New Guide for Standard Guide for Verification of a Conformity Assessment Supporting Medication Supply Chains
1. Scope
1.1 This document is proposed as a Guide under ASTM definitions. It provides methodologies and recommended practices (“should” guidance rather than mandatory “shall” requirements) for establishing end-to-end traceability of medications—from raw material and active pharmaceutical ingredient (API) sourcing through formulation, packaging, transport, and distribution. The Guide focuses on document-based verification, including the tracking and authentication of Certificates of Analysis (COAs), Certificates of Conformity (CoCs), batch production records, serialization data, and related regulatory and trade documents. It does not prescribe specific manufacturing process controls or pharmaceutical test methods, which remain governed by existing FDA, ISO, ICH, USP/EP/JP, and national regulatory standards.
1.2 This Guide provides a technology-neutral and outcome-oriented framework. It defines what information and capabilities should be in place to verify supply chain claims but allows flexibility in how organizations implement traceability and authentication systems, including the use of distributed ledgers, traditional databases, digital signatures, QR codes, RFID, or other identifier technologies.
1.3 This Guide outlines recommended practices to trace medication components and finished products from API synthesis and excipient sourcing through formulation, filling, packaging, serialization, and distribution. Traceability includes mapping material flows, documenting each transformation step, and establishing a transparent, auditable chain of custody for all batches and serialized units.
1.4 This Guide provides recommended practices for authenticating critical documents and supply chain components using tamper-evident techniques such as secure COAs, digitally signed CoCs, validated batch records, and provenance metadata. These practices support confirmation of product legitimacy and document integrity prior to import, export, or downstream distribution.
1.5 This Guide outlines a verification process for comparing supply chain records against applicable business logic, regulatory expectations, and compliance criteria. Verification includes identifying anomalies or inconsistencies that may indicate fraud, diversion, adulteration, or non-compliance—such as mismatches between declared origin and procurement data, incomplete GMP documentation, deviations in manufacturing records, or discrepancies in serialization and traceability data.
1.6 This Guide establishes recommended oversight practices for regulators, authorized trading partners, and accredited third parties, including inspections, laboratory verification, digital record audits, and post-market monitoring. These activities support continuous confirmation of compliance with the traceability, authentication, and documentation integrity requirements described in this Guide.
1.7 Although the primary focus is medications and their components, the principles described may also be applied to related pharmaceutical products, including APIs, intermediates, excipients, compounded preparations, and regulated health products that require documentation-based verification of origin, chain-of-custody, and authenticity claims. This Guide is intended to complement existing pharmaceutical quality and serialization regulations such as DSCSA and the EU Falsified Medicines Directive.
1.8 This Guide is intended for use by manufacturers of medications and component materials; contract manufacturers and packagers; distributors, importers, and exporters involved in pharmaceutical supply chains; accredited laboratories and certification bodies performing product testing or supply chain audits; and regulatory, customs, or procurement authorities requiring assurance of product origin, quality, and compliance, including adherence to global anti-counterfeiting, anti-diversion, and drug-safety regulations.
1.9 This Guide addresses documentation and data traceability only. It does not establish or revise pharmaceutical performance requirements, prescribe manufacturing techniques, or define GMP process control standards. It assumes that medications meet applicable quality requirements under relevant FDA, ICH, ISO, or pharmacopoeial standards and provides guidance on how to trace and substantiate those claims. While physical identifiers such as serialization codes, lot numbers, QR codes, or RFID tags are recommended to support traceability, no specific technology platform is mandated, provided that secure, auditable records are maintained.
Keywords
Medications; Pharmaceuticals; Supply Chain Traceability; Certificate of Authenticity; Certificate of Conformity; COA Verification, DSCSA; Falsified Medicines Directive; Counterfeit Prevention; Documentation Verification; Conformity Assessment;
Rationale
Standard Guide is needed for governemnt and commerce to work together in adopting a conformity assessment scheme to trace medications and their components in the global supply chain
