Lot Numbering and Traceability Convention

RUO — Research Use Only. This document is a reference summary prepared for laboratory use. Compounds described are not approved for human or veterinary administration and have not been evaluated by the FDA for safety or efficacy.

This document describes the Nexphoria lot numbering system, sub-lot conventions, retention sample policy, traceability chain, and recall procedure. The format and record-keeping requirements align with ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) and 21 CFR Part 211.184 (Laboratory Records), adapted for research-use material. These policies apply to all Nexphoria catalog compounds.

1.0 Lot Number Format

Each Nexphoria production lot is assigned a unique lot number at the time of synthesis batch initiation. The format is:

NX-YYMM-NNN Where: NX = Nexphoria company prefix (fixed) YY = 2-digit year of manufacture (e.g., 26 = 2026) MM = 2-digit month of manufacture (01–12) NNN = 3-digit sequential lot number within that month (001–999) - = hyphen separator (literal character, part of format) Full format example: NX-2604-001

Lot number field descriptions
Field	Characters	Example	Notes
Prefix	NX	NX	Fixed; identifies Nexphoria as manufacturer
Year	YY (2 digits)	26	Last two digits of calendar year; unique ambiguity possible after year 2099 (outside system lifecycle)
Month	MM (2 digits)	04	Zero-padded; 01 = January through 12 = December
Sequence	NNN (3 digits)	001	Resets to 001 at the start of each calendar month; assigned in batch initiation order, not compound order

2.0 Worked Example

Lot NX-2604-001 decodes as follows:

Worked example: lot number NX-2604-001 decoded
Full lot number	NX-2604-001
Manufacturer	Nexphoria (NX)
Manufacture year	2026 (YY = 26)
Manufacture month	April (MM = 04)
Sequence within month	First lot of April 2026 (NNN = 001)
Interpretation	This was the first production batch initiated in April 2026 at Nexphoria.

3.0 Sub-Lot Suffix

When a single synthesis batch is divided into two or more physically separate vial fill runs (e.g., due to a change in fill line, vial type, or packaging date), each fill run is assigned a sub-lot suffix appended to the parent lot number.

Parent lot: NX-2604-001 Sub-lot A (fill 1): NX-2604-001-A Sub-lot B (fill 2): NX-2604-001-B Rules: - Sub-lot letters are uppercase alphabetic (A, B, C, ...) - Sub-lot designations are used only when vials from the same synthesis batch are physically separated before final packaging - All sub-lots share the parent lot COA with an addendum noting fill-specific parameters (fill date, vial count, operator) - COA Library entries for each sub-lot are distinct documents

Sub-lot suffix use cases
When used	Vial fill performed on two separate dates; fill performed using two different vial sizes (e.g., 5 mg and 10 mg from same bulk); transfer to off-site storage creates physically separate aliquots
When not used	Routine separation of vials within a single fill run for different order fulfillments; internal laboratory aliquoting by the customer
COA coverage	Sub-lots A and B both reference the parent lot's analytical data; fill-specific parameters (fill date, vial weights) are documented in the sub-lot addendum

4.0 Retention Sample Policy

Retention samples are held to permit re-testing in the event of a future customer complaint, stability investigation, or regulatory inquiry. Nexphoria's policy is consistent with 21 CFR 211.170 (Reserve Samples) adapted for research-use manufacturing [1, 2].

Retention sample policy details
Quantity retained	10% of each manufactured lot (by vial count), rounded up to a minimum of 2 vials per lot regardless of lot size
Storage condition	−20°C in a dedicated retention sample freezer, physically segregated from commercial inventory
Retention period	3 years from manufacture date, or 1 year beyond the lot expiry date, whichever is longer
Sample label	Marked "RETENTION SAMPLE — DO NOT DISTRIBUTE" with lot number, compound name, and retain-until date
Access control	Retention samples may be withdrawn only with written authorization from QA Manager; withdrawal documented in the lot retention log
Destruction	Disposal after retention period per institutional chemical waste procedure; destruction date and method recorded in retention log

5.0 Traceability Chain

Each finished lot can be traced from the customer's shipped vial back through the entire production sequence. The traceability chain comprises five linked records, each containing cross-references to adjacent records.

1 → Raw Material Lot Amino acid building blocks, resins, coupling reagents, and solvents. Each raw material is received with a vendor COA and assigned a Nexphoria raw material lot number (RM-YYMM-NNN). Certificates are filed in the raw material registry.
2 → Synthesis Batch Record Documents all raw material lot numbers consumed, synthesis parameters, operator IDs, in-process monitoring results (Kaiser test, resin loading check), and cleavage conditions. References raw material lot(s).
3 → Purification Fraction Record Preparative HPLC run parameters, column serial number, collected fraction volumes and purity by analytical check. Identifies which fractions were pooled for the release lot. References synthesis batch record.
4 → Fill and Lyophilization Lot Record Volume dispensed per vial, lyophilization cycle parameters (shelf temperature, condenser temperature, chamber pressure profile), post-lyophilization appearance, net weight per vial. References purification fraction record. The Nexphoria lot number (NX-YYMM-NNN) is assigned at this stage.
5 → Ship Lot Record Order number, customer identifier, vial serial numbers shipped, ship date, carrier tracking number, cold-pack configuration, and temperature indicator type and ID. References the fill lot record.

All five records are retained in electronic format with access-controlled backup. Paper originals (where applicable) are retained in the Nexphoria quality records archive for a minimum of 5 years from the ship date.

6.0 Recall Procedure

A lot recall or market withdrawal is initiated when a confirmed non-conformance is identified that may have been distributed to customers. Nexphoria's recall notification process follows the notification timeline requirements applicable to research-use chemical suppliers [2].

Recall procedure timeline and steps
Step	Timeline	Action
Non-conformance identification	T = 0	QA documents non-conformance in the deviation system; assigns deviation number; places remaining inventory on hold
Impact assessment	T + 4 hours	QA determines which lot numbers are affected; queries ship lot records to identify all affected customer orders
Customer notification	T + 24 hours	Written notice sent to all affected customers via email with: lot number(s) affected, nature of non-conformance, instructions for sequestration or return, and Nexphoria contact for questions
Return or disposition	T + 14 days	Customer returns affected material (prepaid return label provided) or confirms destruction with photographic documentation. Returned material is quarantined and disposed per chemical waste procedure.
Root cause analysis	T + 30 days	Written root cause analysis (CAPA) completed and filed. Customer notification of corrective action summary provided upon request.

Notification within 24 hours of a confirmed non-conformance is a firm requirement. Suspected non-conformances pending investigation do not automatically trigger customer notification; QA reviews available data within 4 hours to determine whether the non-conformance is confirmed before notification is issued.

7.0 References

[1] ICH Harmonised Guideline Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. (2000). International Council for Harmonisation. https://www.ich.org/page/quality-guidelines
[2] Code of Federal Regulations, Title 21, Part 211.184: Laboratory Records. U.S. Government Publishing Office. https://www.ecfr.gov/current/title-21

References · RUO — Research Use Only · Nexphoria