🇮🇳 ValiPro: Roorkee (Uttarakhand) DCD & CDSCO Validation Services
Ensure Flawless Compliance with the Mandatory Revised Schedule M and Meet the Scrutiny of the Uttarakhand Drugs Control Department and CDSCO North Zone for Quality Assurance.
ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers operating in the Roorkee industrial area. Our documentation is built for full compliance with the rigorous standards of both the Drugs Controlling and Licensing Authority, Uttarakhand (DCD) (state authority) and the CDSCO North Zone Office (central authority, based in Ghaziabad, with jurisdiction over Uttarakhand).
Key compliance pillars for Roorkee-based units include:
State Control (Uttarakhand DCD): The primary authority for granting and renewing manufacturing licenses, enforcing routine local inspections, and ensuring compliance with the state's implementation of the Drugs and Cosmetics Act, 1940, particularly the Revised Schedule M.
Central Control (CDSCO North Zone): The CDSCO North Zone coordinates central functions, including Certificate of Pharmaceutical Product (CoPP) issuance for export and Joint Inspections with the State DCD for specialized drugs (e.g., 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). Roorkee units must urgently upgrade their systems to avoid regulatory action.
🌟 Why Validation is Crucial in Roorkee
The immediate and most critical challenge for Roorkee manufacturers is the mandatory transition to the Revised Schedule M. Validation is the scientific core of the new compliance system that auditors will target.
1. Compliance with Revised Schedule M (The Validation Mandate)
The Revised Schedule M requires all manufacturers to shift from a documentation-based approach to a scientifically sound System-Based GMP. This impacts every aspect of the facility:
System Validation: Auditors will now look for evidence of a validated process, validated cleaning procedures, and validated analytical methods. The documentation must be robust and auditable.
Qualification: All critical utilities (like HVAC and Water Systems) and production equipment must undergo a complete Qualification Lifecycle (DQ, IQ, OQ, PQ).
Data Integrity (ALCOA+): Validation documentation must ensure ALCOA+ principles are followed, extending to the use of validated computerized systems for all quality records.
Deadline: Small and Medium-sized Manufacturers (MSMEs) in Roorkee (like those throughout India) have a conditional extension until December 31, 2025, to achieve full compliance with the Revised Schedule M. Failure to comply can lead to license suspension or cancellation by the Uttarakhand DCD.
2. Uttarakhand DCD Licensing and Inspection
The local DCD uses validation reports as documented proof of a manufacturer's capacity to produce safe and effective drugs.
License Renewal: Renewal of a Manufacturing License requires the submission of updated technical dossiers, which must include current and scientifically sound Process Validation Reports (PVRs) and Analytical Method Validation (AMV) data.
Inspection Focus: DCD inspections under the revised rules will focus heavily on Facility Upgrades (e.g., proper segregation, smooth washable surfaces) and the completeness of Validation Protocols and Reports.
3. CDSCO North Zone Scrutiny (Export & Critical Products)
For Roorkee units aiming for exports or specialized domestic licenses, the documentation must satisfy the CDSCO's higher standards:
CoPP Support: To obtain the Certificate of Pharmaceutical Product (CoPP), validation reports must align with WHO-GMP standards, which are largely integrated into the Revised Schedule M.
Joint Inspections: Critical drug manufacturing licenses require joint inspections by the State DCD and the CDSCO North Zone.
🎯 Compliance Focus: Who We Support
We work with manufacturers operating in the Roorkee region:
MSMEs: Requiring an urgent Gap Analysis against the Revised Schedule M and a strategic, phased plan for validation and facility upgrades before the December 2025 deadline.
CDMOs/Third-Party Units: Needing robust, audit-ready validation packages that satisfy their clients' diverse regulatory demands (domestic Schedule M and international GMP).
New License Applicants: Seeking to compile a comprehensive technical dossier to successfully pass the DCD/CDSCO inspection for a new manufacturing license.
🛠️ Our Process Validation Services for Roorkee
We provide complete, scientifically sound, and documentation-intensive support tailored to the local regulatory demands and the national upgrade mandate.
ServiceRoorkee / Uttarakhand DCD / Revised Schedule M FocusSchedule M Gap AnalysisComprehensive review of existing systems against the Revised Schedule M (2023) to prioritize validation and infrastructure upgrades.Revised Schedule M PVDevelopment of Validation Master Plans (VMP) and PPQ Protocols aligned with the revised Schedule M and QRM principles.Utility QualificationComplete Water System Validation (purified, WFI) and HVAC Qualification reports, mandatory for Schedule M compliance in a mountainous environment.Cleaning ValidationDesigning and reporting cleaning validation studies to prevent cross-contamination, a key focus area in Schedule M inspections.
🤝 Get Started on Your Roorkee Validation
Ensure your process validation documentation is robust, complies with the mandatory Revised Schedule M, and meets the standards required by the local Uttarakhand DCD and the CDSCO North Zone.
To receive a Technical Scope and Commercial Proposal tailored for your Roorkee project, simply provide:
Product: Dosage form (e.g., tablet, capsule, liquid) and Batch Size
Target Status: Revised Schedule M Compliance / License Renewal / New Product Approval
Manufacturing Process: Overview of critical steps and control strategy
Timeline: Target audit date or submission date
Existing Data: Current validation master plan or any recent regulatory deficiency letters