🇱🇹 ValiPro: SMCA (Lithuania) EU GMP Validation Services

Ensure Flawless Validation Documentation (eCTD Module 3) for SMCA 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 SMCA for both local Lithuanian manufacturers and foreign sites supplying the market.

Key compliance pillars for market access in Lithuania include:

• National Authority (SMCA): The Lithuanian body responsible for evaluating and supervising medicines, granting Marketing Authorizations (MAA), and supervising manufacturing authorization holders (inspections and licensing).

• 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 definitive standard for all validation activities in Lithuania.

• Dossier Submission: All applications for MAA, renewals, and variations (under national, decentralized, or mutual recognition procedures) must be submitted electronically as e-dossier (eCTD or NeeS) via CESP (Common European Submission Portal). Validation data is included in Module 3 (Quality/CMC).

🌟 Why Validation is Crucial for SMCA Compliance

The SMCA conducts detailed scientific assessments during registration and routine GMP inspections. Both activities rely entirely on documented validation to prove the manufacturing process consistently yields a high-quality product.

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

SMCA auditors use the principles laid out in EU GMP Annex 15 as the primary guidance for assessing a manufacturer's validation status. This mandates a lifecycle, risk-based approach to validation:

• Qualification Lifecycle: All critical equipment and utilities (Water Systems, HVAC, computerized systems) 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 the modern, three-stage lifecycle approach: Process Design, Process Performance Qualification (PPQ), and Continued Process Verification (CPV).

• Quality Risk Management (QRM): Decisions on the scope and extent of all validation activities must be based on a documented risk assessment, adhering to ICH Q9 principles. Retrospective validation is no longer considered acceptable.

2. Marketing Authorization Submission (eCTD Module 3)

The eCTD dossier submitted to the SMCA must contain technically robust validation data 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).

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

• Electronic Submission: Lithuania mandates electronic submission (eCTD/NeeS via CESP). The format and completeness of the validation data within Module 3 must meet these technical requirements.

3. SMCA GMP Audits

The SMCA conducts routine GMP inspections of domestic manufacturing and wholesale sites and participates in the EU system for foreign site inspections.

• Audit Focus: Inspections focus on the entire 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.

• Compliance Verification: The SMCA is the national body responsible for verifying compliance with EU GMP for granting or renewing manufacturing and import licenses.

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the Lithuanian market:

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

• Local Lithuanian Manufacturers: Needing comprehensive VMPs and execution of Qualification/Validation protocols to pass routine SMCA 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 SMCA Compliance

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

ServiceSMCA / 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.eCTD Module 3 Technical SupportStructuring and organizing validation summaries and data for inclusion in the eCTD Module 3 to pass the SMCA's scientific assessment.

🤝 Next Step: Secure SMCA Validation Readiness

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

To receive a Technical Scope and Commercial Proposal tailored for your Lithuania 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 SMCA