list_changes is an MCP tool argument and is not part of the CoMP handshake. It is also not part of target_clauses in the handshake; target_clauses declares the session’s authorized clause subset (here, none specified, meaning the full standard is in scope), while clause_filter narrows the specific tool call.
  • The target_clauses renumbering case is handled by CLASP-0.1: default is the “to” edition’s numbering, with explicit override via target_clauses_numbering. This example continues to leave target_clauses unset at session level (filtering at tool-call time) because the scenario doesn’t need to narrow the diff; the mechanism is available for scenarios that do.
  • The Object: RegulatoryIncorporation shape used here is the CLASP-0.1 form, including the transition-window fields. The multi-jurisdiction case is addressed in CLASP-0.1 prose: the Content Owner surfaces all incorporations; the AI System filters by session context. This example shows only one regulator; a multi-regulator example would just populate the array with multiple entries and let the AI System pick by deliverable target.
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