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Batch Traceability System

Overview

Batch traceability is the backbone of quality assurance in peptide manufacturing. A traceability system ensures that every vial can be mapped back to its complete production and testing history — from raw material lot numbers through synthesis, purification, QC testing, and final packaging.

At PeptideSourceHub, traceability is not an optional add-on. It is integrated into every production lot through:

  • Unique batch numbers assigned at synthesis initiation
  • Documented material flows at every processing step
  • QC data linkage — HPLC chromatograms, MS spectra, and COA data keyed to batch number
  • OEM batch number mapping for private-label customers

Lot Numbering System

Format: PSH-[YY]-[SEQ]-[MONTH][CHECK]

Component Example Meaning
PSH PSH Peptide Source Hub identifier
[YY] 26 Production year (2026)
[SEQ] 01837 Sequential production number
[MONTH] 08 Production month (August)
[CHECK] A Check character (alphabetic)

Example: PSH-26-01837-08A identifies batch 18,387 produced in August 2026, with integrity check character "A".

Batch Number Assignment

  • Assigned at synthesis initiation — not at packaging
  • Printed on COA, vial labels, kit box, and shipping documentation
  • Never reused — even for re-synthesis of the same peptide
  • Stored in immutable batch record database with full production audit trail

Traceability Chain

Every production lot follows a documented chain of custody through the manufacturing process:

Raw Materials → Synthesis → Purification → QC Testing → Packaging → Shipment
     │               │           │              │            │           │
     ▼               ▼           ▼              ▼            ▼           ▼
  Material      Synthesis   HPLC Run#      QC Batch#    Packaging    Shipping
  Lot #s        Batch#      Fraction#      COA ID       Lot#         Tracking#

Stage-by-Stage Traceability

Stage What Is Recorded Linked To
Raw Materials Amino acid derivative lot #, resin lot #, solvent batch #, reagent certificates Synthesis Batch #
Synthesis Operator, date, equipment ID, synthesis scale, coupling efficiency data Batch #
Purification Preparative HPLC run #, column ID, fraction collection details, solvent batch # Batch #
Lyophilization Freeze-dryer ID, cycle parameters, duration, vacuum profile Batch #
QC Testing Analytical HPLC run #, MS acquisition ID, Karl Fischer run #, COA ID Batch #
Vial Filling Filling date, operator, equipment ID, in-process weight checks Batch #
Packaging Kit assembly date, packaging lot, label batch, serial number range Batch # + Shipping Tracking #
Shipment Carrier, tracking #, export documentation, commercial invoice # Batch # + Order #

Documentation Audit Trail

For Every Batch, the Following Records Are Maintained:

  1. Batch Manufacturing Record (BMR) — Complete production history
  2. Analytical Data Package — Raw HPLC chromatograms, MS spectra, any additional testing
  3. Certificate of Analysis (COA) — Summarized quality data signed by QC reviewer
  4. Material Safety Data Sheet (MSDS) — Safety and handling information
  5. Packaging Record — Filling weights, vial counts, label verification
  6. Shipping Record — Carrier, tracking number, export documents

Record Retention

Record Type Retention Period
Batch Manufacturing Records Minimum 5 years
QC Analytical Data Minimum 5 years
COA Archive Indefinite
Shipping Records Minimum 3 years

OEM Batch Number Mapping

For OEM and private-label customers, PeptideSourceHub maintains a dual-numbering system:

Layer Number Example
Internal (PSH) PSH production batch number PSH-26-01837-08A
Customer-facing Brand's own lot number BRAND-A-2026-08

The OEM batch mapping provides:

  • Full traceability from customer label back to PSH manufacturing records
  • Customer-facing batch numbers that align with the buyer's own coding system
  • Quality documentation referencing both internal and customer-facing batch numbers
  • Retrospective traceability — if a customer reports an issue 12 months later, the batch can be traced back within minutes

Traceability in Practice

When a researcher or procurement manager contacts PeptideSourceHub with a batch number:

  1. ≤ 60 seconds: Batch record located in database
  2. ≤ 5 minutes: Full manufacturing history and QC data retrieved
  3. ≤ 1 business day: Complete documentation package (BMR, COA, MS spectra, HPLC chromatograms) available for re-issue

This capability is not theoretical — it's operational. Every batch record is maintained in a searchable database with QC documentation archived in both electronic and physical formats.