🇮🇳 ValiPro: Surat (Gujarat) FDCA & CDSCO Validation Services

Ensure Flawless Compliance with the Mandatory Revised Schedule M and Meet the High Scrutiny of the Gujarat FDCA and CDSCO Zonal Office for Export and Quality Assurance.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers operating in the Surat industrial belt (e.g., Sachin, Palsana, Hazira). Our documentation is built for full compliance with the rigorous standards of both the Gujarat Food and Drug Control Administration (FDCA) and the CDSCO Ahmedabad Zonal Office (which oversees Gujarat).

Key compliance pillars for Surat-based units include:

• State Control (Gujarat FDCA): The primary authority for licensing the manufacture and sale of drugs, 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 Ahmedabad Zonal Office): This office is responsible for central regulatory functions in Gujarat, including:

  • Processing applications for Certificate of Pharmaceutical Product (CoPP) for export.

  • Issuance of Written Confirmation (WC) for API export to the EU.

  • Coordination with the FDCA for joint specialized inspections.

• Export Focus: Surat's proximity to ports and its established industrial base mean many units are export-oriented (WHO-GMP, EU-GMP/ICH Q7).

• Revised Schedule M Mandate: Mandatory and time-bound adherence to the significantly upgraded Revised Schedule M, which aligns Indian GMP with international standards.

🌟 Why Validation is Crucial in Surat

Surat's manufacturers must satisfy both the stringent quality demands of the Gujarat FDCA and the international-level documentation required by the CDSCO for export certifications. The mandatory move to the Revised Schedule M makes validation a non-negotiable legal requirement.

1. Compliance with Revised Schedule M (The Validation Mandate)

The most critical regulatory focus is the shift to the Revised Schedule M, which became mandatory for MSMEs by December 31, 2025. The core of this compliance is the scientific documentation provided by validation.

• Validation and Qualification: The revised rules explicitly mandate the completion of Qualification (DQ, IQ, OQ, PQ) for all equipment and utilities and Validation of all critical manufacturing processes, cleaning procedures, and analytical methods.

• System-Based GMP: Auditors will now look for evidence of control and risk management (QRM), not just documentation. Process Validation Reports are the primary evidence that manufacturing risk is managed and quality is consistent.

• Facility Upgrade: The Revised Schedule M requires facility design (walls, floors, air handling, segregation) to meet modern standards. Validation of critical utilities (like HVAC and Water Systems) must follow the facility upgrade.

2. CDSCO Ahmedabad Zonal Office: Export & Certification

The validation documentation must be robust enough to support the central certifications required for global market access:

• CoPP Issuance (WHO-GMP): The Certificate of Pharmaceutical Product (CoPP) is required for export to many countries. Its issuance is contingent upon a satisfactory joint inspection (FDCA and CDSCO), which verifies that the site's manufacturing processes are validated and meet WHO-GMP standards.

• Written Confirmation (WC) for APIs: For API manufacturers exporting to the EU, the Written Confirmation process requires proof of compliance with ICH Q7 (API GMP). This is primarily demonstrated through rigorous Process Validation and Cleaning Validation reports.

3. Gujarat FDCA Licensing and Inspection

The local FDCA inspectors require validation data for:

• Manufacturing License Renewal: Submission of current and comprehensive technical dossiers, including validated manufacturing process details and quality control methods.

• Non-Compliance Resolution: Validation data is often necessary to provide Corrective and Preventive Actions (CAPA) in response to deficiency memos raised during local inspections.

🎯 Compliance Focus: Who We Support

We work with manufacturers operating in the Surat region:

• Export-Oriented Units (EOUs): Requiring validation documentation aligned with WHO-GMP/ICH Q7 to support CoPP/WC applications to the CDSCO Ahmedabad Zonal Office.

• MSMEs: Needing a comprehensive Gap Analysis and a strategic plan to complete all mandatory validation and qualification before the Revised Schedule M deadline.

• New Drug Manufacturers: Firms needing to compile full prospective Process Validation (PPQ) reports for new product launches.

🛠️ Our Process Validation Services for Surat

We provide complete, scientifically sound, and documentation-intensive support tailored to the high regulatory demands of the Gujarat FDCA and the CDSCO Zonal Office.

ServiceSurat / Gujarat FDCA / Revised Schedule M FocusSchedule M PV UpgradeDevelopment of Validation Master Plans (VMP), PPQ Protocols, and CPV Plans aligned with the latest Revised Schedule M (2023) and QRM principles.Export Certification PVStructuring validation summaries and data to support the CoPP (WHO-GMP) and WC (ICH Q7) applications to the CDSCO Zonal Office.Utility QualificationComplete Water System Validation (purified, WFI) and HVAC Qualification reports, critical for Schedule M compliance in a humid climate.Cleaning ValidationDesigning and reporting cleaning validation studies to prevent cross-contamination, essential for multi-product facilities in the Surat belt.

🤝 Get Started on Your Surat Validation

Ensure your process validation documentation is robust, complies with the mandatory Revised Schedule M, and meets the standards required by the local Gujarat FDCA and the CDSCO Zonal Office.

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

• Product: Dosage form (e.g., tablet, capsule, API) 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.

Contact ValiPro today to ensure your validation complies with the Surat FDCA and