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 Section

Retrieve a specific section from an ICH guideline including full text, subsections, and CFR cross-references.

Endpoint

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

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\}`)
`section`	string	Yes	Section number (e.g., `4.4`, `2.1`, `12.4`) (path parameter: `\{section\}`)

Query Parameters

Parameter	Type	Required	Description
`include_subsections`	boolean	No	Include all subsections (default: `true`)
`include_cfr_mappings`	boolean	No	Include CFR cross-references (default: `true`)
`include_context`	boolean	No	Include parent section context (default: `false`)

Example Request

curl -X GET "https://api.ctwise.ai/v1/kg/ich/Q7/4.4?include_subsections=true&include_cfr_mappings=true" \
  -H "Content-Type: application/json"

Response

Success (200)

{
  "guideline_info": {
    "guideline_id": "Q7",
    "full_title": "ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients",
    "version": "November 2000",
    "effective_date": "2001-11-01"
  },
  "section": {
    "section_number": "4.4",
    "section_id": "Q7-4.4",
    "title": "Sanitation",
    "parent_section": {
      "section_number": "4",
      "title": "Buildings and Facilities"
    },
    "full_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 that would alter the quality of the API beyond the official or other established specifications.",
    "subsections": [
      {
        "subsection": "4.41",
        "text": "Written procedures should be established assigning responsibility for sanitation and describing the cleaning schedules, methods, equipment, and materials to be used in cleaning buildings and facilities."
      },
      {
        "subsection": "4.42",
        "text": "Such procedures should also address the removal or obliteration of previous batch identification."
      },
      {
        "subsection": "4.43",
        "text": "Written procedures should be established for the use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents. Such written procedures should be designed to prevent the contamination of equipment, raw materials, packaging/labeling materials, intermediates, or APIs."
      }
    ],
    "key_requirements": [
      "Adequate maintenance of buildings and facilities",
      "Cleaning and sanitization programs",
      "Prevention of contamination and cross-contamination",
      "Written sanitation procedures",
      "Removal of previous batch identification",
      "Pest control procedures"
    ],
    "applicability": {
      "manufacturing_stages": ["all API manufacturing stages"],
      "facility_types": ["API manufacturing facilities", "packaging facilities"],
      "product_types": ["chemical synthesis", "extraction", "fermentation", "cell culture"]
    }
  },
  "cfr_cross_references": [
    {
      "cfr_section": "21 CFR 211.56",
      "title": "Sanitation",
      "relevance": "direct",
      "mapping_type": "equivalent",
      "mapping_rationale": "ICH Q7 Section 4.4 directly aligns with 21 CFR 211.56 sanitation requirements for pharmaceutical manufacturing facilities. Both require written procedures, adequate maintenance, and pest control measures.",
      "cfr_text_excerpt": "Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition. Written procedures shall be established and followed for cleaning and maintenance.",
      "alignment_score": 0.95,
      "subsection_mappings": [
        {
          "ich_subsection": "4.41",
          "cfr_subsection": "21 CFR 211.56(c)",
          "alignment": "direct",
          "notes": "Both require written cleaning procedures with schedules and methods"
        },
        {
          "ich_subsection": "4.43",
          "cfr_subsection": "21 CFR 211.56(d)",
          "alignment": "direct",
          "notes": "Both require written procedures for pest control agents to prevent contamination"
        }
      ]
    },
    {
      "cfr_section": "21 CFR 211.67",
      "title": "Equipment cleaning and maintenance",
      "relevance": "supporting",
      "mapping_type": "related",
      "mapping_rationale": "Related requirements for equipment cleaning procedures that complement facility sanitation requirements in ICH Q7 4.4.",
      "cfr_text_excerpt": "Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination.",
      "alignment_score": 0.78,
      "subsection_mappings": [
        {
          "ich_subsection": "4.41",
          "cfr_subsection": "21 CFR 211.67(a)",
          "alignment": "supporting",
          "notes": "Cleaning schedules and methods apply to both facilities and equipment"
        }
      ]
    },
    {
      "cfr_section": "21 CFR 211.42",
      "title": "Design and construction features",
      "relevance": "indirect",
      "mapping_type": "prerequisite",
      "mapping_rationale": "Facility design must support sanitation requirements; prerequisite to effective cleaning and maintenance.",
      "cfr_text_excerpt": "Any building used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations.",
      "alignment_score": 0.65
    }
  ],
  "related_ich_sections": [
    {
      "section": "Q7-5.3",
      "title": "Maintenance and Cleaning",
      "relationship": "complementary",
      "description": "Equipment-specific cleaning requirements that support facility sanitation"
    },
    {
      "section": "Q7-12.4",
      "title": "Cleaning Validation",
      "relationship": "implementation",
      "description": "Validation requirements for cleaning procedures described in 4.4"
    },
    {
      "section": "Q9-2.3",
      "title": "Risk Assessment",
      "relationship": "methodology",
      "description": "Risk-based approach to determining sanitation frequency and methods"
    }
  ],
  "practical_guidance": {
    "implementation_steps": [
      "Develop written sanitation procedures for all manufacturing areas",
      "Establish cleaning schedules based on risk assessment (frequency, methods)",
      "Define responsibilities for sanitation activities",
      "Implement pest control program with approved agents",
      "Validate cleaning procedures per ICH Q7 Section 12.4",
      "Train personnel on sanitation procedures and requirements",
      "Monitor and document sanitation activities"
    ],
    "common_deficiencies": [
      "Lack of written sanitation procedures",
      "Inadequate cleaning frequency for high-risk areas",
      "Evidence of pest infestation (spiders, rodents, insects)",
      "Failure to remove previous batch identification",
      "Use of unapproved pest control agents",
      "Inadequate documentation of sanitation activities"
    ],
    "inspection_focus_areas": [
      "Availability and adequacy of written sanitation SOPs",
      "Physical condition of facilities (cleanliness, pest evidence)",
      "Sanitation records and cleaning logs",
      "Pest control program documentation",
      "Cleaning validation reports",
      "Personnel training records on sanitation procedures"
    ]
  },
  "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",
      "page_reference": "Section 4.4, Pages 12-13"
    },
    {
      "source_type": "cfr_regulations",
      "source_id": "cfr-title21-2024-04-01",
      "retrieval_method": "cross_reference_mapping",
      "confidence": 1.0,
      "publication_date": "2024-04-01"
    },
    {
      "source_type": "fda_483_database",
      "source_id": "fda-483-analytics-2020-2024",
      "retrieval_method": "deficiency_pattern_analysis",
      "confidence": 0.96,
      "data_period": "2020-2024"
    }
  ],
  "evidence_chain": {
    "chain_integrity": "verified",
    "evidence_coverage": 1.0,
    "provenance_complete": true,
    "sources_verified": 3,
    "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": "vwx123-yza456"
  }
}

Response Fields

Field	Type	Description
`guideline_info`	object	Parent guideline metadata
`guideline_info.guideline_id`	string	ICH guideline identifier
`guideline_info.full_title`	string	Complete guideline title
`section`	object	Requested section details
`section.section_number`	string	Section number (e.g., "4.4")
`section.section_id`	string	Unique section identifier (e.g., "Q7-4.4")
`section.title`	string	Section title
`section.parent_section`	object	Parent section context (if applicable)
`section.full_text`	string	Complete section text
`section.subsections`	array	All subsections with text
`section.key_requirements`	string[]	Key regulatory requirements from this section
`section.applicability`	object	Applicability context (stages, facility types, products)
`cfr_cross_references`	array	Related CFR sections with detailed mappings
`cfr_cross_references[].cfr_section`	string	CFR citation
`cfr_cross_references[].title`	string	CFR section title
`cfr_cross_references[].relevance`	string	`direct`, `supporting`, or `indirect`
`cfr_cross_references[].mapping_type`	string	Mapping type: `equivalent`, `related`, `prerequisite`
`cfr_cross_references[].mapping_rationale`	string	Explanation of relationship
`cfr_cross_references[].alignment_score`	number	Alignment strength (0-1)
`cfr_cross_references[].subsection_mappings`	array	Detailed subsection-level mappings
`related_ich_sections`	array	Related sections from this or other ICH guidelines
`practical_guidance`	object	Implementation guidance and common deficiencies
`practical_guidance.implementation_steps`	string[]	Step-by-step implementation guidance
`practical_guidance.common_deficiencies`	string[]	Common FDA 483 deficiencies for this area
`practical_guidance.inspection_focus_areas`	string[]	Typical inspection focus areas
`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
400	Invalid section format	`{"error": "Invalid section format. Use format: X.Y (e.g., 4.4)"}`	Use correct section number format
404	Section not found	`{"error": "Section 99.99 not found in guideline Q7"}`	Verify section exists in guideline
500	Retrieval failure	`{"error": "Internal retrieval error"}`	Retry request; check Lambda logs

Section Number Formats

Format	Valid	Example	Notes
`4.4`	Yes	Major section with subsection	Recommended format
`2`	Yes	Top-level section	Returns all subsections
`12.40`	Yes	Subsection with trailing zero	Auto-normalized to 12.4
`4-4`	No	Use period separator	Use `4.4` instead
`Section 4.4`	No	No prefix text	Use `4.4` only

Common ICH Q7 Sections

Section	Title	CFR Alignments
2.1	Principles (Quality Management)	21 CFR 211.22
2.2	Responsibilities of the Quality Unit(s)	21 CFR 211.22
4.4	Sanitation	21 CFR 211.56, 211.67
5.3	Maintenance and Cleaning	21 CFR 211.67
10.2	Storage Procedures	21 CFR 211.142
11.1	General Controls	21 CFR 211.100, 211.110
12.1	Validation Policy	21 CFR 211.100
12.4	Cleaning Validation	21 CFR 211.67

Common ICH Q9 Sections

Section	Title	CFR Applications
2.1	Risk Management Process	Risk-based approach to all CFR requirements
2.2	Risk Assessment	Applied to validation, change control, deviations
2.3	Risk Control	CAPA, preventive measures per 21 CFR 211.100
3	Risk Management Methodology	Tools for CFR compliance decisions

Common ICH Q10 Sections

Section	Title	CFR Alignments
1.3	Relationship with ISO Standards	Quality system framework
2.1	Management Responsibility	21 CFR 211.22 (quality unit)
2.3	Outsourced Activities	21 CFR 211.22 (quality oversight)
2.5	Knowledge Management	Product lifecycle approach to CFR compliance

Usage Examples

Get Specific Q7 Section

curl -X GET "https://api.ctwise.ai/v1/kg/ich/Q7/12.4" \
  -H "Content-Type: application/json"

Get Q9 Section with Context

curl -X GET "https://api.ctwise.ai/v1/kg/ich/Q9/2.2?include_context=true&include_cfr_mappings=true" \
  -H "Content-Type: application/json"

Get Q10 Top-Level Section

curl -X GET "https://api.ctwise.ai/v1/kg/ich/Q10/2?include_subsections=true" \
  -H "Content-Type: application/json"

Minimal Response (No Extras)

curl -X GET "https://api.ctwise.ai/v1/kg/ich/Q7/5.3?include_subsections=false&include_cfr_mappings=false" \
  -H "Content-Type: application/json"

CFR Mapping Alignment Scores

Alignment Score	Interpretation	Mapping Type
0.90 - 1.0	Near-identical requirements	Equivalent
0.75 - 0.89	Closely related requirements	Related
0.60 - 0.74	Supporting or complementary	Supporting
0.40 - 0.59	Indirect relationship	Prerequisite/Context
< 0.40	Weak or tangential relationship	Not mapped

Performance Characteristics

Metric	Typical Value	Notes
Response Time	100-300ms	Faster than full guideline retrieval
Cache Duration	7 days	Section content rarely changes
Data Freshness	Updated annually	ICH guidelines stable
Response Size	5-20 KB	Depends on section size and includes

Notes

Authorization: Requires Starter+ subscription tier
Content Source: Official ICH guideline documents
CFR Mappings: Curated by regulatory affairs SMEs; includes alignment scores
Practical Guidance: Based on 15,000+ FDA 483 observations (2020-2024)
Evidence Framework: All responses include full provenance (P0 non-negotiable)
Subsection Depth: Returns all subsections within requested section
Rate Limiting: Starter: 1,000 requests/day; Pro: 10,000 requests/day; Enterprise: unlimited
Language: English only (multilingual support planned)

Use Cases

Procedure Development

Reference specific ICH requirements during SOP writing
Identify all CFR sections that must be addressed for compliance
Use practical guidance for implementation steps
Review common deficiencies to build robust procedures

Gap Analysis

Compare current procedures against specific ICH section requirements
Identify CFR alignment gaps using detailed subsection mappings
Use key_requirements field for compliance checklist development
Benchmark against common_deficiencies from industry data

Training and Education

Provide focused ICH section content for targeted training
Demonstrate ICH-CFR alignment for compliance training
Use implementation_steps for hands-on training exercises
Reference inspection_focus_areas for audit readiness training

Inspection Preparation

Review specific sections likely to be inspected
Prepare talking points using CFR cross-references
Anticipate inspector questions using inspection_focus_areas
Ensure documentation addresses all key_requirements

Regulatory Intelligence

Track regulatory expectations for specific compliance areas
Understand harmonized vs. divergent requirements (ICH vs CFR)
Use alignment_scores to prioritize compliance efforts
Monitor related_ich_sections for broader context

Get ICH Guideline - Retrieve complete ICH guideline
Get CFR Regulation - View mapped CFR sections in detail
Classify Event - Classify events and find relevant ICH sections
Investigate Event - Investigation includes relevant ICH sections

Endpoint​

Request​

Path Parameters​

Query Parameters​

Example Request​

Response​

Success (200)​

Response Fields​

Error Responses​

Section Number Formats​

Common ICH Q7 Sections​

Common ICH Q9 Sections​

Common ICH Q10 Sections​

Usage Examples​

Get Specific Q7 Section​

Get Q9 Section with Context​

Get Q10 Top-Level Section​

Minimal Response (No Extras)​

CFR Mapping Alignment Scores​

Performance Characteristics​

Notes​

Use Cases​

Procedure Development​

Gap Analysis​

Training and Education​

Inspection Preparation​

Regulatory Intelligence​

Related Endpoints​