article · Accreditation and Quality Assurance
Quality control laboratories in the pharmaceutical sector are increasingly required to demonstrate both technical competence and regulatory compliance. WHO Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL) and ISO/IEC 17025:2017 represent two prominent frameworks addressing these needs. While ISO/IEC 17025:2017 emphasizes accreditation, impartiality, and measurement traceability, GPPQCL emphasizes regulatory compliance, public health protection, and alignment with GMP principles. This review provides a narrative comparative analysis, highlighting similarities, differences, and integration strategies. Key areas include management system requirements, technical requirements, risk management, data integrity, decision rules, accreditation, and regulatory implications. A clause mapping table is presented to facilitate harmonization, and practical recommendations are offered for laboratories pursuing dual implementation. The analysis demonstrates that harmonized adoption enhances technical credibility, regulatory compliance, and public health assurance, enabling laboratories to meet both international and national standards.
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DOI: 10.1007/s00769-026-01732-7
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