🇮🇳 ValiPro: Faridabad (Haryana) State & Central Regulatory Validation Services

The pharmaceutical regulatory environment in Faridabad, Haryana, India, is governed by a dual control mechanism involving the state and central regulatory bodies. Faridabad is a key industrial city bordering the National Capital Region (NCR).

🇮🇳 ValiPro: Faridabad (Haryana) State & Central Regulatory Validation Services

Ensure Flawless Compliance with the Haryana State Drugs Control Department and CDSCO North Zone Requirements, particularly for export-oriented API and Formulation units.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers operating in Faridabad, ensuring full alignment with the rigorous standards of both the Haryana State Drugs Control Department (DCD) and the CDSCO North Zone (Ghaziabad).

Key compliance pillars for Faridabad-based units include:

• State Control (Haryana DCD): The primary authority for licensing, local GMP inspections, and enforcing the Drugs and Cosmetics Act, 1940 and Rules, 1945 (especially Schedule M) within Haryana.

• Central Control (CDSCO North Zone): Faridabad falls under the jurisdiction of the CDSCO North Zone (Ghaziabad). This office is crucial for coordinating Certificate of Pharmaceutical Product (CoPP) and Written Confirmation (WC) issuance (vital for API exports to the EU) and conducting joint specialized inspections.

• Revised Schedule M: Mandatory and time-bound adherence to the significantly upgraded Revised Schedule M, which elevates the requirement for documented validation across all manufacturing sites.

• Export Focus: Many units in Faridabad, particularly those producing Active Pharmaceutical Ingredients (APIs), must maintain WHO-GMP/ICH Q7 standards to facilitate global trade.

🌟 Why Validation is Crucial in Faridabad

Faridabad's manufacturing sites must demonstrate quality compliance to two major authorities. The shift to the Revised Schedule M requires all manufacturers (especially MSMEs) to immediately upgrade their validation programs to meet global lifecycle standards.

1. Compliance with Revised Schedule M (Validation Mandate)

The Revised Schedule M mandates a system-based approach where validation is the central proof of compliance.

• Validation and Qualification: The revised norms explicitly require:

  • Qualification (DQ, IQ, OQ, PQ) of all equipment and utilities.

  • Process Validation (PV) must be conducted and documented to confirm that manufacturing processes consistently produce a product meeting its intended specifications.

• Quality Risk Management (QRM): Validation studies must integrate QRM principles to identify and manage risks related to Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).

• Timeline: While large manufacturers have a shorter deadline, Small and Medium-sized Manufacturers (MSMEs) have a conditional extension to December 31, 2025, to comply with the Revised Schedule M. Validation documentation upgrades are the most time-consuming part of this compliance.

2. CDSCO North Zone: Export and Specialized Approvals

The CDSCO North Zone is involved in:

• Written Confirmation (WC) for APIs: For API manufacturers in Faridabad exporting to the European Union (EU), the WC is issued by the CDSCO. This certification requires assurance that the site complies with GMP standards equivalent to EU GMP/ICH Q7. Your validation documentation must explicitly meet these ICH Q7 principles.

• Joint Inspections: The CDSCO North Zone participates in joint inspections with the Haryana DCD for the grant/revalidation of certain licenses, especially for critical or export-oriented products.

3. Haryana DCD Licensing

The State DCD ensures that manufacturers have the necessary infrastructure and validated procedures before granting or renewing a Manufacturing License. This requires submission of:

• Manufacturing Process Details: Supported by full Process Validation data.

• Quality Control Methods: Supported by Analytical Method Validation (AMV) reports.

🎯 Compliance Focus: Who We Support

We work with manufacturers operating in the Faridabad industrial area:

• API Exporters: Requiring validation documentation aligned with ICH Q7 to support CDSCO Written Confirmation (WC) and international customer audits.

• MSMEs: Needing urgent Gap Analysis and documentation generation to meet the extended but mandatory Revised Schedule M compliance deadline.

• New License Applicants: Seeking to compile a comprehensive, joint-inspection-ready technical dossier for the Haryana DCD and CDSCO.

🛠️ Our Process Validation Services for Faridabad

We provide complete, scientifically sound, and documentation-intensive support tailored to the specific regulatory demands of the Faridabad-Haryana region.

ServiceFaridabad / Haryana DCD / CDSCO North Zone FocusRevised Schedule M PVDevelopment of Validation Master Plans (VMP), PPQ Protocols, and CPV Plans aligned with the revised Schedule M and the lifecycle validation approach.ICH Q7 PV for APIsSpecialized validation protocols for API synthesis and cleaning, ensuring compliance with ICH Q7 standards to support the Written Confirmation process.AMV & System ValidationPreparation of detailed Analytical Method Validation (AMV) reports (ICH Q2(R1)) and Utility Qualification (e.g., HVAC, Water System) reports to satisfy both state and central authorities.Audit ReadinessPre-audit and documentation review focused on the key inspection points for the Haryana DCD's Schedule M audit and CDSCO's export assessments.

🤝 Get Started on Your Faridabad Validation

Ensure your process validation documentation is robust, complies with the 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 Faridabad project, simply provide:

• Product: Active Pharmaceutical Ingredient (API) or Finished Formulation

• Target Status: Revised Schedule M Compliance / WC Application / License Renewal

• 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.