🇻🇳 ValiPro: DAV, ASEAN & PIC/S GMP Process Validation Services

Ensure Rapid Product Registration and Regulatory Approval with Vietnam's Drug Administration (DAV).

ValiPro provides expert Process Validation Protocol and Report services tailored for manufacturers targeting the highly regulated Vietnamese market. Our documentation is built for full compliance with the standards of the Drug Administration of Vietnam (DAV) under the Ministry of Health (MOH), specifically adhering to the ASEAN GMP Guidelines and the internationally recognized PIC/S GMP standard.

We specialize in supporting manufacturers of Pharmaceuticals (Modern and Traditional), APIs, and Health Supplements, ensuring their validation packages secure timely DAV approvals, minimize deficiency letters, and support the mandatory GMP assessment for foreign facilities.

🌟 Why DAV-Ready Validation is Crucial

Vietnam is a critical market in Southeast Asia, and its regulatory body (DAV) strictly enforces GMP standards, often aligning with regional and international benchmarks.

• ASEAN & PIC/S Alignment: Vietnam is actively harmonizing its regulations with ASEAN and is moving towards full adoption of PIC/S GMP. Your validation documents must meet these rigorous standards.

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

• Foreign Site Assessment: The DAV mandates that foreign manufacturing sites possess valid GMP certification from an authority recognized by Vietnam, or undergo a full assessment. Our high-standard, globally compliant validation reports are essential evidence for demonstrating a state of control.

🎯 DAV Compliance Focus: Who We Support

We work closely with manufacturers and their local registration agents in Vietnam who need:

• Pharmaceutical Exporters: Targeting registration for Modern and Traditional Drugs with the DAV.

• GMP Certification: Overseas facilities applying for the initial or renewal of the GMP Certificate recognized by the DAV (which is typically renewed every 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 or deficiency letters issued by DAV assessors regarding manufacturing process controls and capability.

🛠️ Our DAV Process Validation Services

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

ServiceDAV / ASEAN FocusPVP & PVR PreparationCustom protocols and reports aligned with the ACTD and ASEAN Guideline on Process Validation, emphasizing critical process parameters and robust control strategies.GMP Assessment DocumentationPreparation and compilation of the extensive validation documents required for GMP assessment of foreign sites (aligned with PIC/S principles).ACTD Quality Module SupportStructuring and presenting validation summaries and data specifically for ACTD's Part II (Quality), including demonstration of process capability and control.Gap Assessment (ASEAN/PIC/S)Reviewing your current validation procedures against the latest ASEAN GMP Guidelines and the PIC/S GMP Guide.Query HandlingProviding expert technical defense and drafting responses to address DAV assessor queries quickly and thoroughly.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards prioritized by the Drug Administration of Vietnam:

• ASEAN GMP Guidelines: The primary regional standard adopted by Vietnam for quality system and validation requirements.

• PIC/S GMP Guide: Increasingly used by the DAV as the benchmark for facility quality and control.

• 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 supports a modern, risk-based approach favored by the DAV.

🤝 Get Started on Your DAV Validation

Ensure your process validation documentation is robust and immediately acceptable to the DAV, securing both your GMP certification and your product registration in Vietnam.

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

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

• Target DAV Status: Product Registration / GMP Certification (New or Renewal)

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

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