🇱🇻 ValiPro: ZVA (Latvia) EU GMP Validation Services

Ensure Flawless Validation Documentation (CTD Module 3) for ZVA Registration and Pass Mandatory GMP Audits by Adhering to PIC/S GMP and ICH Guidelines.

ValiPro provides expert Process Validation services specifically tailored to meet the strict EU GMP requirements enforced by the ZVA for both local Latvian manufacturers and foreign sites supplying the market.

Key compliance pillars for market access in Latvia include:

• National Authority (ZVA): The State Agency of Medicines of Latvia is responsible for registering medicines, authorizing safety features, and enforcing compliance with the Medicines and Related Substances Law, which incorporates all EU directives.

• Manufacturing Standard (EU GMP/PIC/S): All manufacturing, importation, and testing activities must comply with the EU Guidelines to Good Manufacturing Practice.

• Validation Requirements: Strict adherence to EU GMP Annex 15 (Qualification and Validation) is the cornerstone for all validation activities in Latvia.

• Dossier Submission: All applications for Marketing Authorization (MAA) must be submitted in the Common Technical Document (CTD) format, with all validation data contained within Module 3 (Quality/CMC).

🌟 Why Validation is Crucial for ZVA Compliance

The ZVA's review process and inspection activities rely entirely on documented validation to ensure the manufacturing process is robust and the product is consistently safe and effective.

1. Mandatory Qualification and Validation (EU GMP Annex 15)

The ZVA inspectors strictly check for full adherence to the principles laid out in EU GMP Annex 15 (Qualification and Validation), which mandates a scientifically justified, lifecycle approach to quality assurance:

• Qualification Lifecycle: All critical equipment and utilities must be fully Qualified through the four stages: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

• Process Validation Lifecycle: Critical manufacturing processes must be validated using a lifecycle approach: Process Design, Process Performance Qualification (PPQ), and Continued Process Verification (CPV).

• Quality Risk Management (QRM): The scope and extent of all validation activities (facilities, equipment, utilities, processes) must be based on a documented risk assessment, adhering to ICH Q9 principles.

2. Marketing Authorization Submission (CTD Module 3)

The Quality Module (Module 3) of the CTD dossier submitted to the ZVA must contain validation data that is technically rigorous to satisfy the assessors:

• Analytical Method Validation (AMV): All analytical testing methods (for finished product release and stability) must be validated according to ICH Q2(R1) to ensure reliable QC results.

• API Validation: Active Pharmaceutical Ingredient (API) production must be validated according to ICH Q7 (API GMP) principles, including process and cleaning validation.

• Change Control Validation: Any planned change to equipment, facilities, utilities, or processes that may affect product quality must be formally documented and the impact on the validated status must be assessed and, if necessary, revalidated.

3. ZVA GMP Audits

The ZVA conducts routine GMP inspections of domestic manufacturing sites and cooperates with other EU authorities for foreign site inspections.

• Audit Focus: Inspections focus on the Pharmaceutical Quality System (PQS) and verifying that the manufacturer's Validation Master Plan (VMP), protocols, and reports are executed and maintained to PIC/S standards.

• Falsified Medicines Directive (FMD): The Latvian medicines verification system (LZVO) is supervised by Latvian competent authorities. While not directly a manufacturing validation issue, the Computer System Validation (CSV) of the serialization systems must be compliant to ensure proper verification and decommissioning of unique identifiers from the national database.

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the Latvian market:

• Foreign Manufacturers (Importers): Requiring validation dossiers that meet the stringent ZVA/EU GMP requirements for the Marketing Authorization Application (MAA).

• Local Latvian Manufacturers: Needing comprehensive VMPs and execution of Qualification/Validation protocols to pass routine ZVA GMP inspections.

• Generic Drug Applicants: Providing robust Analytical Method Validation and Process Validation data to support the quality claims in the generic registration dossier.

🛠️ Our Process Validation Services for ZVA Compliance

We provide complete, scientifically sound, and EU-compliant validation documentation ready for ZVA submission and audit defense.

ServiceZVA / EU GMP / PIC/S FocusPIC/S VMP & PVDevelopment of a Validation Master Plan (VMP) and Process Performance Qualification (PPQ) protocols aligned with EU GMP Annex 15.Aseptic Processing ValidationSpecialized validation for sterile manufacturers, including Aseptic Process Simulation (Media Fills), aligning with the new EU GMP Annex 1.ICH Q7 API ValidationSpecialized validation for API manufacturers, including strict Cleaning Validation and Change Control Validation documentation.CTD Module 3 Technical SupportStructuring and organizing validation summaries and data for inclusion in the eCTD Module 3 to pass the ZVA's scientific assessment.

🤝 Next Step: Secure ZVA Validation Readiness

Ensure your validation documentation is robust, aligns with the mandatory EU GMP and ICH guidelines, and is ready to support your Latvian registration and GMP license application.

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

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

• Application Type: National MAA / Decentralized Procedure (DCP) / Mutual Recognition Procedure (MRP)

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Target submission date for ZVA