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🇮🇳 CDSCO Audit Mode|Stratogene Pharma Pvt. Ltd.|⏱ 00:00:00

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Stratogene Pharma Pvt. Ltd. | Live compliance status

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🇮🇳 CDSCO
Drugs & Cosmetics Act 1940 | Schedule M (Revised 2023)
India
✅ Active
🇺🇸 FDA
21 CFR Parts 210 & 211 | 21 CFR Part 11
United States
✅ Active
🇪🇺 EMA
EudraLex Volume 4 | EU GMP Chapters 1-9 | Annexes 11 & 16
European Union
✅ Active
71
🟡 PREPARATION RECOMMENDED
🇮🇳 CDSCO Compliance Pack
📋Batch Records
133/133 batch records complete
20/20100%
Reg: Schedule M Cl.7View →
🔐Data Integrity
0 unique users in audit trail
20/20100%
Reg: —View →
⚠️Deviation Management
1 open | 0 overdue
13/2065%
Reg: —View →
⚡CAPA Effectiveness
1 actions past due date
10/2050%
Reg: —View →
🔧Equipment Calibration
COMP-A calibration due in 15 days — preventive action recommended
7/1070%
Reg: Schedule M Cl.5View →
✅IPQA Checks
1801 checks across 133 batches (avg 13.5/batch)
10/10100%
Reg: —View →
🔗Traceability & Recall
0/138 batches with raw material lot trace
4/1040%
Reg: Schedule M Cl.7View →
📅Self-Inspection Cadence
Last inspection 85 days ago — Schedule M requires monthly
Reg: Schedule M Clause 9View →
📜Licence & Regulatory Compliance
Licence MFG-2021-KA-04872 (Form 25) valid through 2027-12-31 — 570 days remaining
Reg: D&C Act 1940 | Rule 68BView →
5 Core QMS Elements — Coverage Status
QMS Element🇮🇳 CDSCO🇺🇸 FDA🇪🇺 EMA
Regulatory Philosophy
Risk-based quality system documentation
✅🟠❌
Data Integrity
ALCOA+ / Annex 11 compliance
✅✅🟠
Validation & Qualification
Process validation + CPV
🟠🟠🟠
Quality Risk Management
ICH Q9 QRM framework
🟠🟠❌
Out of Specification (OOS)
OOS investigation protocol
✅🟠🟠
Current Inspection
Status: 🟡 IN PROGRESS
Started: 05 Jun 2026
Findings: 2 Minor | 0 Critical
Continue Inspection →
Next Inspection Due
Due: 05 Aug 2026
57 days remaining
Frequency: MONTHLY
Last: 15 Mar 2026 — 82/100 ↘
View History →