🇮🇳 ValiPro: Noida (UP) State & CDSCO Regulatory Validation Services
🇮🇳 ValiPro: Noida (UP) State & CDSCO Regulatory Validation Services
Ensure Flawless Compliance with the Mandatory Revised Schedule M and Meet the High Scrutiny of the CDSCO North Zone for Export and Special Product Licensing.
ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers operating in the Noida and Greater Noida industrial areas. Our documentation is built for full compliance with the rigorous standards of both the Uttar Pradesh Drugs Control Department and the CDSCO North Zone Office (Ghaziabad).
Key compliance pillars for Noida-based units include:
State Control (UP Drugs Control): The Uttar Pradesh Drugs Control Department is the primary authority for licensing, local GMP inspections, and enforcing the Drugs and Cosmetics Act, 1940, particularly Schedule M, within the state.
Central Control (CDSCO North Zone): Noida falls under the jurisdiction of the CDSCO North Zone (Ghaziabad), which coordinates:
Certificate of Pharmaceutical Product (CoPP) issuance for export.
Written Confirmation (WC) for API export (if applicable).
Joint Inspections with the State DCD for critical/specialized drugs (Vaccines, LVPs).
Revised Schedule M Mandate: Mandatory and time-bound adherence to the significantly upgraded Revised Schedule M, which aligns Indian GMP with international standards (WHO-GMP/PIC/S).
R&D and Specialization: Noida's proximity to the CDSCO HQ makes it a hub for specialized activities like clinical trials and new drug development, requiring validation reports to meet central technical standards.
🌟 Why Validation is Crucial in Noida
Noida's pharmaceutical landscape is under pressure from the central government's mandate to upgrade quality standards. Failure to meet the Revised Schedule M requirements for validation and qualification will result in strict regulatory action from both state and central authorities.
1. Compliance with Revised Schedule M (The Validation Mandate)
The most pressing regulatory requirement is the shift to the Revised Schedule M, which transforms GMP from a document-based checklist to a System-Based GMP approach. Validation is the cornerstone of this system.
Validation of Processes: The revised rules explicitly require the auditor to look for evidence of a validated process and validated analytical methods. This means prospective Process Validation (PPQ) must be completed before commercial launch, and Continued Process Verification (CPV) must be in place.
Qualification of Systems: All critical utilities (Water System, HVAC) and equipment must be formally Qualified (IQ, OQ, PQ), demonstrating suitability for their intended use.
Deadline: Small and Medium-sized Manufacturers (MSMEs) have a conditional extension to December 31, 2025, to comply with the Revised Schedule M. Completing the necessary validation and qualification protocols is the longest and most critical task in this compliance timeline.
2. CDSCO North Zone & Export Readiness
For Noida units targeting exports or critical domestic markets, the CDSCO North Zone review is essential:
CoPP/WC Applications: Validation documentation must adhere to WHO-GMP or ICH Q7 standards to support the quality claims required for CoPP (export) and Written Confirmation (WC) (API export to EU).
Joint Inspection: Licenses for critical products require a joint inspection between the Uttar Pradesh DCD and the CDSCO North Zone. Your validation dossier must satisfy the high technical standards of the central inspectorate.
3. UP DCD Licensing Requirements
The State Drugs Control Department relies on validation to assure the safety and efficacy of manufactured drugs for licensing purposes. Manufacturing Process Details and Analytical Methods submitted for license approval and renewal must be backed by scientifically robust Process Validation and Analytical Method Validation (AMV) reports.
🎯 Compliance Focus: Who We Support
We work with manufacturers operating in the Noida and Greater Noida industrial areas:
MSMEs: Requiring immediate Gap Analysis and documentation generation to meet the mandatory Revised Schedule M compliance deadline and avoid license suspension.
Export-Oriented Units (EOUs): Requiring validation documentation aligned with international standards to support CoPP/WC applications to the CDSCO North Zone.
New Drug/Specialty Product Units: Firms engaged in R&D or manufacturing of critical products (e.g., injectables, new fixed-dose combinations) that face high scrutiny from the CDSCO.
🛠️ Our Process Validation Services for Noida
We provide complete, scientifically sound, and documentation-intensive support tailored to the specific regulatory demands of the Uttar Pradesh DCD and the CDSCO North Zone.
ServiceNoida / UP DCD / CDSCO North Zone FocusRevised Schedule M PVDevelopment of Validation Master Plans (VMP), PPQ Protocols, and CPV Plans aligned with the latest Revised Schedule M and its QRM principles.ICH Q7 PV for APIsSpecialized validation protocols for API manufacturing and cleaning, ensuring compliance with ICH Q7 standards for export readiness.AMV & Utility QualificationPreparation of detailed Analytical Method Validation (AMV) reports (ICH Q2(R1)) and Utility Qualification reports (Water System, HVAC) essential for both state and central audits.Joint Audit ReadinessPre-audit and documentation review focused on the key inspection points for both the UP DCD and the CDSCO joint audit teams.
🤝 Get Started on Your Noida Validation
Ensure your process validation documentation is robust, complies with the mandatory Revised Schedule M, and meets the standards required by the CDSCO North Zone for national and international market access.
To receive a Technical Scope and Commercial Proposal tailored for your Noida project, simply provide:
Product: Active Pharmaceutical Ingredient (API) or Finished Formulation (e.g., tablet, injectable)
Target Status: Revised Schedule M Compliance / CoPP Application / License Renewal
Manufacturing Process: Overview of critical steps and control strategy
Timeline: Target audit date or submission date