🇮🇳 ValiPro: Vapi (GIDC) FDCA & CDSCO Validation Services
Ensure Flawless Compliance with the Mandatory Revised Schedule M and Meet the High Technical Demands of the Gujarat FDCA and CDSCO for API Export Certifications.
ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers operating in the Vapi GIDC estate. Our documentation is built for full compliance with the rigorous standards of the Gujarat Food and Drug Control Administration (FDCA) and the CDSCO Ahmedabad Zonal Office.
Key compliance pillars for Vapi-based units include:
State Control (Gujarat FDCA): The immediate authority for local inspections and licensing (API and formulation manufacturing). The FDCA ensures adherence to the Drugs and Cosmetics Act and the Revised Schedule M within the Valsad district.
Central Control (CDSCO Zonal Office): Critical for Vapi's predominantly export-oriented units. The CDSCO reviews and issues:
Written Confirmation (WC) for API export to the European Union (EU), which explicitly requires compliance with ICH Q7 (API GMP).
Certificate of Pharmaceutical Product (CoPP) for export to non-EU regulated markets.
Process Specificity (API Focus): Validation must address the complexities of chemical synthesis, including rigorous Cleaning Validation to manage high-risk cross-contamination in multi-product API plants.
Revised Schedule M Mandate: Mandatory and time-bound adherence to the significantly upgraded Revised Schedule M, which integrates WHO-GMP and international quality standards.
🌟 Why Validation is Crucial in Vapi
Vapi manufacturers, especially those involved in API and intermediates, are under intense regulatory pressure to document quality, particularly concerning the mandatory Schedule M upgrade and the high bar set for international export certifications.
1. Mandatory Compliance with Revised Schedule M (FDCA & CDSCO Enforcement)
The Revised Schedule M applies uniformly across India, and both the Gujarat FDCA and the CDSCO are initiating inspections to enforce it.
Validation of Processes: The Revised Schedule M mandates a scientifically sound approach to manufacturing. Manufacturers must provide evidence of a fully defined and validated process and validated analytical methods.
Qualification of Systems: Given the chemical focus in Vapi, validation of critical utilities, especially the Water System (if applicable) and the HVAC/Ventilation system for solvent handling, must be completed and documented (IQ, OQ, PQ).
Deadline: Small and Medium-sized Manufacturers (MSMEs) in Vapi have a conditional deadline of December 31, 2025, to achieve full compliance with the Revised Schedule M, provided they submitted their upgradation plan in Form A. Non-compliant units face immediate regulatory action.
2. CDSCO & ICH Q7 Compliance (Export Gateway)
Vapi is a major source for APIs exported globally. The documentation supporting export certifications must be flawless.
Written Confirmation (WC): Vapi manufacturers seeking to export APIs to the EU must obtain a WC from the CDSCO. This certification explicitly confirms that the manufacturing site's GMP is equivalent to EU standards (i.e., ICH Q7). This requires:
Rigorous Process Validation demonstrating batch consistency.
Cleaning Validation reports with scientifically justified limits and swab/rinse testing.
Comprehensive Qualification of equipment used in synthesis and purification.
International Audits: Vapi units are routinely audited by international bodies (US FDA, MHRA, EDQM). Validation reports form the backbone of the defensive dossier during these inspections.
3. Environmental Compliance Integration (GPCB & FDCA)
Beyond drug regulation, Vapi's unique environmental challenges (CETP compliance, hazardous waste) are often integrated into regulatory review. Validation reports for solvent recovery and utility systems must indirectly support compliance with both the FDCA and the Gujarat Pollution Control Board (GPCB).
🎯 Compliance Focus: Who We Support
We work with manufacturers operating in the Vapi GIDC and surrounding areas:
API/Intermediate Manufacturers: Requiring validation documentation aligned with ICH Q7 (API GMP) to support Written Confirmation (WC) applications and international customer audits.
MSMEs: Needing a strategic, high-priority plan to execute all mandatory Qualification and Validation to meet the Revised Schedule M compliance deadline.
Contract Manufacturers: Seeking robust validation packages for client-specific products and technology transfer protocols.
🛠️ Our Process Validation Services for Vapi
We provide complete, scientifically sound, and documentation-intensive support tailored to the high regulatory and technical demands of the Vapi API manufacturing hub.
ServiceVapi / Gujarat FDCA / CDSCO FocusRevised Schedule M PV UpgradeDevelopment of Validation Master Plans (VMP), PPQ Protocols, and CPV Plans aligned with the latest Revised Schedule M (2023) and QRM principles.ICH Q7 PV & CleaningSpecialized validation for API synthesis and rigorous Cleaning Validation reports with protocols targeting solvent and API carryover limits.Process Control StrategyDocumentation outlining CPPs, CQAs, and the control strategy, mandatory for both Revised Schedule M and advanced ICH Q guidelines.Utility QualificationComplete Water System Validation and HVAC Qualification reports for controlled manufacturing and clean rooms.
🤝 Get Started on Your Vapi Validation
Ensure your process validation documentation is robust, complies with the mandatory Revised Schedule M, and meets the global standards required by the CDSCO Zonal Office for API export.
To receive a Technical Scope and Commercial Proposal tailored for your Vapi project, simply provide:
Product: Active Pharmaceutical Ingredient (API) or Intermediate
Target Status: Revised Schedule M Compliance / Written Confirmation (WC) Application / International Audit Readiness
Manufacturing Process: Overview of critical synthesis steps and solvent usage
Timeline: Target audit date or submission date
Existing Data: Current validation master plan or any recent regulatory deficiency letters.