NUESTRA COMPAÑÍA: Pan Am Farma CERTIFICATE OF QUALITY STANDARDS
Pan Am Farma 1. Introduction
Distribuidora Farmacéutico Pan Americana SA de CV (Panamfarma) is committed to upholding the highest international standards of quality, safety, and compliance in the manufacturing, distribution, and supply of pharmaceuticals for both local and export markets.
This document certifies that all pharmaceutical products handled by Panamfarma meet stringent Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and regulatory requirements established by international health authorities.
Pan Am Farma 2. Quality Assurance and Compliance
Our company operates under strict adherence to the following international and national quality and regulatory frameworks:
- Good Manufacturing Practices (GMP)
- Good Distribution Practices (GDP)
- World Health Organization (WHO) Guidelines for Pharmaceutical Quality Assurance
- Mexican Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) Regulations
- European Medicines Agency (EMA) Guidelines (where applicable)
- U.S. Food and Drug Administration (FDA) Standards (where applicable)
- ISO 9001:2015 (Quality Management System)
- ISO 13485:2016 (Medical Devices – Quality Management Systems, where applicable)
All pharmaceutical and biopharmaceutical products sourced, imported, and distributed by Panamfarma comply with pharmacopoeial standards such as:
- United States Pharmacopeia (USP)
- European Pharmacopoeia (Ph. Eur.)
- British Pharmacopoeia (BP)
- Mexican Pharmacopeia (FEUM)
Fabricación de farmacéuticas 3. Certifications & Approvals
Panamfarma, along with its manufacturing and supply chain partners, adheres to the following certifications:
- GMP Certification (Issued by relevant regulatory authorities)
- GDP Certification (For pharmaceutical supply and distribution)
- ISO 9001:2015 Certification (Quality Management Systems – if applicable)
- COFEPRIS Authorization (Mexican Regulatory Approval for Pharmaceutical Distribution)
- Export Compliance Certificates (For shipments to regulated international markets)
- Customs and Trade Compliance Certification (For pharmaceutical export and import clearance)
All pharmaceutical products are tested and validated in compliance with the standards set by the respective regulatory agencies of the importing country.
Pan Am Farma 4. Quality Control & Testing Protocols
All products are subjected to rigorous quality control (QC) testing at every stage of the supply chain, including:
- Raw Material Testing – Ensuring purity, potency, and compliance with pharmacopoeial standards.
- In-Process Control (IPC) – Quality checks during the manufacturing process.
- Finished Product Testing – Verification of product stability, sterility, and efficacy.
- Batch Release Testing – Conducted by certified laboratories before distribution.
- Temperature & Storage Compliance – All cold chain and temperature-sensitive products are stored and transported under validated conditions.
5. Commitment to Continuous Improvement
Distribuidora Farmacéutico Pan Americana SA de CV continuously reviews and improves its quality standards through:
- Regular audits and inspections (internal and external)
- Employee training programs on GDP/GMP compliance
- Pharmacovigilance and post-market surveillance
- Implementation of new regulatory and technological advancements
Pan Am Farma 6. Authorized Signatory
The Certificate of Quality Standards are issued as an official document confirming Panamfarma’s commitment to regulatory compliance and quality excellence in pharmaceutical manufacturing, distribution, and exports.
CONTACT Información de Contacto
- Oficina México: Avenida Paseo de la Reforma, Ciudad de México, CDMX 06500
- Oficina/Bodega: 527 21stStreet, Unit 356, Galveston, Texas USA 77550
- Planta de Fabricación 1: Bhaskar Bhau Lane, Gamdevi, Mumbai 400007, Maharashtra-India
- Planta de Fabricación 2: Adolfo López Mateos, Ecatepec de Morelos, Edo. Méx., Mexico 55540
- Correo Electrónico: info@panamfarma.com
- Teléfono: +52 322 308 0021 / +1 713 322 9272
- WhatsApp: +1 409 789 9957
