🇹🇭 ValiPro: Thai FDA & PIC/S GMP Process Validation Services

🇹🇭 ValiPro: Thai FDA & PIC/S GMP Process Validation Services

Streamline Thai FDA Registration and Secure GMP Clearance for the ASEAN Market.

ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting Thailand, a key member of the ASEAN economic bloc. Our documentation is built for full compliance with the rigorous standards of the Thai Food and Drug Administration (Thai FDA), specifically adhering to PIC/S GMP guidelines and the ASEAN Common Technical Dossier (ACTD) format.

We specialize in supporting manufacturers of Modern Drugs, Traditional Medicines, API, and Medical Devices, ensuring their validation packages secure timely Thai FDA approvals, minimize deficiency letters, and support the mandatory GMP Clearance process for overseas facilities.

🌟 Why Thai FDA Validation Expertise is Essential

The Thai FDA, under the Ministry of Public Health, is a respected regulatory body in ASEAN. Meeting their standards is crucial for market entry.

• Mandatory GMP Clearance: Foreign manufacturers must obtain a GMP Certificate (or GMP Clearance) from the Thai FDA. This is a prerequisite for product registration, and our validation documentation is central to demonstrating your facility's adherence to PIC/S GMP.

• ACTD Submission Format: Drug registration dossiers must follow the ASEAN Common Technical Dossier (ACTD) structure. We ensure your process validation reports are correctly placed in Part II (Quality Document), meeting the regional format requirements.

• Streamlined Review Pathways: Thai FDA offers expedited/abridged reviews for drugs approved by reference agencies (US, EU, Japan, Australia). Our high-tier, ICH-compliant validation reports facilitate your eligibility for these faster pathways.

🎯 Thai FDA Compliance Focus: Who We Support

We work closely with foreign manufacturers and their local Marketing Authorization Holders (MAH) in Thailand who need:

• Pharmaceutical Exporters: Targeting registration for Modern Drugs (New Drugs and Generics) and Traditional Medicines.

• GMP Accreditation: Overseas facilities applying for initial or renewal of the Thai FDA GMP Clearance Certificate (which is typically valid for three years).

• ACTD Quality Module: Preparation of the Quality Control and Manufacturing Details section of the ACTD, including full Process Validation data.

• Regulatory Responses: Firms addressing technical queries issued by the Thai FDA Medicines Regulation Division, particularly those related to manufacturing process controls.

🛠️ Our Thai FDA Process Validation Services

Our services ensure your documentation is technically sound and precisely structured for Thai FDA submission efficiency.

ServiceThai FDA FocusPVP & PVR PreparationCustom protocols and reports aligned with the ACTD and ASEAN Guideline on Process Validation (typically requiring data from three consecutive production batches).GMP Clearance DocumentationPreparation and compilation of the extensive validation documents required for PIC/S GMP accreditation of foreign sites (fewer documents needed for PIC/S members).ACTD Quality Module SupportStructuring and presenting validation summaries and data specifically for ACTD's Part II (Quality) to avoid screening deficiencies.Gap Assessment (PIC/S)Reviewing your current validation documents against the latest PIC/S GMP Guide adopted by the Thai FDA.Query HandlingProviding expert technical defense and drafting responses to address Thai FDA assessor queries.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards prioritized by the Thai FDA and the ASEAN harmonization framework:

• PIC/S GMP Guide: The mandatory standard for both local and overseas manufacturing facilities seeking GMP clearance in Thailand.

• ASEAN Common Technical Dossier (ACTD): The required structure for the product registration application (Part II Quality, 3.2.P.3.4 Process Validation).

• ICH Q8, Q9, Q10: Alignment with these international lifecycle management principles, which supports the quality philosophy of the Thai FDA.

• ASEAN Guideline on Process Validation: Direct compliance with the specific validation requirements adopted by the ASEAN framework.

🤝 Get Started on Your Thai FDA Validation

Ensure your process validation documentation is robust and immediately acceptable to the Thai FDA, securing both your GMP Clearance and your product registration.

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

• Product: Dosage form (e.g., solid oral, injectable, API) and Batch Size

• Target FDA Status: GMP Clearance / Product Registration (New or Renewal)

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

• Existing Data: Any current validation documents or Thai FDA deficiency letters.