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Regulatory guidance articles
Regulatory context pages for teams translating guidance language into practical study design, records, and report boundaries.
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Regulatory Guidance
Regulatory and standards context for stability, validation, documentation, and method decisions.
AHAM AC-1 / AC-5 StandardsAHAM AC-1 and AHAM AC-5 are related air-cleaner standards, but they answer different evidence questions. AC-1 supports particulate CADR comparisons, while AC-5 addresses bioaerosol reduction in a chamber method.ASHRAE 241 Infection Risk MitigationASHRAE 241 helps building teams frame infectious-aerosol risk mitigation, while product teams still need method-specific evidence for bioaerosol efficacy, safety, and claim support.FDA Inhalation Device GuidanceFDA inhalation-device work starts by deciding which product frame applies: drug product, combination product, stand-alone device, accessory, or reusable delivery pathway.GLP vs. GMP: What's the Difference?GLP and GMP are not interchangeable: GLP protects the reliability of nonclinical study data, while GMP controls how regulated products are manufactured, tested, released, and documented.ICH Q1A(R2) Stability GuidelinesICH Q1A(R2) is the core stability-testing reference for many new drug substance and drug product registration packages.ISO 17025 Accreditation ExplainedISO/IEC 17025 accreditation is a laboratory-competence signal: it means an accreditation body has assessed a lab against defined requirements for valid testing or calibration work within a stated scope.