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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 signals laboratory competence. An accreditation body has assessed the lab against defined requirements for valid testing or calibration work within a stated scope.Unsubstantiated Antimicrobial and Air-Purification ClaimsFor air-treatment devices, antimicrobial products, and clean-air consumer goods, a 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 examines a laboratory's quality systems and selected study records. This article explains what that review can show and why sponsors should also review their own study documentation.