🇦🇷 ValiPro: ANMAT, High-Vigilance GMP & CTD Process Validation Services for Argentina

Navigate Argentina's Rigorous Regulatory System with Validation Documentation Aligned to ANMAT's High-Vigilance Standards and International Guidelines.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers targeting the Argentine market. Our documentation is built for full compliance with the strict standards enforced by ANMAT.

Key compliance pillars include:

• Mandatory adherence to ANMAT's own Good Manufacturing Practice (GMP) standards, which are influenced by ICH and WHO guidelines. ANMAT is a member of PIC/S.

• The registration dossier requires extensive documentation outlining the product's composition, manufacturing processes, and quality control methods.

• Streamlined registration for products approved by high-surveillance authorities (HSA) in Annex I countries.

🌟 Why ANMAT Validation is Crucial

ANMAT employs a risk-based, science-driven approach to assessment, demanding that quality data be comprehensive, auditable, and presented in a structured format.

• ANMAT GMP & PIC/S: ANMAT requires the submission of a GMP certificate issued by the authority itself (upon inspection) or by other authorities recognized as a reference (Annex I countries: US, EU members, Japan, Canada, etc.). As a PIC/S member, ANMAT's GMP requirements are highly detailed and process validation must align with the full lifecycle approach (ICH Q8, Q9, Q10).

• CTD/Non-CTD Dossier: ANMAT accepts both the internationally standardized Common Technical Document (CTD) format and a Non-CTD format. The CTD format is generally preferred, with validation summaries and reports integrated into Module 3 (Quality).

• Streamlined Registration for HSA-Approved Products (Article 4): For drug products manufactured in an Annex I country and/or currently marketed in an Annex I country, the registration process is significantly simplified, relying heavily on the Certificate of Pharmaceutical Product (CoPP). However, ANMAT retains the right to request the full technical information, including Process Validation Reports, to verify quality claims made by the SRA.

• First Batch Verification: For the first product release of new or significantly varied drug products, a "first batch verification" procedure applies, requiring an analytical transfer and submission of results. This step necessitates flawless Analytical Method Validation (AMV) and fully validated production processes.

• Biologic Products: ANMAT has specific and highly detailed regulations for the registration of biological and biotechnological products (Provision No. 7075/11), requiring even more in-depth process characterization and validation data (e.g., proof of production consistency).

🎯 Compliance Focus: Who We Support

We work with international manufacturers targeting the Argentine market:

• HSA Exporters: Utilizing the streamlined registration process by providing perfectly aligned technical summaries that support the SRA/WLA approval.

• Standard Registration: Companies pursuing the standard national route, needing detailed quality documentation for the ANMAT scientific assessment.

• First Batch Readiness: Firms preparing for the mandatory first batch verification by ensuring robust analytical method validation and process control data.

• CTD Module 3 Quality: Firms needing expert preparation of the Quality Module to meet ANMAT's technical standards.

🛠️ Our Process Validation Services for Argentina

We provide complete, scientifically sound, and document-intensive support to meet ANMAT's high-vigilance expectations for quality data.

ServiceArgentina / ANMAT / CTD FocusPVP & PVR PreparationProtocols and reports aligned with PIC/S and ICH Q8/Q9/Q10 principles, suitable for submission as technical information or for audit.CTD Module 3 IntegrationStructuring validation summaries and data precisely for the CTD Module 3 (section 3.2.P.3.5) or the equivalent Non-CTD quality section.First Batch Verification SupportPreparing the necessary documentation (e.g., analytical method transfer protocol/report) to facilitate the successful completion of the first batch verification.Spanish Translation SupportAssistance in the accurate translation of technical validation summaries and key quality documents into Spanish for submission.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards adopted and enforced by ANMAT:

• Decree No. 150/1992: The foundational law establishing drug registration rules.

• ANMAT GMP Dispositions: The mandatory national manufacturing practice guidelines.

• ICH Quality Principles (Q8, Q9, Q10): The underlying scientific foundation for validation, recognized by ANMAT as a high-vigilance agency.

🤝 Get Started on Your Argentina Validation

Ensure your process validation documentation is robust, correctly formatted, and immediately acceptable to ANMAT, securing your necessary approvals and market access in Argentina.

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

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

• Target Status: Article 4 Streamlined Registration / Standard Registration

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission date

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