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Pharmaceutical Label Material Compliance Checklist Generator
Configure your application + target markets + sterilization. Get an audit-ready checklist that maps each item to the regulatory anchor (USP <661>, 21 CFR § 211.122/.132, ISO 10993-1:2025, ICH Q3E, REACH SVHC, EMA/410/01 rev. 3) — for use in supplier qualification or QA-readiness review.
Compliance Checklist
Material Identification and Lot Traceability
Ref: 21 CFR § 211.122
Ref: 21 CFR § 211.122
Ref: USP <661.1>
Ref: USP <661>
Ref: USP <661.1>
Ref: paperindex governance baseline
USP and Extractables / Leachables
Ref: USP <661.1>
Ref: USP <661.2>
Ref: ICH Q3E
Ref: ICH Q3E + PQRI
21 CFR Part 211 Subpart G (FDA)
Ref: 21 CFR § 211.122
Ref: 21 CFR § 211.125
Ref: 21 CFR § 211.132
Ref: 21 CFR § 211.132(c)
Ref: 21 CFR § 211.134
Ref: 21 CFR § 211.137
ISO 10993-1:2025 Biological Evaluation (device-bound)
Ref: ISO 10993-1:2025
Ref: ISO 10993-5
Ref: ISO 10993-10/-23
Ref: ISO 17025 lab + 10993-1
European Union (REACH / EMA / TSE-BSE)
Ref: ECHA Candidate List
Ref: REACH Art. 33
Ref: EMA/410/01 rev. 3
Ref: EMA + EU MDR (where applicable)
Latin America (ANVISA-aligned)
Ref: ANVISA RDC
Ref: ANVISA labeling rules
Ref: ANVISA supplier audit
Cold-chain / Cryogenic Validation
Ref: Internal validation protocol
Ref: Internal validation protocol
Ref: Internal validation protocol
Ref: Internal validation protocol
Terminal Sterilization Compatibility
Ref: Internal validation
Ref: ISO 10993-7
Ref: Internal validation
Ref: Internal validation
Change-Control SOP (supplier deliverable)
Ref: paperindex baseline
Ref: paperindex baseline
Ref: Internal SOP
Ref: GxP supplier-quality expectation
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