/**
 * GxP Compliance Pack
 *
 * Good Practice Quality Guidelines covering Good Manufacturing
 * Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical
 * Practice (GCP). Applied when AI/ML operates in any regulated
 * pharma / biotech / medical-device / clinical-trial function.
 *
 * Standards referenced:
 *   - 21 CFR Parts 210-211 (US GMP)
 *   - 21 CFR Part 58 (US GLP)
 *   - 21 CFR Part 312 (US IND / GCP)
 *   - EU GMP Guide (EudraLex Vol 4) + Annex 11 (Computerised Systems)
 *   - ICH E6(R3) Good Clinical Practice (2024 revision)
 *   - ICH Q7 GMP for APIs; ICH Q9 Quality Risk Management; ICH Q10
 *     Pharmaceutical Quality System
 *   - OECD GLP Principles
 *   - 2022 EMA Reflection Paper on AI; 2023 EMA AI Guidance
 *   - ALCOA+ data integrity principles
 *
 * Current state (2026):
 *   - ICH E6(R3) GCP revision finalised 2024; implements "fit for
 *     purpose" modernisation for digital technologies including AI.
 *   - EU GMP Annex 11 governs computerised systems including AI-
 *     driven manufacturing QC and batch release.
 *   - GxP pairs with 21 CFR Part 11 (always).
 *
 * @connexum/ai-governance
 */
import { CompliancePack } from './index';
import { CategoryClassifiers } from '../classification/pack-driven-classifier';
/**
 * GxP (Good Practice - GMP/GLP/GCP) category classifiers.
 * Covers pharmaceutical manufacturing (GMP), laboratory studies (GLP),
 * and clinical trials (GCP) under FDA 21 CFR Parts 210/211/58/312.
 * REGULATED_RECORD and BATCH_DATA are LOG categories for evidence capture.
 */
export declare const GXP_CATEGORY_CLASSIFIERS: CategoryClassifiers;
export declare const GXP_PACK: CompliancePack & {
    categoryClassifiers: CategoryClassifiers;
    subjectKeyedCategories: string[];
};
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