Lot Attribute

A lot attribute is a property of one specific lot of one specific material, distinct from the material master (which is per-material) and from the batch record (which is per-batch). Examples: assay 99.4% on Lot A24-1183 of acetylsalicylic acid; moisture 0.6% on Lot B25-0907; supplier lot SUP-44521; manufacture date 2025-08-15; certificate-hash SHA-256 fingerprint. Without lot attributes, dispensing is a guess, potency correction is impossible and recall is approximate.

• Captured at receipt (from CoA), at QC release (from in-house testing), and during in-process events (from retest).
• Versioned if an attribute is re-determined — the lot may have an assay-at-receipt and an assay-at-retest, both retained.
• Used live by the dispensing engine: 'charge 10.00 kg ASA' becomes '10.06 kg' because the lot assay is 99.4%.
• Carried through genealogy — lot attributes of every contributing lot are queryable from the finished product.
• Surface on the eBR — auditors see the precise lot attributes used in the calculations they review.

• CoA parsing — structured CoAs (XML, signed JSON) ingest directly into attribute fields; PDF CoAs require manual entry or OCR with verification.
• QC release — in-house test results post to the lot record as attributes when QC disposition is Released.
• Retest events — new attribute version recorded; prior version retained for traceability.
• Manual edits require e-signature, rationale and audit trail under Part 11.
• Bulk import (for historical migration) is permitted with documented validation but never used in steady state.

• Potency-corrected dispensing — assay attribute drives the charge calculation in real time.
• Expiry enforcement — expiry attribute prevents dispensing of expired lots; warns on near-expiry lots.
• Retest enforcement — retest-date attribute prevents use beyond interval without QC re-release.
• Specification-based picking — lot attributes (e.g. particle size) match recipe requirements (e.g. needs D50 < 50µm).
• Recall queries — 'every lot with moisture > 0.8% used in product P26-04500–P26-04520' resolves in seconds.

• Treating CoA values as free-form text instead of typed attributes — calculations cannot use them.
• Overwriting prior attribute values during retest — lose the history needed for trend analysis.
• No audit trail on attribute edits — Part 11 violation; investigator cannot reconstruct.
• Per-lot attributes stored on the material master — pollutes the master with lot-specific noise.
• Manual entry of every attribute when supplier CoAs are machine-readable — wasted effort, transcription errors.
• Failing to capture supplier lot alongside internal lot — recall scope across suppliers becomes impossible.

• Pharma API — assay (HPLC), water (Karl Fischer), residual solvents (GC), heavy metals (ICP-MS) as per-lot attributes.
• Biopharma — bioactivity titre, host-cell protein, endotoxin per lot.
• Medical device components — dimensional measurements, surface-roughness Ra, biocompatibility ISO 10993 attributes.
• Food ingredients — moisture, fat, protein, allergen test results, pathogen screening results.
• Cosmetics — colour Lab values, viscosity at 25°C, perfume strength index.
• Cannabis — cannabinoid profile (THC, CBD, CBG…), terpene profile, residual solvents, pesticide residue per lot.