🇬🇹 ValiPro: DRCPFA, RTCA & Mandatory AMV Validation Services for Guatemala

Secure Product Registration in Guatemala by Meeting the DRCPFA's Documentation Requirements and Ensuring Compliance with Central American Technical Regulations (RTCA).

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

Key compliance pillars include:

• Mandatory submission of a Good Manufacturing Practice (GMP) Certificate (or CoPP).

• Explicit requirement for Analytical Method Validation (AMV) reports, particularly for solid oral dosage forms.

• Mandatory submission of samples and standards for testing by the National Health Laboratory (LNS) in the standard registration route.

🌟 Why DRCPFA Validation is Crucial

Guatemala's registration process is highly documented and involves mandatory laboratory verification, making robust validation data essential for both dossier approval and passing quality control tests.

• Mandatory Analytical Method Validation (AMV): The registration dossier checklist explicitly requires the Method of Analysis of Finished Product and the Validation of the Method / Dissolution. For solid pharmaceutical forms, the validation of the dissolution method is particularly emphasized. This AMV must be detailed, clear, and ensure the method's conditions are easily reproducible by the National Health Laboratory (LNS).

• Laboratory Testing (LNS): In the normal registration process, the dossier, samples of the finished product, and reference standards must be submitted to the LNS. The DRCPFA waits for the LNS analysis results before approving the procedure. Your process validation ensures batch quality, and the AMV ensures the control methods are sound for this mandatory verification.

• GMP Compliance: A Certificate of Good Manufacturing Practices (GMP) or a Certificate of Pharmaceutical Product (CoPP), duly legalized (Apostilled/attested), is mandatory. The submitted technical data, including the stability study results for three batches and the process validation protocols/reports, must scientifically support the claims made in the GMP certificate.

• Dossier Content: The dossier must include the Quali-quantitative Formula, Technical Specifications of the Finished Product, and Stability Study data (accelerated and real-time for three batches) with a conclusion. Process validation reports are a necessary complement to the description of the manufacturing process and in-process controls.

• Language Requirement: All documents submitted to the authority must be in Spanish or accompanied by a sworn translation.

🎯 Compliance Focus: Who We Support

We work with international manufacturers targeting the Guatemalan market:

• Standard Registration Applicants: Companies preparing the paper-heavy dossier for submission to both the DRCPFA and the LNS.

• High Vigilance Agency (HVA) Approval: Firms utilizing the expedited route for products already approved by an SRA, still needing to maintain the high-quality technical dossier (though samples and standards may be waived).

• Analytical Validation: Firms needing robust AMV reports specifically compliant with the DRCPFA's explicit requirements, including dissolution method validation for solid dosage forms.

🛠️ Our Process Validation Services for Guatemala and RTCA

We provide complete, scientifically sound, and document-intensive support tailored to the content requirements of the DRCPFA.

ServiceGuatemala / DRCPFA / LNS FocusPVP & PVR PreparationProtocols and reports aligned with WHO/ICH GMP principles, documenting the manufacturing and cleaning processes. Submission of 3 batches process validation reports and/or protocols is generally required.Analytical Method Validation (AMV)Preparation of detailed Validation of the Method / Dissolution reports, ensuring the procedure is fully detailed and reproducible for the LNS testing.Stability Data Generation SupportReview and structuring of stability data for three batches (accelerated and real-time) to meet the DRCPFA's specific format and condition requirements ($40^{\circ}C \pm 2^{\circ}C$ and $75\% \pm 5\% RH$).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 the DRCPFA:

• Central American Technical Regulations (RTCA): The harmonized regional regulations governing product quality and registration.

• WHO GMP Guidelines: The internationally accepted standard for manufacturing practice compliance.

• National Registration Guide: The specific technical document checklist published by the DRCPFA.

🤝 Get Started on Your Guatemala Validation

Ensure your process validation and analytical method validation documentation is robust, correctly translated, and immediately acceptable to the DRCPFA and the LNS, securing your necessary approvals and market access in Guatemala.

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

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

• Target Status: Normal Registration / HVA Approval Route

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission date

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