🇮🇳 ValiPro: Mumbai (West Zone) CDSCO & Maharashtra FDA Validation Services

Ensure Flawless Compliance with the Revised Schedule M and Meet the High Technical Demands of the CDSCO West Zone for Critical Product Licensing and International Certifications.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers operating in the Mumbai region and the state of Maharashtra. Our documentation is built for full compliance with the rigorous standards of both the Maharashtra Food and Drug Administration (FDA) (state authority) and the CDSCO West Zone Office (central authority).

Key compliance pillars for Mumbai-based units include:

• Central Control (CDSCO West Zone): Located in Mumbai Central, this is the nodal authority for Maharashtra, Goa, Chhattisgarh, and UTs. Its crucial functions include:

  • Issuance/Revalidation of Certificate of Pharmaceutical Products (CoPPs) as per the WHO Certification Scheme.

  • Processing applications for Written Confirmation (WC) for API export to the European Union (EU).

  • Joint Inspection for specialized manufacturing licenses: Vaccines, Sera, Large Volume Parenterals (LVP), and Medical Devices (Class C & D).

• State Control (Maharashtra FDA): The principal state regulatory authority for granting/renewing manufacturing and sales licenses and enforcing local GMP (Schedule M) compliance across the state. The Mumbai FDA Laboratory is NABL accredited with high testing capacity.

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

🌟 Why Validation is Crucial in the Mumbai Hub

Mumbai-based units, especially those dealing with exports and critical products (LVP, Vaccines), face the highest level of regulatory scrutiny from the CDSCO West Zone. Robust, documented validation is mandatory for all key central certifications and state license retention.

1. CDSCO West Zone: Critical Functions & Validation Link

The CDSCO West Zone performs several functions where validation reports are the core evidence of compliance:

CDSCO West Zone FunctionValidation Requirement LinkCoPP Issuance (WHO-GMP)The Maharashtra FDA Joint Commissioner (HQ) processes the application, but a Joint Inspection with CDSCO West Zone is required. Full Process, Cleaning, and Utility Validation reports aligned with WHO-GMP are mandatory.Written Confirmation (WC) for APIsNecessary for export to the EU. Validation documentation must demonstrably comply with ICH Q7 (API GMP) principles to support the WC application.Specialized LicensingFor Vaccines, Sera, and LVP manufacturing licenses, the CDSCO West Zone participates in joint inspections. This requires specialized validation such as Aseptic Process Simulation (Media Fills) and Sterilization Cycle Validation.Medical DevicesCDSCO West Zone grants licenses for Class C & D medical devices. Validation must align with Medical Device Rules, 2017 (e.g., process validation for sterilization, software validation).

2. Compliance with Revised Schedule M (FDA Enforcement)

The Maharashtra FDA is rigorously enforcing the Revised Schedule M, which became mandatory for compliance by the end of 2024 for large units and by December 31, 2025, for MSMEs.

The revised schedule makes validation explicit and central to GMP:

• Qualification and Validation: Explicitly mandates Qualification (IQ, OQ, PQ) of equipment and utilities (HVAC, Water System). Process Validation is required to prove that the manufacturing process is robust and consistently produces a quality product.

• Quality System Integration: Requires the use of Quality Risk Management (QRM) to identify CQAs and CPPs, which form the basis of all validation protocols.

• Data Integrity (ALCOA+): Validation documentation must ensure ALCOA+ principles are followed, including the use of validated computerized storage systems (CSV) for all quality records.

🎯 Compliance Focus: Who We Support

We work with manufacturers operating in the Mumbai and Maharashtra region:

• Exporters (FPP & API): Requiring validation documentation aligned with WHO-GMP/ICH Q7 to support CoPP and Written Confirmation (WC) applications to the CDSCO West Zone.

• Specialized Product Units: Firms manufacturing LVPs, Vaccines, or high-risk Medical Devices that require CDSCO joint inspections.

• MSMEs: Needing urgent Gap Analysis and documentation upgrade plans to meet the mandatory Revised Schedule M compliance deadline enforced by the Maharashtra FDA.

🛠️ Our Process Validation Services for Mumbai

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

ServiceMumbai / CDSCO West Zone / 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.Specialized ValidationAseptic Process Simulation (Media Fill) and Sterilization Cycle Validation protocols and reports for Injectables and LVPs.AMV & Utility QualificationPreparation of detailed Analytical Method Validation (AMV) reports (ICH Q2(R1)) and Utility Qualification reports (Water System, HVAC) essential for DCD/CDSCO audits.Export Certification SupportStructuring validation summaries and data to support the CoPP (WHO-GMP) and WC (ICH Q7) applications to the CDSCO West Zone.

🤝 Get Started on Your Mumbai Validation

Ensure your process validation documentation is robust, meets the stringent requirements of the CDSCO West Zone for specialized licensing and exports, and complies fully with the Revised Schedule M enforced by the Maharashtra FDA.

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

• Product: Dosage form (e.g., LVP, Vaccine, API) and Batch Size

• Target Status: Revised Schedule M Compliance / CoPP Application / New Specialized License

• 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