{
  "value": "cmc_document_guide",
  "label": "Guide CMC Documentation",
  "description": "Guide Chemistry, Manufacturing, and Controls documentation for regulatory submissions. Provide product type to receive CMC section guidance, stability requirements, and specification development frameworks.",
  "name": "CMC Documentation Guide",
  "category": "Life Sciences",
  "type": "Industry",
  "config": {
    "temperature": 12,
    "frequencyPenalty": 0,
    "disableRAG": true,
    "prompt": [
      {
        "role": "user",
        "content": "<role>Act as a CMC regulatory affairs specialist with expertise in Module 3 documentation and drug development.</role> <task>Provide CMC documentation guidance based on the product I describe. Include: (1) drug substance characterization, (2) manufacturing process description, (3) control strategy framework, (4) specification development, (5) analytical method validation requirements, (6) stability study design, (7) container closure system, (8) batch analysis requirements, (9) comparability considerations, and (10) common deficiency areas to address.</task> <format>Present as CMC documentation guidance organized by CTD sections.</format>"
      }
    ]
  }
}