🇮🇳 ValiPro: Pune (Maharashtra) FDA & CDSCO Validation Services

Ensure Flawless Compliance with the Revised Schedule M and Meet the Rigorous Technical Demands of the Maharashtra FDA and the CDSCO West Zone for Biologicals and Critical Products.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers operating in the Pune industrial belt (e.g., Pimpri-Chinchwad, Bhosari, Ranjangaon). Our documentation is built for full compliance with the rigorous standards of the Maharashtra Food and Drug Administration (FDA) Pune Division (state authority) and the CDSCO West Zone Office (central authority, based in Mumbai, with jurisdiction over the Pune Division).

Key compliance pillars for Pune-based units include:

• State Control (Maharashtra FDA, Pune): The immediate and 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 and Schedule M.

• Central Control (CDSCO West Zone): Responsible for the approval of New Drugs, Clinical Trials, and licensing of specified categories of critical drugs such as Vaccines, Sera, Blood Products, and IV Fluids. Given Pune's prominence (e.g., Serum Institute of India), the scrutiny in these areas is exceptionally high.

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

🌟 Why Validation is Crucial in Pune

Pune's manufacturing base requires validation that not only satisfies the routine checks of the State FDA but also meets the highly specialized and globally benchmarked standards of the CDSCO for biological and export-oriented products.

1. Compliance with Revised Schedule M (FDA Enforcement)

The Maharashtra FDA is rigorously enforcing the Revised Schedule M, which became mandatory for compliance for large units in June 2024. MSMEs (turnover $\le ₹250$ Crores) were conditionally extended until December 31, 2025, provided they submitted a plan for upgradation in Form A to the Central Licensing Authority.

• Validation of Processes: The revised rules explicitly require the auditor to look for evidence of a validated process and validated analytical methods. This necessitates a shift to Process Performance Qualification (PPQ) and Continued Process Verification (CPV).

• Qualification of Systems: All critical utilities (e.g., Water System, HVAC) and equipment must be formally Qualified (IQ, OQ, PQ) to meet the new standards before the December 2025 deadline.

2. CDSCO West Zone: Specialized Product & Export Focus

The CDSCO West Zone and its coordination with the Pune Division FDA require stringent validation for specific activities:

• Biological Products: For manufacturers of Vaccines, Sera, and r-DNA products (highly concentrated in Pune), the license is granted jointly with the CDSCO. This requires specialized validation, including:

  • Sterilization Cycle Validation

  • Aseptic Process Simulation (Media Fills)

  • Process Characterization and Viral Clearance Studies (for biologicals)

• Export Certification: To obtain Certificate of Pharmaceutical Product (CoPP) (WHO-GMP) or Written Confirmation (WC) (ICH Q7 for APIs), the validation documentation must meet internationally harmonized standards (ICH/WHO/PIC/S).

3. State FDA Licensing

The Pune Division FDA manages licensing, and the technical documentation submitted for license renewal and product approvals (including detailed manufacturing process flow and analytical methods) must be supported by scientifically sound Process Validation and Analytical Method Validation (AMV) reports.

🎯 Compliance Focus: Who We Support

We work with manufacturers operating in the Pune industrial regions:

• Biological/Vaccine/LVP Units: Requiring highly specialized validation protocols to meet the joint inspection requirements of the CDSCO West Zone for critical product licensing.

• MSMEs: Needing urgent Gap Analysis and documentation upgrade plans to meet the mandatory Revised Schedule M compliance deadline of December 31, 2025.

• Export-Oriented Units: Ensuring their PV and Cleaning Validation align with WHO-GMP/ICH Q7 to support CoPP/WC applications and international audits.

🛠️ Our Process Validation Services for Pune

We provide complete, scientifically sound, and documentation-intensive support tailored to the complex and high-quality demands of the Pune pharmaceutical hub.

ServicePune / Maharashtra FDA / 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.Specialized ValidationAseptic Process Simulation (Media Fill) and Sterilization Cycle Validation protocols for Injectable/Sterile product manufacturers.Biologics Validation SupportDocumentation for Process Characterization and Cleanliness Validation unique to biotech/vaccine manufacturing processes.AMV & Utility QualificationPreparation of detailed Analytical Method Validation (AMV) reports (ICH Q2(R1)) and Utility Qualification reports (Water System, HVAC).

🤝 Get Started on Your Pune Validation

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

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

• Product: Dosage form (e.g., Vaccine, Biologic, LVP, 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.