🇮🇳 ValiPro: Visakhapatnam (AP) Drugs Control & CDSCO Validation Services

Ensure Flawless Compliance with the Mandatory Revised Schedule M and Meet the High Scrutiny of the Andhra Pradesh Drugs Control Administration and the CDSCO Sub-Zonal/Port Office.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers operating in the Visakhapatnam region, particularly those in the JNPC. Our documentation is built for full compliance with the rigorous standards of both the Andhra Pradesh Drugs Control Administration (DCA) (state authority) and the CDSCO Sub-Zonal Office and Seaport Office (central authority) located in Vizag.

Key compliance pillars for Visakhapatnam-based units include:

• State Control (Andhra Pradesh DCA): The primary authority for licensing and local GMP inspections, ensuring compliance with the state's implementation of the Drugs and Cosmetics Act, 1940, and the mandatory Revised Schedule M.

• Central Control (CDSCO Sub-Zone/Port Office): Visakhapatnam hosts a dedicated CDSCO Sub-Zonal Office and a Seaport Office. These offices are critical for:

  • Regulating the Import/Export of drugs and ensuring quality at the port.

  • Coordinating with the State DCA for enforcing quality standards.

  • The Sub-Zonal Office reports to the CDSCO Hyderabad Zonal Office for major certifications like CoPP and Written Confirmation (WC).

• Export Focus (JNPC): The Jawaharlal Nehru Pharma City is a major hub for API, Bulk Drug, and formulation manufacturing, with significant international exports, requiring compliance with global standards like WHO-GMP/ICH Q7.

• Revised Schedule M Mandate: Mandatory and time-bound adherence to the significantly upgraded Revised Schedule M, which integrates international quality standards.

🌟 Why Validation is Crucial in Visakhapatnam

Vizag's dual role as a major manufacturing cluster (JNPC) and a port city means manufacturers face high scrutiny. Robust, documented validation is essential to manage product quality, satisfy both the State DCA and the CDSCO, and ensure smooth export operations.

1. Mandatory Compliance with Revised Schedule M

The Revised Schedule M requires a shift from passive documentation to a proactive System-Based GMP. This requires all processes to be scientifically proven and documented through validation.

• Process Validation (PV) Lifecycle: The revised rules mandate a lifecycle approach, requiring evidence of Process Design, Process Performance Qualification (PPQ), and ongoing Continued Process Verification (CPV) to prove process consistency.

• Qualification: All critical equipment and utilities—especially Water Systems and HVAC (critical in the coastal environment)—must be fully Qualified (IQ, OQ, PQ) to demonstrate suitability for use.

• Deadline: Small and Medium-sized Manufacturers (MSMEs) in Vizag have a conditional extension until December 31, 2025, to achieve full compliance with the Revised Schedule M. The State DCA and CDSCO have begun joint inspections, and non-compliance can lead to license suspension.

2. CDSCO Sub-Zone/Port Office: Export and Quality Gate

The local CDSCO offices ensure that drugs traded through Visakhapatnam meet central quality standards:

• Port Regulation: The CDSCO Seaport Office monitors the quality of drugs entering and exiting the port. Robust Process Validation and Analytical Method Validation (AMV) reports are indirect evidence of product quality, preventing regulatory issues during shipping.

• Export Certification (CoPP/WC): For manufacturers in JNPC exporting APIs to the EU, Written Confirmation (WC) is required. Validation reports must align with ICH Q7 (API GMP) standards. For other markets, CoPP (WHO-GMP) requires similar robust validation support.

3. Andhra Pradesh DCA Licensing

The State DCA uses validation reports to assess the capability of the facility for license renewal and new product approvals. The DCA has previously issued circulars emphasizing the need for vendor validation and due diligence, showing a high focus on systemic quality assurance that is directly supported by comprehensive validation.

🎯 Compliance Focus: Who We Support

We work with manufacturers operating in the Visakhapatnam region, including JNPC:

• API/Bulk Drug Manufacturers: Requiring validation documentation aligned with ICH Q7 to support Written Confirmation (WC) applications and international customer audits.

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

• Export-Oriented Units (EOUs): Requiring validation packages that satisfy both the local DCA and the international standards required by the CDSCO.

🛠️ Our Process Validation Services for Visakhapatnam

We provide complete, scientifically sound, and documentation-intensive support tailored to the specific export and quality demands of the Vizag pharmaceutical hub.

ServiceVisakhapatnam / AP DCA / Revised Schedule M FocusSchedule M PV UpgradeDevelopment of Validation Master Plans (VMP), PPQ Protocols, and CPV Plans aligned with the latest Revised Schedule M and QRM principles.ICH Q7 PV & CleaningSpecialized validation for API synthesis and rigorous Cleaning Validation reports to prevent cross-contamination in the multi-product JNPC environment.Utility QualificationComplete Water System Validation (purified, WFI) and HVAC Qualification reports, critical for Schedule M compliance and export audits in the tropical climate.AMV & AuditsPreparation of detailed Analytical Method Validation (AMV) reports (ICH Q2(R1)) to support QC compliance and regulatory submissions.

🤝 Get Started on Your Visakhapatnam Validation

Ensure your process validation documentation is robust, complies with the mandatory Revised Schedule M, and meets the standards required by the CDSCO Sub-Zonal/Port Office and the Andhra Pradesh DCA.

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

• Product: Active Pharmaceutical Ingredient (API) or Finished Formulation (e.g., tablet, liquid)

• 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.