🇺🇸 ValiPro: FDA, cGMP & Lifecycle Process Validation Services for the U.S. Market

Achieve US FDA Approval by Implementing the Lifecycle Process Validation Approach and Ensuring Complete Compliance with 21 CFR Part 211 (cGMP) and ICH Quality Guidelines.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers targeting the U.S. market. Our documentation is built for full compliance with the rigorous standards enforced by the FDA.

Key compliance pillars include:

• Lifecycle Process Validation: Mandatory adherence to the three-stage lifecycle model for process validation as outlined in the 2011 FDA Guidance on Process Validation.

• Current Good Manufacturing Practice (cGMP): Compliance with 21 CFR Parts 210 and 211 (including Part 11 for electronic records).

• eCTD Submission: Registration dossiers (NDA/ANDA/BLA) must be submitted electronically in the eCTD (Electronic Common Technical Document) format, with validation data in Module 3 (Quality).

• ICH Quality System: Integration of ICH Q8 (Pharmaceutical Development), Q9 (Quality Risk Management), and Q10 (Pharmaceutical Quality System) principles.

🌟 Why FDA Validation is Crucial

The FDA's philosophy is that quality cannot be tested into products; it must be built in by design. Process validation is the scientific documentation that proves the process consistently delivers quality.

1. The Three-Stage Process Validation Lifecycle

The FDA’s 2011 guidance mandates a lifecycle approach to validation, which moves beyond the traditional one-time event. Process validation documentation must cover all three stages:

StageFocusValiPro Service LinkStage 1: Process DesignBuilding and capturing process knowledge; identifying Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs); establishing a control strategy (ICH Q8, Q9).Quality by Design (QbD) DocumentationStage 2: Process Qualification (PPQ)Confirming the process design and demonstrating that the commercial manufacturing process is capable of consistently producing quality product. Typically involves three consecutive successful batches.PPQ Protocol and Report (21 CFR Compliant)Stage 3: Continued Process Verification (CPV)Ongoing assurance during routine production that the process remains in a state of control (ICH Q10). Requires continuous monitoring and statistical process control.CPV Plan and Trending Reports

2. cGMP and Application Requirements

• NDA/ANDA/BLA Submission: The New Drug Application (NDA), Abbreviated New Drug Application (ANDA) for generics, or Biologics License Application (BLA) must include comprehensive Chemistry, Manufacturing, and Controls (CMC) data. Process Validation reports and summaries are the backbone of the CMC section within the eCTD Module 3.

• Pre-Approval Inspection (PAI): Before final approval, the FDA conducts a PAI of the manufacturing facility. Inspectors verify that the firm's quality systems, including the execution and documentation of the Process Validation (Stage 2) and Cleaning Validation, are compliant with 21 CFR Part 211.

• Data Integrity (21 CFR Part 11): All electronic records and submissions (including eCTD) must comply with 21 CFR Part 11, requiring data integrity standards such as audit trails, access controls, and electronic signatures.

🎯 Compliance Focus: Who We Support

We work with international and domestic manufacturers targeting the U.S. market:

• New Drug Applicants (NDA): Preparing robust Stage 1 (Process Design) and Stage 2 (PPQ) data to support original applications.

• Generic Applicants (ANDA): Demonstrating biobatch linkage and providing Process Validation and Analytical Method Validation (AMV) data for the ANDA submission.

• Biologics Manufacturers (BLA): Providing in-depth Process Characterization and Validation for complex biological products.

• Foreign Establishments: Ensuring the complete Establishment Registration (21 CFR Part 207) and the submission of technical validation data meet US standards prior to PAI.

🛠️ Our Process Validation Services for the U.S. Market

We provide complete, scientifically sound, and document-intensive support to meet the FDA's expectations for a validated state of control.

ServiceU.S. / FDA / cGMP FocusLifecycle PV DocumentationPreparation of detailed Process Design, PPQ Protocols, PPQ Reports, and CPV Plans aligned with the 2011 FDA Guidance.AMV & Method TransferPreparation of detailed Analytical Method Validation (AMV) reports (compliant with ICH Q2(R1)) and method transfer protocols/reports.Cleaning ValidationDesigning and reporting on cleaning validation studies, ensuring compliance with 21 CFR Part 211 and addressing "worst-case" scenarios.eCTD Module 3 IntegrationStructuring and summarizing validation reports for seamless integration into the Quality Module (Module 3) of the eCTD submission.Data Integrity ReviewAuditing validation processes and systems for compliance with 21 CFR Part 11 requirements for electronic data integrity.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards of the FDA:

• 21 CFR Part 211: Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals.

• FDA Guidance for Industry: Process Validation (2011): The mandatory three-stage lifecycle model.

• ICH Q8, Q9, Q10: The globally recognized quality systems that guide the FDA's modern approach to risk management and process control.

🤝 Get Started on Your FDA Validation

Ensure your process validation documentation is scientifically sound, fully compliant with cGMP, and ready for FDA review and PAI, securing your market approval in the United States.

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

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

• Target Status: NDA/ANDA/BLA Submission / PAI Readiness

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission date / Inspection date

• Existing Data: Current validation master plan, protocols, or PAI deficiency letters.