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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 answer different air-cleaner evidence questions. AC-1 supports particulate CADR comparisons, while AC-5 addresses bioaerosol reduction using 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 GuidanceThe first step in FDA inhalation-device work is to identify the applicable product frame: 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.The Real Cost of Unsubstantiated Antimicrobial and Air-Purification ClaimsFor air-treatment devices, antimicrobial products, and clean-air consumer goods, the claim can create more regulatory exposure than the product itself. A product may be legal to sell; the claim may not be.What an EPA GLP Inspection Means for Study SponsorsAn on-site EPA FIFRA GLP inspection puts a laboratory's quality systems and study records under direct regulatory review. Sponsors should understand what that review covers, what evidence it tests, and what cannot be concluded while the written agency report remains pending.