🇮🇳 ValiPro: Kolkata (East Zone) CDSCO & West Bengal DCD Validation Services

Ensure Flawless Compliance with the Revised Schedule M and Meet the High Technical Demands of the CDSCO East Zone for Import/Export Documentation and Quality Control.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers operating in Kolkata and the wider West Bengal region. Our documentation is built for full compliance with the rigorous standards of both the West Bengal DCD (state authority) and the CDSCO East Zone Office (central authority).

Key compliance pillars for Kolkata-based units include:

• Central Control (CDSCO East Zone): Located in Kolkata, this is the nodal authority for the entire Eastern region. Its critical functions include:

  • Analytical Quality Control for imported drugs entering through Eastern ports and domestic products on behalf of Central/State agencies.

  • Coordination with State DCDs for uniform enforcement of the Drugs and Cosmetics Act.

  • Handling of Import/Export Bills and ensuring compliance for shipments through Kolkata's Seaport and Airport.

• State Control (West Bengal DCD): The state-level authority responsible for licensing the manufacture and sale of drugs, enforcing routine inspections, and ensuring compliance with Schedule M locally.

• Revised Schedule M: Mandatory adherence to the significantly upgraded Revised Schedule M of the Drugs & Cosmetics Act, which enforces WHO-GMP/PIC/S standards, pushing all manufacturers to upgrade their validation systems.

🌟 Why Validation is Crucial in Kolkata

Kolkata's position as a major port and regional CDSCO hub means validation documentation must meet stringent criteria to satisfy local manufacturing compliance and facilitate international trade, especially under the new Revised Schedule M regime.

1. Compliance with Revised Schedule M (System-Based GMP)

The Revised Schedule M mandates a shift from document-based GMP to a System-Based GMP. This requires manufacturers to demonstrate scientific control over their processes, which is achieved only through robust validation.

• Validation Requirements: The revised standards mandate:

  • Validated Process: Scientific proof that the manufacturing process consistently yields a product of desired quality.

  • Qualified Utilities and Equipment: Detailed Qualification (IQ, OQ, PQ) for critical systems like HVAC, Water, and production machinery.

  • Data Integrity: Validation of computerized systems and records to adhere to ALCOA+ principles.

• Deadline: Small and Medium-sized Manufacturers (MSMEs) in West Bengal have a conditional extension to December 31, 2025, to upgrade their systems to the Revised Schedule M. Validation documentation is the core component of this upgrade plan.

2. CDSCO East Zone: Quality Control and Export Focus

The local CDSCO office's focus on quality control and import/export makes validation documentation critical:

• Analytical Quality Control: The Central Drug Testing Laboratories (CDTL) analyze samples on behalf of the CDSCO East Zone. Your Analytical Method Validation (AMV) reports must be flawless to ensure method reliability and prevent regulatory issues stemming from sample failure.

• Export Checks (Port Office): For manufacturers exporting through Kolkata's port, the CDSCO Port Office checks shipping bills for compliance. Robust validation supports the integrity of the product and aids the smooth clearance of consignments.

• WHO-GMP/CoPP: The validation documentation must meet WHO-GMP standards to support the issuance of the Certificate of Pharmaceutical Product (CoPP) required for exports.

🎯 Compliance Focus: Who We Support

We work with manufacturers operating in the Kolkata and West Bengal regions:

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

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

• Traditional/Ayurvedic Pharma: Companies needing to formalize their manufacturing processes under Schedule M's new, stricter requirements for validation and qualification.

• Import/Export Firms: Requiring quality assurance documentation to facilitate smooth trade through Kolkata's ports under CDSCO scrutiny.

🛠️ Our Process Validation Services for Kolkata

We provide complete, scientifically sound, and documentation-intensive support tailored to the dual regulatory demands of the West Bengal DCD and the CDSCO East Zone.

ServiceKolkata / CDSCO East Zone / 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 and lifecycle management.AMV & Finished Product TestingPreparation of detailed Analytical Method Validation (AMV) reports (ICH Q2(R1)) to support the DCD's license approval and CDSCO's quality control checks.Utility QualificationHVAC, Water System, and Compressed Air Qualification (IQ/OQ/PQ) reports, mandatory for Schedule M compliance and critical for central audit readiness.CoPP/Export DocumentationStructuring validation data to meet WHO-GMP standards and support the quality claims on the Certificate of Pharmaceutical Product (CoPP) for international markets.

🤝 Get Started on Your Kolkata Validation

Ensure your process validation documentation is robust, meets the stringent requirements of the CDSCO East Zone for exports and quality control, and complies fully with the Revised Schedule M enforced by the West Bengal DCD.

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

• Product: Dosage form (e.g., tablet, injectable, Ayurvedic formulation) and Batch Size

• 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

• Existing Data: Current validation master plan or any recent regulatory deficiency letters.