What regulatory sources does CTWiseAPI cover?

CTWiseAPI provides access to FDA Guidance Documents, ICH Guidelines (International Council for Harmonisation), EMA Regulations (European Medicines Agency), and WHO Standards (World Health Organization) for clinical trial compliance.

How does CTWiseAPI semantic search work?

CTWiseAPI uses AI-powered semantic search with AWS Bedrock Titan embeddings to understand the meaning of your regulatory queries, not just keywords. This enables natural language questions like 'informed consent requirements for Phase 1 trials' to return highly relevant results.

What are evidence chains in CTWiseAPI?

Evidence chains provide complete traceability from search results back to authoritative source documents, including source authority, document ID, section references, and confidence scores - essential for compliance audits and regulatory submissions.

Get ICH Guideline

Retrieve complete ICH (International Council for Harmonisation) guideline content with all sections, CFR cross-references, and regulatory mappings.

Endpoint

GET /v1/kg/ich/\{guideline\}

Base URL: https://api.ctwise.ai

Authorization Tier: Starter+

Request

Path Parameters

Parameter	Type	Required	Description
`guideline`	string	Yes	ICH guideline identifier: `Q7`, `Q9`, or `Q10` (path parameter: `\{guideline\}`)

Query Parameters

Parameter	Type	Required	Description
`include_sections`	boolean	No	Include all section details (default: `true`)
`include_cfr_mappings`	boolean	No	Include CFR cross-references for each section (default: `true`)
`section_depth`	string	No	Section detail level: `summary`, `full` (default: `full`)

Example Request

curl -X GET "https://api.ctwise.ai/v1/kg/ich/Q7?include_sections=true&include_cfr_mappings=true" \
  -H "Content-Type: application/json"

Response

Success (200)

{
  "guideline": {
    "guideline_id": "Q7",
    "full_title": "ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients",
    "version": "November 2000",
    "effective_date": "2001-11-01",
    "scope": "This document provides guidance on Good Manufacturing Practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.",
    "applicability": "Applies to the manufacture of APIs for use in the manufacture of drug products, including APIs manufactured by chemical synthesis, extraction, cell culture/fermentation, recovery from natural sources, or any combination.",
    "regulatory_status": "FDA adopted as guidance",
    "last_updated": "2024-01-15"
  },
  "table_of_contents": [
    {
      "section": "1",
      "title": "Introduction",
      "subsections": ["1.1", "1.2", "1.3", "1.4", "1.5"]
    },
    {
      "section": "2",
      "title": "Quality Management",
      "subsections": ["2.1", "2.2", "2.3", "2.4", "2.5"]
    },
    {
      "section": "3",
      "title": "Personnel",
      "subsections": ["3.1", "3.2", "3.3"]
    },
    {
      "section": "4",
      "title": "Buildings and Facilities",
      "subsections": ["4.1", "4.2", "4.3", "4.4", "4.5"]
    },
    {
      "section": "5",
      "title": "Process Equipment",
      "subsections": ["5.1", "5.2", "5.3", "5.4", "5.5"]
    },
    {
      "section": "10",
      "title": "Storage and Distribution",
      "subsections": ["10.1", "10.2", "10.3"]
    },
    {
      "section": "12",
      "title": "Validation",
      "subsections": ["12.1", "12.2", "12.3", "12.4", "12.5"]
    }
  ],
  "sections": [
    {
      "section": "1",
      "title": "Introduction",
      "text": "This document provides guidance on Good Manufacturing Practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is intended to be used in conjunction with national and regional GMPs.",
      "subsections": [
        {
          "section": "1.1",
          "title": "Objective",
          "text": "This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.",
          "cfr_mappings": []
        },
        {
          "section": "1.2",
          "title": "Regulatory Applicability",
          "text": "This document is intended to cover the manufacture of APIs for use in the manufacture of drug products (dosage forms). It applies to the manufacture of sterile APIs only up to the point immediately prior to the API being rendered sterile.",
          "cfr_mappings": [
            {
              "cfr_section": "21 CFR 211.1",
              "title": "Scope",
              "relevance": "direct",
              "mapping_rationale": "Establishes scope of GMP requirements similar to ICH Q7 applicability"
            }
          ]
        }
      ]
    },
    {
      "section": "2",
      "title": "Quality Management",
      "text": "The company should have a comprehensive quality management system that includes Good Manufacturing Practice and Quality Risk Management.",
      "subsections": [
        {
          "section": "2.1",
          "title": "Principles",
          "text": "Quality should be the responsibility of all persons involved in manufacturing. Companies should establish a comprehensive quality management system that includes Good Manufacturing Practice and Quality Risk Management.",
          "cfr_mappings": [
            {
              "cfr_section": "21 CFR 211.22",
              "title": "Responsibilities of quality control unit",
              "relevance": "direct",
              "mapping_rationale": "Both establish quality unit responsibilities and authority"
            }
          ]
        },
        {
          "section": "2.2",
          "title": "Responsibilities of the Quality Unit(s)",
          "text": "The quality unit(s) should be independent of production and should fulfill both quality assurance (QA) and quality control (QC) responsibilities.",
          "cfr_mappings": [
            {
              "cfr_section": "21 CFR 211.22",
              "title": "Responsibilities of quality control unit",
              "relevance": "direct",
              "mapping_rationale": "Direct parallel to CFR requirements for QC unit independence"
            }
          ]
        }
      ]
    },
    {
      "section": "4",
      "title": "Buildings and Facilities",
      "text": "Buildings and facilities used in the manufacture of APIs should be located, designed, and constructed to facilitate cleaning, maintenance, and operations as appropriate to the type and stage of manufacture.",
      "subsections": [
        {
          "section": "4.4",
          "title": "Sanitation",
          "text": "Buildings and facilities used in the manufacture of APIs should be adequately maintained, cleaned and, when applicable to the nature of the API, sanitized and/or disinfected to prevent contamination or carry-over of a material.",
          "cfr_mappings": [
            {
              "cfr_section": "21 CFR 211.56",
              "title": "Sanitation",
              "relevance": "direct",
              "mapping_rationale": "Direct alignment on sanitation requirements for manufacturing facilities"
            },
            {
              "cfr_section": "21 CFR 211.67",
              "title": "Equipment cleaning and maintenance",
              "relevance": "supporting",
              "mapping_rationale": "Related requirements for cleaning and maintenance procedures"
            }
          ]
        }
      ]
    },
    {
      "section": "10",
      "title": "Storage and Distribution",
      "text": "Procedures should be established for the storage and distribution of APIs to ensure their quality is maintained throughout the storage and distribution chain.",
      "subsections": [
        {
          "section": "10.2",
          "title": "Storage Procedures",
          "text": "Materials should be stored under appropriate conditions (e.g., temperature, humidity, light). Special provisions should be observed for certain materials such as photosensitive, hygroscopic, or flammable materials.",
          "cfr_mappings": [
            {
              "cfr_section": "21 CFR 211.142",
              "title": "Warehousing procedures",
              "relevance": "direct",
              "mapping_rationale": "Parallel requirements for storage conditions and procedures"
            }
          ]
        }
      ]
    },
    {
      "section": "12",
      "title": "Validation",
      "text": "Studies to demonstrate that manufacturing processes, analytical methods, cleaning procedures, and computerized systems are suitable for their intended use and consistently perform as intended.",
      "subsections": [
        {
          "section": "12.1",
          "title": "Validation Policy",
          "text": "The company's overall policy, intentions, and approach to validation should be documented.",
          "cfr_mappings": [
            {
              "cfr_section": "21 CFR 211.100",
              "title": "Written procedures; deviations",
              "relevance": "supporting",
              "mapping_rationale": "Validation procedures must be documented per written procedure requirements"
            }
          ]
        },
        {
          "section": "12.4",
          "title": "Cleaning Validation",
          "text": "Cleaning procedures should normally be validated. In general, cleaning validation should be directed to situations or process steps where contamination or carryover of materials poses the greatest risk to API quality.",
          "cfr_mappings": [
            {
              "cfr_section": "21 CFR 211.67",
              "title": "Equipment cleaning and maintenance",
              "relevance": "direct",
              "mapping_rationale": "Establishes requirement for validated cleaning procedures"
            }
          ]
        }
      ]
    }
  ],
  "cfr_cross_reference_summary": {
    "total_cfr_mappings": 47,
    "direct_mappings": 32,
    "supporting_mappings": 15,
    "most_referenced_cfr": [
      {
        "cfr_section": "21 CFR 211.22",
        "title": "Responsibilities of quality control unit",
        "mapping_count": 5,
        "ich_sections": ["2.1", "2.2", "6.1", "11.1"]
      },
      {
        "cfr_section": "21 CFR 211.100",
        "title": "Written procedures; deviations",
        "mapping_count": 4,
        "ich_sections": ["2.5", "6.3", "11.2", "12.1"]
      },
      {
        "cfr_section": "21 CFR 211.67",
        "title": "Equipment cleaning and maintenance",
        "mapping_count": 3,
        "ich_sections": ["4.4", "5.3", "12.4"]
      }
    ]
  },
  "related_guidelines": [
    {
      "guideline_id": "Q9",
      "title": "Quality Risk Management",
      "relationship": "complementary",
      "description": "Q9 provides risk management framework referenced in Q7 Section 2.1"
    },
    {
      "guideline_id": "Q10",
      "title": "Pharmaceutical Quality System",
      "relationship": "complementary",
      "description": "Q10 provides quality system framework that encompasses Q7 GMP requirements"
    }
  ],
  "evidence_sources": [
    {
      "source_type": "ich_guidelines",
      "source_id": "ich-q7-november-2000",
      "retrieval_method": "direct_lookup",
      "confidence": 1.0,
      "publication_date": "2000-11-01",
      "authority": "International Council for Harmonisation"
    },
    {
      "source_type": "cfr_regulations",
      "source_id": "cfr-title21-2024-04-01",
      "retrieval_method": "cross_reference_mapping",
      "confidence": 1.0,
      "publication_date": "2024-04-01"
    }
  ],
  "evidence_chain": {
    "chain_integrity": "verified",
    "evidence_coverage": 1.0,
    "provenance_complete": true,
    "sources_verified": 2,
    "last_verification_date": "2024-04-01"
  },
  "response_metadata": {
    "ich_database_version": "2024.01",
    "cfr_database_version": "2024.04.01",
    "processing_timestamp": "2026-03-03T12:00:00Z",
    "resolver_version": "1.0.0",
    "lambda_request_id": "pqr456-stu789"
  }
}

Response Fields

Field	Type	Description
`guideline`	object	Core guideline metadata
`guideline.guideline_id`	string	ICH guideline identifier (Q7, Q9, Q10)
`guideline.full_title`	string	Complete official title
`guideline.version`	string	Guideline version and date
`guideline.effective_date`	string	Date guideline became effective (ISO 8601)
`guideline.scope`	string	Official scope statement
`guideline.applicability`	string	Applicability description
`guideline.regulatory_status`	string	FDA adoption status
`table_of_contents`	array	Complete section structure
`table_of_contents[].section`	string	Section number
`table_of_contents[].title`	string	Section title
`table_of_contents[].subsections`	string[]	Subsection numbers
`sections`	array	All sections with full content
`sections[].section`	string	Section number
`sections[].title`	string	Section title
`sections[].text`	string	Section content
`sections[].subsections`	array	Subsections with content
`sections[].subsections[].section`	string	Subsection number
`sections[].subsections[].title`	string	Subsection title
`sections[].subsections[].text`	string	Subsection content
`sections[].subsections[].cfr_mappings`	array	CFR cross-references for this subsection
`cfr_cross_reference_summary`	object	Summary of all CFR mappings
`cfr_cross_reference_summary.total_cfr_mappings`	number	Total CFR cross-references
`cfr_cross_reference_summary.direct_mappings`	number	Direct (1:1) CFR mappings
`cfr_cross_reference_summary.supporting_mappings`	number	Supporting CFR mappings
`cfr_cross_reference_summary.most_referenced_cfr`	array	Most frequently referenced CFR sections
`related_guidelines`	array	Related ICH guidelines
`evidence_sources`	array	Data sources used
`evidence_chain`	object	Evidence integrity metrics
`response_metadata`	object	Processing metadata

Error Responses

Status	Cause	Response Example	Resolution
400	Invalid guideline ID	`{"error": "Invalid guideline. Must be: Q7, Q9, or Q10"}`	Use Q7, Q9, or Q10
404	Guideline not found	`{"error": "Guideline not found: Q11"}`	Verify guideline is supported
500	Retrieval failure	`{"error": "Internal retrieval error"}`	Retry request; check Lambda logs

Supported ICH Guidelines

Guideline	Title	Scope	Sections
Q7	Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients	API manufacturing GMP	19 main sections
Q9	Quality Risk Management	Risk-based approach to quality	7 main sections
Q10	Pharmaceutical Quality System	Quality management system framework	5 main sections

Usage Examples

Complete Q7 Guideline

curl -X GET "https://api.ctwise.ai/v1/kg/ich/Q7" \
  -H "Content-Type: application/json"

Q9 Summary (No CFR Mappings)

curl -X GET "https://api.ctwise.ai/v1/kg/ich/Q9?include_cfr_mappings=false&section_depth=summary" \
  -H "Content-Type: application/json"

Q10 Table of Contents Only

curl -X GET "https://api.ctwise.ai/v1/kg/ich/Q10?include_sections=false" \
  -H "Content-Type: application/json"

ICH Guideline Overview

ICH Q7: Good Manufacturing Practice for APIs

Purpose: Harmonized GMP guidance for API manufacturing
Key Topics: Quality management, facilities, equipment, materials, production, validation
CFR Alignment: Strong alignment with 21 CFR Parts 210 and 211
Industry Adoption: Widely adopted globally for API manufacturing

ICH Q9: Quality Risk Management

Purpose: Systematic approach to quality risk management
Key Topics: Risk assessment, risk control, risk communication, risk review
Risk Tools: FMEA, HACCP, PHA, etc.
CFR Alignment: Supports risk-based approach to 21 CFR compliance
Industry Adoption: Foundation for risk-based validation and change control

ICH Q10: Pharmaceutical Quality System

Purpose: Comprehensive quality management system model
Key Topics: Management responsibility, resources, product realization, monitoring
QMS Framework: Encompasses GMP, quality risk management, product lifecycle
CFR Alignment: Quality system framework for 21 CFR compliance
Industry Adoption: Basis for modern pharmaceutical quality systems

CFR Mapping Types

Direct Mappings

ICH section directly corresponds to specific CFR requirement
Identical or nearly identical regulatory intent
Example: ICH Q7 Section 2.2 (Quality Unit Responsibilities) → 21 CFR 211.22

Supporting Mappings

ICH section supports or complements CFR requirement
Related but not identical requirements
Example: ICH Q7 Section 12.1 (Validation Policy) → 21 CFR 211.100 (Written Procedures)

Performance Characteristics

Metric	Typical Value	Notes
Response Time	200-500ms	Depends on section_depth and includes parameters
Full Guideline Size	50-150 KB	Q7 is largest (150+ sections)
Cache Duration	7 days	Guidelines updated infrequently
Data Freshness	Updated annually	ICH guidelines stable; CFR mappings updated quarterly

Notes

Authorization: Requires Starter+ subscription tier
Content Source: Official ICH guideline documents (November 2000 for Q7, 2005 for Q9, 2008 for Q10)
CFR Mappings: Curated by regulatory affairs SMEs; reviewed quarterly
Evidence Framework: All responses include full provenance (P0 non-negotiable)
Language: English only (multilingual support planned)
Updates: Guideline content updated when ICH publishes revisions
Rate Limiting: Starter: 1,000 requests/day; Pro: 10,000 requests/day; Enterprise: unlimited
Export: Enterprise tier supports PDF export of full guidelines (contact support)

Use Cases

Regulatory Affairs

Reference ICH guidelines during submission preparation
Map company procedures to ICH requirements
Identify gaps between internal practices and ICH expectations
Support harmonization initiatives for global operations

Quality Assurance

Develop SOPs aligned with ICH Q7 GMP requirements
Implement risk-based approaches per ICH Q9
Design quality systems following ICH Q10 framework
Cross-reference ICH and CFR during procedure updates

Training and Education

Provide comprehensive ICH guideline access for training programs
Demonstrate alignment between ICH and CFR requirements
Support compliance training with official guideline text
Enable self-service learning for quality professionals

Audit and Inspection Preparation

Review ICH expectations for inspected areas
Prepare inspection readiness using ICH/CFR cross-references
Brief auditors on harmonized GMP approach
Demonstrate alignment with international standards

Get ICH Section - Retrieve specific ICH section with CFR cross-references
Get CFR Regulation - View CFR sections referenced in ICH guidelines
Classify Event - Classify events with ICH guideline context
Investigate Event - Investigation includes relevant ICH sections

Endpoint​

Request​

Path Parameters​

Query Parameters​

Example Request​

Response​

Success (200)​

Response Fields​

Error Responses​

Supported ICH Guidelines​

Usage Examples​

Complete Q7 Guideline​

Q9 Summary (No CFR Mappings)​

Q10 Table of Contents Only​

ICH Guideline Overview​

ICH Q7: Good Manufacturing Practice for APIs​

ICH Q9: Quality Risk Management​

ICH Q10: Pharmaceutical Quality System​

CFR Mapping Types​

Direct Mappings​

Supporting Mappings​

Performance Characteristics​

Notes​

Use Cases​

Regulatory Affairs​

Quality Assurance​

Training and Education​

Audit and Inspection Preparation​

Related Endpoints​