Module 3.2.A Appendices & 3.2.R Regional Information — GLPI-103
| Field | Value |
|---|---|
| Document ID | M3-AR |
| Version | 2.0 (expanded) |
| Standard | ICH M4Q §3.2.A / §3.2.R · Q5A(R2) · Q7 |
| Confidentiality | Confidential |
[MOCK — deep-knowledge assumption]Appendices and regional quality information for the GLPI-103 drug substance and products.
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | CMC / Reg-CMC | Initial |
| 2.0 | 2026-06-30 | CMC / Reg-CMC | Expanded — facilities, adventitious agents, SNAC novel-excipient qualification, regional content |
3.2.A.1 Facilities & Equipment
Named GMP facilities perform (i) drug-substance solid-phase synthesis, preparative-HPLC purification and lyophilisation; (ii) aseptic fill-finish of the IV product (Grade A/B cleanrooms, validated isolator/RABS); and (iii) solid-dose manufacture (direct compression) of the oral tablet. Utilities (WFI, clean steam, HVAC) and equipment are qualified (IQ/OQ/PQ); uni-directional product/personnel flow and segregation prevent cross-contamination; a multi-product matrix with cleaning-validation (carry-over limits) is in place.
3.2.A.2 Adventitious Agents Safety Evaluation (Q5A(R2))
GLPI-103 is a chemically synthesised peptide of non-biological origin, minimising viral/TSE risk; no animal-derived raw materials are used in synthesis (vegetable-origin or synthetic reagents; TSE/BSE-free declarations on file for any ruminant-contact material). Microbial control is assured by bioburden and bacterial-endotoxin limits on the drug substance and by the sterilising-grade filtration and aseptic process for the IV product.
3.2.A.3 Novel Excipients — SNAC (oral permeation enhancer)
The oral product contains sodium N-[8-(2-hydroxybenzoyl)amino]caprylate (SNAC) as a functional permeation enhancer. Although SNAC has regulatory precedent (oral semaglutide), it is controlled here to a full internal specification (identity, assay, related substances, residual solvents, heavy metals) with its own characterisation and non-clinical safety qualification (the toxicology program qualified the SNAC level used; M4-2.3 §6); stability of SNAC within the tablet is covered by the drug-product stability programme (M3-STAB).
3.2.R Regional Information
| Region | Regional quality content |
|---|---|
| FDA (US) | Executed/representative batch records; method-validation packages; comparability protocols; Certificates of Analysis; container-closure & device (pen) information |
| EMA (EU) | Qualified Person (QP) declaration; process-validation scheme; site GMP certificates; TSE compliance (EDQM); novel-excipient (SNAC) regional dossier |
| MFDS (KR) | Korean GMP (KGMP) documentation; local DMF/registration for the active and SNAC; import testing/local release as required |
3.3 Literature References
Pharmacopoeial monographs (Ph.Eur. / USP-NF / KP) for excipients and general methods; ICH Quality guidelines (Q1A(R2), Q1B, Q2(R2), Q3A/B/C/D, Q5A(R2), Q5C, Q5E, Q6B, Q7, Q8(R2), Q9(R1), Q11, Q12, Q14); and peptide-CMC and permeation-enhancer literature as cited in Module 3.