CDSCO ICH Q2R1 Analytical Method Validation Compliance Checklist
This checklist covers compliance requirements under Drugs & Cosmetics Act 1940 and applicable Indian regulations for manufacturing operations. Non-compliance can result in cancellation of manufacturing licence and penalties up to ₹10 lakh under Section 27 of the Drugs & Cosmetics Act 1940.
- Industry: Manufacturing
- Frequency: Quarterly
- Estimated Time: 25-35 minutes
- Role: Analytical Development Manager
- Total Items: 20
- Compliance: Drugs & Cosmetics Act 1940, Drugs & Cosmetics Rules 1945 Schedule M, CDSCO GMP Guidelines, WHO TRS 986
CDSCO Licence & GMP Registration
Verify Drugs & Cosmetics Act 1940 manufacturing licence and Schedule M GMP registration.
- Is the manufacturing licence (Form 25 or 28) valid and current for all products manufactured?
- Is a qualified Technical Staff person (B.Pharm or equivalent) appointed and approved by the licencing authority?
- Is the manufacturing site registered with CDSCO for export and does it comply with Schedule M GMP requirements?
- Attach photo of manufacturing licence Form 25/28, Technical Staff appointment, and CDSCO registration:
Premises, Equipment & Utilities Compliance
Verify GMP premises qualification, utilities, and equipment calibration per Schedule M.
- Are all premises, equipment, and utilities qualified per Schedule M GMP and validation master plan?
- Is the water system (Purified Water or WFI) tested per pharmacopoeial limits with records maintained?
- Are all analytical instruments calibrated with valid calibration certificates on file?
- Attach photo of cleanroom qualification, water system test results, and calibration certificates:
Batch Records & OOS Investigation
Verify BMR completeness, OOS investigation compliance, and QA release per Schedule M.
- Is the batch manufacturing record (BMR) complete, reviewed by QA, and available for every batch?
- Is the out-of-specification (OOS) procedure followed and all OOS investigations documented?
- Overall cGMP production and QA compliance status:
- Attach photo of batch manufacturing record, OOS investigation file, and QA release stamp:
CAPA, Complaints & Pharmacovigilance
Verify CAPA system effectiveness and ADR/pharmacovigilance compliance per CDSCO requirements.
- Is the CAPA system effectively identifying, investigating, and preventing recurrence of quality issues?
- Are product complaints investigated and Adverse Drug Reactions (ADRs) reported to CDSCO PvPI portal?
- Number of open CAPAs beyond target closure date:
- Quality Director or Head of Quality certification:
Corrective Actions & Inspector Sign-Off
Document all deficiencies and assign corrective actions. POPProbe auto-assigns these to team members, generates a signed PDF report instantly, and tracks compliance status across all locations. -> Start free, no credit card required
- List all deficiencies identified in this inspection:
- Overall compliance status?
- Corrective actions assigned to (name and department):
- Inspector digital signature and date:
Related Manufacturing Checklists
- CDSCO IP & Schedule M Dissolution Testing Compliance Checklist
- CDSCO Schedule M & IP Microbial Limits Testing Compliance Audit
- CDSCO Schedule M Container Closure Integrity & Compatibility Audit
- CDSCO Schedule M Ophthalmic Product Manufacturing GMP Audit
- CPCB Red Category Industry Environmental Compliance Audit Checklist
- CPCB Orange Category Industry Environmental Compliance Audit
- CPCB Green Category Industry Environmental Compliance Checklist
- CPCB Indoor Air Quality Workplace Guidelines Compliance Audit India
Related Pharmaceutical Checklists
- CDSCO Schedule M GMP Pharmaceutical Manufacturing Annual Audit - FREE Download
- CDSCO Schedule M Clause 3 Premises & Equipment GMP Inspection - FREE Download
- CDSCO Schedule M Clause 11 Production Controls GMP Compliance Audit - FREE Download
- CDSCO Schedule M Clause 14 QC Laboratory Controls Compliance Audit - FREE Download
- CDSCO Schedule M Batch Manufacturing Record Completeness Audit - FREE Download
- CDSCO Schedule M Pharmaceutical Water System Validation & Monitoring - FREE Download
- CDSCO Schedule M Cleanroom Environmental Monitoring Audit - FREE Download
- CDSCO Schedule M Process Validation & Equipment Qualification Audit - FREE Download
- CDSCO Schedule M CAPA System Effectiveness Verification Audit - FREE Download
- CDSCO Schedule M Out-of-Specification Investigation Checklist - FREE Download
Why Use This CDSCO ICH Q2R1 Analytical Method Validation Compliance Checklist?
This cdsco ich q2r1 analytical method validation compliance checklist helps manufacturing teams maintain compliance and operational excellence. Designed for analytical development manager professionals, this checklist covers 20 critical inspection points across 5 sections. Recommended frequency: quarterly.
Ensures compliance with Drugs & Cosmetics Act 1940, Drugs & Cosmetics Rules 1945 Schedule M, CDSCO GMP Guidelines, WHO TRS 986. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the CDSCO ICH Q2R1 Analytical Method Validation Compliance Checklist cover?
This checklist covers 20 inspection items across 5 sections: CDSCO Licence & GMP Registration, Premises, Equipment & Utilities Compliance, Batch Records & OOS Investigation, CAPA, Complaints & Pharmacovigilance, Corrective Actions & Inspector Sign-Off. It is designed for manufacturing operations and compliance.
How often should this checklist be completed?
This checklist should be completed quarterly. Each completion takes approximately 25-35 minutes.
Who should use this CDSCO ICH Q2R1 Analytical Method Validation Compliance Checklist?
This checklist is designed for Analytical Development Manager professionals in the manufacturing industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.