CDSCO Schedule M Stability Testing Program Audit 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: Stability Manager
- Total Items: 20
- Compliance: Drugs & Cosmetics Act 1940, Drugs & Cosmetics Rules 1945 Schedule M, CDSCO GMP Guidelines, WHO TRS 986 GMP
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 Schedule M Change Control Procedure Compliance Audit
- CDSCO Schedule M Annual Product Quality Review APR Audit
- CDSCO Schedule M Approved Supplier Audit & Qualification Checklist
- CDSCO Schedule M & Drugs Rules Label Compliance Audit Checklist
- Drugs & Cosmetics Act 1940 Pharmaceutical Import Compliance Checklist
- AYUSH GMP Guidelines Ayurvedic Manufacturing Quality Audit
- CDSCO Biologicals Guidelines Vaccine & Biologics Manufacturing Audit
- Air & Water Acts SPCB Consent to Operate Compliance Checklist
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 Schedule M Stability Testing Program Audit Checklist?
This cdsco schedule m stability testing program audit checklist helps manufacturing teams maintain compliance and operational excellence. Designed for stability 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 GMP. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What is a CDSCO Schedule M Stability Testing Program Audit Checklist?
A CDSCO Schedule M Stability Testing Program Audit Checklist is a standardized inspection form used by stability manager to ensure consistent manufacturing operations. It contains 27 inspection points organized into 5 sections. FREE PDF - CDSCO Schedule M Stability Testing Program compliance checklist for Indian operations. Covers Drugs & Cosmetics Act 1940 requirements. Download FREE template.
How often should I use this manufacturing checklist?
This checklist is designed to be completed quarterly. Regular use ensures compliance with Drugs & Cosmetics Act 1940 and Drugs & Cosmetics Rules 1945 Schedule M and helps identify issues before they become problems.
Can I download this CDSCO Schedule M Stability Testing Program Audit Checklist as a PDF?
Yes, you can download this checklist as a FREE PDF for printing or offline use. The checklist includes 27 fields across 5 sections and typically takes 25-35 minutes to complete.
What compliance standards does this checklist cover?
This checklist helps ensure compliance with Drugs & Cosmetics Act 1940, Drugs & Cosmetics Rules 1945 Schedule M, CDSCO GMP Guidelines, WHO TRS 986 GMP. Following these standards protects your organization and ensures best practices.
How do I complete this manufacturing inspection checklist?
Begin by completing the header fields for Facility / Unit Name, Inspection Date, Inspector Name & Designation, and Factory/Registration Number. Work through each of the 5 sections, marking items Yes or No as applicable. Add notes for any issues found. Finally, complete the footer fields and add your signature. The entire process takes approximately 25 to 35 minutes.
What are the key sections in this manufacturing checklist?
This manufacturing checklist is organized into 5 key sections: CDSCO Licence & GMP Registration, Premises, Equipment & Utilities Compliance, Batch Records & OOS Investigation, CAPA, Complaints & Pharmacovigilance, Corrective Actions & Inspector Sign-Off. Each section contains specific inspection points that stability manager must verify. The structured layout ensures nothing is missed during manufacturing inspections and makes the process efficient, typically taking 25-35 minutes to complete.
Who should use this CDSCO Schedule M Stability Testing Program Audit Checklist?
This checklist is primarily designed for stability manager working in manufacturing operations. However, it is also valuable for quality assurance teams, safety officers, compliance managers, and supervisors who need to verify that manufacturing standards are being met. Organizations of all sizes can benefit from using this CDSCO Schedule M Stability Testing Program Audit Checklist to maintain consistency and accountability.