🇱🇦 ValiPro: FDD (Laos) WHO-GMP Validation Services

Assist Foreign Manufacturers in Preparing Necessary GMP and Validation Documentation to Obtain Product Registration and Import Licenses from the FDD.

ValiPro supports pharmaceutical companies seeking to supply the Lao market by ensuring their manufacturing sites and quality documentation meet the required international standards, primarily those set by the World Health Organization (WHO) Good Manufacturing Practice (GMP) and the principles of the ASEAN Common Technical Dossier (ACTD).

Key compliance pillars for market access in Laos include:

• National Authority (FDD/MoH): The FDD is responsible for drug registration, manufacturer licensure, and inspection, often relying on the National Center of Food and Drug Analysis (NCFDA) for quality testing.

• Manufacturing Standard (WHO-GMP): Manufacturing of medicines in Laos is regulated by the Law on Drugs and Medical Products and related regulations, which are based on WHO-delineated Good Manufacturing Practice. Compliance is mandatory for both domestic and foreign suppliers.

• Dossier Format (ACTD): Product registration applications follow the ASEAN Common Technical Dossier (ACTD) format.

• Registration Process: The drug registration process is typically a two-step procedure, involving the submission of documentation for sample importation/manufacture (Form 1) followed by the submission for full product registration approval (Form 2, in ACTD format).

🌟 Why Validation is Crucial for FDD Compliance

Validation documentation is a mandatory part of the Quality dossier required for product registration. It is also the basis for securing and maintaining GMP certification, which is inspected by the FDD's Bureau of Food and Drug Inspection (BFDI).

1. Proof of Good Manufacturing Practice (WHO-GMP)

The FDD's requirements for factory establishment and certification are based on WHO-GMP principles, which demand documented evidence of process control:

• GMP Certification: Foreign manufacturers must submit proof of GMP compliance, typically a certificate from their country of origin that is aligned with WHO or other recognized international standards (e.g., PIC/S, EU GMP).

• GMP Audits: The FDD's GMP Committee performs document assessment and field visits for certification. The validity of the GMP certification is often 2 years. The audit specifically covers documentation, facilities, equipment, and production processes.

2. ACTD Quality Submission (Part II)

While the FDD may accept a subset of documents initially, the full application (Form 2) requires an ACTD-compliant dossier, where validation data is critical:

• ACTD Part II Requirements: The Quality Part of the ACTD requires a detailed description of the manufacturing process and evidence of controls. This includes summaries of Process Validation studies to demonstrate that the manufacturing process is robust and consistently produces a product meeting its pre-defined specifications.

• Analytical Method Validation (AMV): The application requires details on the Method of Analysis and reliability of the method of analysis certification. This means all analytical testing methods used for quality control must be validated according to globally accepted standards, such as those laid out in ICH Q2(R1).

3. FDD Laboratory Testing

The registration procedure requires sending samples to the National Center of Food and Drug Analysis (NCFDA) for independent quality analysis.

• Consistency Check: The NCFDA performs tests to ensure the medicine's quality aligns with the specifications detailed in the submitted dossier. The reliability of these specifications is directly dependent on a validated manufacturing process.

🎯 Compliance Focus: Who We Support

We work with foreign manufacturers targeting the Lao market:

• ASEAN Region Manufacturers: Assisting companies to align their validation documentation with the unified ACTD and ASEAN GMP requirements to streamline registration in Laos.

• Generic Drug Manufacturers: Ensuring that all Process Validation (PPQ) and Analytical Method Validation (AMV) data is robust, verifiable, and suitable for the FDD's scientific review and laboratory testing.

• Foreign Exporters: Providing the necessary technical validation summaries and GMP documentation required to obtain the company's registration certificate and subsequent import permissions.

🛠️ Our Process Validation Services for FDD Compliance

We provide robust, internationally accepted (WHO-GMP compliant) validation documentation ready for FDD submission and audit defense.

ServiceFDD / WHO-GMP / ACTD FocusWHO-GMP VMP & PVDevelopment of a Validation Master Plan (VMP) and Process Validation documentation aligned with WHO guidelines to support GMP certification.Analytical Method Validation (AMV)Execution and reporting of Method Validation studies (ICH Q2 principles) for all QC tests.ACTD Quality Module PreparationStructuring and writing the validation summaries for inclusion in the Quality Module (Part II) of the ACTD dossier.Qualification & Cleaning ValidationDocumentation to support the Qualification (IQ/OQ/PQ) of critical equipment and Cleaning Validation protocols to ensure compliance with GMP facility standards.

🤝 Next Step: Secure FDD Product Registration

Ensure your manufacturing site's GMP and validation status is clearly documented and summarized to support your product registration and importation efforts in Laos.

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

• Product: Active Pharmaceutical Ingredient (API) or Finished Formulation

• Dossier Format: ACTD / CTD (if available)

• Current GMP Certification: (e.g., WHO-GMP, EU GMP, PIC/S)

• Timeline: Target submission date for the FDD