Regulatory & Compliance

Registrations, Licences, Inspections & GxP Training

One compliance spine: product dossiers and variations per market, site licences and renewals, open inspection findings with CAPA links, and role-based GxP training qualification.

Active registrations

184

across 11 markets

Dossiers in review

avg 68 days in stage

Approved this year

Licences expiring ≤ 30 d

renewal action required

Training compliance

88%

23 overdue curricula

Registration & variation pipeline

Product	Market	Submission	Authority	Days in stage	Status
Omeprazole 10 mg/5 ml Eye Drops	Egypt	New registration	EDA	12	In Review
Omeprazole 20 mg Injection	Saudi Arabia	Variation Type IA	SFDA	21	Approved
Atorvastatin 500 mg Capsules	UAE	Variation Type II	GCC-DR	30	Pending
Amoxicillin 500 mg Sachet	Iraq	Renewal	WHO PQ	39	In Review
Metformin 20 mg Cream	Kenya	New registration	EDA	48	Rejected
Insulin Glargine 20 mg Injection	Egypt	Variation Type IA	SFDA	57	In Review
Losartan 250 mg Capsules	Saudi Arabia	Variation Type II	GCC-DR	66	Approved
Salbutamol 10 mg/5 ml Sachet	UAE	Renewal	WHO PQ	75	Pending
Metformin 250 mg Injection	Iraq	New registration	EDA	84	In Review

Site licences & renewals

GMP Certificate — Factory 1 (Solid Dose)
EDA · expires 2026-11-30 · 104 days
GMP Certificate — Factory 2 (Sterile)
EDA · expires 2026-09-08 · 21 days
Wholesale Distribution Licence — Cairo DC
EDA · expires 2027-02-14 · 180 days
Controlled Substances Permit
Ministry of Health · expires 2026-08-29 · 11 days
Export Licence — GCC markets
GCC-DR · expires 2027-05-01 · 256 days

Open inspection & audit findings

INSP-2026-03Major
Incomplete equipment cleaning logs on Line 3 for 4 batches
EDA GMP inspection — Factory 1 · CAPA due 2026-09-05
AUD-2026-11Minor
Audit-trail review for HPLC #3 not documented monthly
Internal audit — QC laboratory · CAPA due 2026-08-30
CUST-2026-07Major
Temperature mapping report for Cairo DC older than 3 years
Customer audit — Ibnsina Pharma · CAPA due 2026-10-12

GxP training qualification matrix

Production operators — Line 382%
SOP-PRD-014 rev. 6 (granulation) · 7 staff overdue — blocked from signing batch records
QC analysts96%
SOP-QC-221 (HPLC system suitability) · 1 staff overdue — blocked from signing batch records
QA reviewers100%
Data integrity & ALCOA+ refresher · 0 staff overdue
Warehouse GxP staff74%
Cold-chain handling & FEFO picking · 11 staff overdue — blocked from signing batch records
Packaging line staff88%
Serialisation & aggregation (GS1) · 4 staff overdue — blocked from signing batch records

Records & transactions

Regulatory submission · GxP training record

No records posted in this module yet. Use “New record” to create one — it is saved to the shared database with an audit entry, recomputed into the KPIs and alarms, and fed to the AI agents as live context.