Stratogene Pharma
audit/checklist
Today
Active
4
Ready
3
Open Dev.
1
Yield 30d
95.3%
OOS 30d
0.09%
🇮🇳 CDSCO Audit Mode|Stratogene Pharma Pvt. Ltd.|⏱ 00:00:00
GMP Inspection Checklist
Standards:
🇮🇳 Drugs & Cosmetics Act 1940
🇺🇸 21 CFR Parts 210 & 211
🇪🇺 EudraLex Volume 4
Section 1 of 9|0 of 53 items reviewed|2 findings
0%S1.1Batch records accessible for all closed batches
✅ COMPLIANT
148/148 batch records completeS1.2Batch records complete — no missing stage entries
✅ COMPLIANT
148/148 batches have all stage entriesS1.3All IPQA checks attributed to named operator
✅ COMPLIANT
2127/2127 checks attributed to operatorS1.4Batch records tamper-proof (SHA-256 integrity)
✅ COMPLIANT
SHA-256 applied to 148 closed batch records at closure time. Record hash displayed on eBR Page 12.S1.5eBR retrievable on demand
✅ COMPLIANT
148 eBRs accessible on demandSection S1: Batch Records
✅ 5 Compliant | 🟠 0 Attention | 🔴 0 Critical