🇮🇳 ValiPro: Delhi NCR (CDSCO HQ & State) Validation Services

Ensure Complete Compliance with the CDSCO's Strictest Requirements and the Delhi Drugs Control Department's Local Manufacturing Norms, especially under the Revised Schedule M.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers operating in Delhi and the surrounding NCR regions (which fall under the CDSCO North Zone). Our documentation is built for full compliance with the rigorous standards of both the CDSCO (central authority) and the respective State Drugs Control Departments (local authority).

Key compliance pillars for Delhi NCR-based units include:

• Central Control (CDSCO Headquarters): Located in New Delhi, this is the highest national authority. It is responsible for new drug approval, clinical trials, and licensing of specialized/critical drugs (LVPs, Vaccines, Biologics).

• State Control (Delhi Drugs Control Department): The local department regulates the manufacture and sale of drugs within the NCT of Delhi, granting licenses and enforcing local inspections based on the Drugs and Cosmetics Act.

• Revised Schedule M Mandate: Strict and time-bound adherence to the significantly upgraded Revised Schedule M of the Drugs & Cosmetics Act, which aligns Indian GMP with WHO-GMP/PIC/S standards.

• Specialized Product Focus: Due to proximity to the CDSCO HQ, manufacturers of specialized and novel products often face higher scrutiny.

🌟 Why Validation is Crucial in the Delhi NCR Hub

The Delhi NCR environment demands the highest level of regulatory readiness, as manufacturing sites are subject to inspection from both the State Drugs Control Department and the highly specialized inspection teams coordinated by the CDSCO Headquarters.

1. The Dual Regulatory Structure

AuthorityKey Functions Related to ValidationCDSCO (Headquarters/North Zone)New Drug Approval, Clinical Trials, Licensing of Critical Drugs (Vaccines, LVPs, Biologics), COPP (Certificate of Pharmaceutical Product) issuance, and coordinating joint inspections with the State DCD for certain licenses.Delhi Drugs Control DepartmentGranting/Renewal of Manufacturing Licenses (for general categories), enforcing Schedule M through routine inspections, and requiring detailed Technical Staff, Equipment, and Formulation documentation.

2. Compliance with Revised Schedule M

The most critical immediate compliance challenge is the Revised Schedule M. This revision elevates validation to a lifecycle approach and mandates the integration of Quality Risk Management (QRM).

• Lifecycle Validation: Manufacturers must move beyond single-point validation to a three-stage lifecycle, incorporating Process Design (Stage 1), Process Qualification (Stage 2), and Continued Process Verification (Stage 3).

• Data Integrity (ALCOA+): The new rules strictly enforce ALCOA+ principles for all validation and quality records, requiring robust, validated electronic systems (e.g., compliant with 21 CFR Part 11/GAMP principles for data capture and storage).

• Joint Inspections: The Drugs Rules, 1945, now mandate that the manufacturing establishment is inspected jointly by the Central Government and the State Government concerned before a manufacturing license is granted. This means your validation documentation must satisfy both central (CDSCO) and state (DCD) inspectors simultaneously.

3. Key Validation Documentation for Licensing

To obtain or renew a license from the Delhi Drugs Control Department, the technical documentation must be comprehensive and scientifically supported:

• List of Equipment and Machineries: Must be accompanied by documented Qualification (IQ/OQ/PQ) reports.

• List of Formulations: Must include product information, which requires Process Validation summaries proving quality and efficacy.

• List of Technical Staff: They must be trained on, and adhere to, validated procedures (training records linked to validation SOPs).

🎯 Compliance Focus: Who We Support

We work with manufacturers operating in the Delhi NCR region:

• Specialized Drug Manufacturers: Requiring specialized validation (e.g., Media Fill, Terminal Sterilization) to meet the stringent licensing requirements of the CDSCO for critical products.

• Schedule M Upgrade: Companies requiring a complete overhaul of their Quality System and Validation Documentation to meet the Revised Schedule M deadline.

• Export-Oriented Units (EOUs): Requiring validation documentation aligned with WHO-GMP/PIC/S to support CoPP applications through the CDSCO.

• New License Applicants: Needing comprehensive technical dossiers to successfully navigate the new CDSCO/State DCD joint inspection mandate.

🛠️ Our Process Validation Services for Delhi NCR

We provide complete, scientifically sound, and documentation-intensive support tailored to the complex dual regulatory demands of the Delhi NCR.

ServiceDelhi NCR / CDSCO HQ / Revised Schedule M FocusRevised Schedule M PVDevelopment of Validation Master Plans (VMP), PPQ Protocols, and CPV Plans aligned with the revised Schedule M and its emphasis on QRM.AMV & Finished Product TestingPreparation of detailed Analytical Method Validation (AMV) reports (ICH Q2(R1)) to support the required Specifications and Analytical Procedures for regulatory submissions.Critical System ValidationHVAC, Water System, and Computer System Validation (CSV) to meet the strict GMP and Data Integrity requirements of the central authority.Joint Inspection ReadinessPre-audit and documentation review focused on the key inspection points for both the CDSCO and the local DCD joint audit teams.

🤝 Get Started on Your Delhi NCR Validation

Ensure your process validation documentation is robust, meets the stringent requirements of the CDSCO Headquarters for central approvals, and complies fully with the Revised Schedule M enforced by the local Drugs Control Departments.

To receive a Technical Scope and Commercial Proposal tailored for your Delhi NCR project, simply provide:

• Product: Dosage form (e.g., Injectable, Vaccine, tablet) and Batch Size

• Target Status: Revised Schedule M Compliance / New Product Approval / CoPP Application

• 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.