🇨🇳 ValiPro: NMPA (China) GMP Validation Services
Ensure Validation Documentation Meets Chinese GMP (2010 Revision) and CDE/CFDI Requirements to Successfully Obtain Drug Marketing Authorization (MAA) in China.
ValiPro provides expert Process Validation services tailored to meet the strict GMP requirements enforced by the NMPA for foreign manufacturers supplying the Chinese market. The standards are aligned with global expectations and are under continuous evolution toward full PIC/S harmonization.
Key compliance pillars for market access in China include:
National Authority (NMPA/CDE/CFDI): The CDE reviews the Quality dossier, and the CFDI conducts the on-site Registration Inspection to verify the authenticity of the dossier and the commercial production conditions.
Manufacturing Standard (Chinese GMP 2010): All facilities must comply with the Good Manufacturing Practice for Drugs (2010 Revision), which includes detailed requirements for Qualification and Validation.
Validation Requirements: Mandatory adherence to the lifecycle approach to validation, explicitly requiring evidence of Process Validation, Qualification (DQ, IQ, OQ, PQ), and Analytical Method Validation (AMV).
Dossier Submission: Marketing Authorization Applications (MAA) must be submitted electronically in the eCTD format, with all quality and validation data contained within Module 3 (Quality/CMC).
🌟 Why Validation is Crucial for NMPA Compliance
Validation is a primary focus of the NMPA's inspection and review process. Failure to provide true, reliable, and complete validation data is a major cause for non-approval or rejection of a registration application.
1. Mandatory Qualification and Validation (Chinese GMP 2010)
The NMPA's GMP regulations explicitly mandate documented evidence for various validation and qualification activities:
Process Validation (Article 140): The NMPA requires formal Process Validation to verify that a manufacturing process, operated within established parameters, can consistently produce products that are suitable for their intended use and in accordance with the registration requirements. Thi12s includes verification of the commercial-scale production process.
Qualification: Article 140 requires documented evidence for all four stages of qualification: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Cleaning Validation: Required to prevent cross-contamination, especially in multi-product facilities.
2. Dossier Authenticity and On-Site Inspection (CFDI)
The NMPA's inspection process places high emphasis on data integrity and consistency between the dossier and the actual manufacturing site:
Registration Inspection: This inspection is initiated by the CDE to verify the authenticity and consistency of the drug registration application dossiers. The CFDI inspects the CMC development activities, including the original data, records of pharmaceutical formulation, process study, and trial sample manufacturing.
Manufacturing Site Inspection (Dynamic Production): The CFDI will verify the commercial-scale production process validation batches and may require an on-site inspection during dynamic manufacturing on the planned commercial production line, organized in accordance with GMP.
Analytical Method Validation (AMV): The dossier must include validation data for test methods, including specific tests like sterility and microbial limits in accordance with the current Chinese Pharmacopoeia (ChP). The CFDI will inspect the original data records for the Quality Control (QC) study.
3. International Harmonization (ICH & PIC/S)
Although formal Chinese GMP (2010) is the basis, the NMPA is rapidly adopting international guidelines:
Aseptic Processes (Sterile Annex): The NMPA is actively working to harmonize its Sterile Annex with the revised EU GMP Annex 1, which requires a Contamination Control Strategy (CCS) and a strong lifecycle approach to aseptic processing validation. Foreign manufacturers must meet this evolving, stricter standard.
Risk Management: China is studying and implementing the principles of ICH Q9 (Quality Risk Management), meaning validation efforts must be scientifically justified and documented based on risk.
🎯 Compliance Focus: Who We Support
We work with foreign manufacturers targeting the Chinese market:
First-Time NMPA Applicants: Assisting in structuring the validation summaries and data for the eCTD Module 3 to meet the specific requirements of the CDE for technical review.
Manufacturers Awaiting CFDI Inspection: Preparing the site's Validation Master Plan (VMP), execution protocols, and ensuring the readiness of original data records for the rigorous Registration Inspection.
Aseptic/Sterile Manufacturers: Specializing in validation that meets the NMPA's high expectations for sterile drug production, aligning with the new global standards (EU GMP Annex 1).
🛠️ Our Process Validation Services for NMPA Compliance
We provide complete, scientifically sound, and NMPA-compliant validation documentation ready for CDE submission and CFDI audit defense.
ServiceNMPA / Chinese GMP / ICH FocusNMPA VMP & PVDevelopment of a Validation Master Plan (VMP) and Process Performance Qualification (PPQ) protocols aligned with the Chinese GMP (2010).Analytical Method Validation (AMV)Execution and reporting of Method Validation studies (ICH Q2 principles) and specific compliance with the Chinese Pharmacopoeia (ChP) requirements.Aseptic Validation & CCSSpecialized validation for sterile manufacturers, including Aseptic Process Simulation (Media Fills), with documentation supporting a Contamination Control Strategy (CCS).Data Integrity Audit SupportReview and remediation of validation records and electronic system data to ensure authenticity, accuracy, and traceability for CFDI inspection.
🤝 Next Step: Secure NMPA Validation Readiness
Ensure your validation documentation is robust, traceable, and fully aligned with the stringent requirements of the NMPA's CDE and CFDI to successfully navigate the drug registration and inspection process in China.
To receive a Technical Scope and Commercial Proposal tailored for your China project, simply provide:
Product: Active Pharmaceutical Ingredient (API) or Finished Formulation (e.g., sterile injectable, tablet)
Application Type: New Drug Application (NDA) / Generic Drug Registration
Manufacturing Process: Overview of critical steps and control strategy
Timeline: Target submission date for the NMPA CDE