🇦🇫 ValiPro: AFDA (Afghanistan) WHO-GMP Validation Services

Assist Foreign Manufacturers in Preparing Necessary GMP and Validation Documentation to Obtain Product Registration and Import Licenses from the AFDA.

ValiPro supports pharmaceutical companies seeking to supply the Afghan market by ensuring their manufacturing sites and quality documentation meet the required international standards, primarily those set by the World Health Organization (WHO).

Key compliance pillars for market access in Afghanistan include:

• National Authority (AFDA): Responsible for registration, licensing, inspection, and quality control of medicines. The AFDA also maintains the National Licensed Medicines List (LML), and only registered medicines may be imported.

• Manufacturing Standard (WHO-GMP): The AFDA's inspection and regulatory guidelines are based on WHO-delineated Good Manufacturing Practice (GMP). Compliance with this international standard is mandatory for both domestic and foreign suppliers.

• Pharmacopoeia Recognition: Afghanistan has formally recognized the Indian Pharmacopoeia (IP) as an official standard, alongside other reputable international pharmacopoeias, which impacts analytical method validation.

• Import Requirement: All imported medicines must be registered with the AFDA, and the foreign manufacturing company must also be registered and hold a valid export license.

🌟 Why Validation is Crucial for AFDA Compliance

Validation documentation is a mandatory requirement for foreign manufacturing sites seeking to register their products with the AFDA.

1. Mandatory Submission of GMP and Validation Data

The AFDA requires extensive documentation from foreign companies seeking to register their products. This documentation must demonstrate the quality and consistency of the manufacturing process, which fundamentally relies on validation:

• GMP Certification: Companies must provide GMP certification (e.g., WHO-GMP) of the produced medicine from their country of origin and, ideally, an internationally recognized body.

• Quality Control Documents: Submission requires comprehensive Quality Control documents from the manufacturing company's laboratory, and secondary approval analyses from the origin country's central laboratories.

• Specific Documents: Required product-specific documents that rely on a validated state include:

  • List of formulation (including standard formulation of the medicine).

  • Procedure for controlling the production process.

  • Documents of analysis and method of analysis.

  • Reliability of the method of analysis certification (Analytical Method Validation).

2. Adherence to WHO-GMP Guidelines

The AFDA's inspection checklist for both domestic and foreign sites is based on WHO-delineated GMP guidelines. Although domestic compliance with validation has been cited as a challenging area in various reports, foreign manufacturers must adhere to high standards:

• Validation and Qualification Practices: The WHO-GMP guidance explicitly mandates Qualification and Validation as a critical component of the Quality System.

• Key Focus Areas (for inspection): Inspections will scrutinize areas like Quality Assurance/Quality Control (QC) laboratories, Water Systems, and HVAC systems, all of which require meticulous validation and qualification.

3. AFDA's Role in Quality Control

The AFDA's Medicines and Food Quality Control Directorate (MFQCD) handles quality control activities, including post-market surveillance. The central medicine analyzing laboratories in Afghanistan perform independent analysis on imported samples.

• Sample Analysis: Registration requires analysis of the medicine samples in the AFDA's general medicine analyzing laboratories. The quality and purity of the product must match the submitted specifications, which are derived from a validated manufacturing process.

🎯 Compliance Focus: Who We Support

We work with foreign manufacturers targeting the Afghan market:

• Indian Manufacturers: Given the formal recognition of the Indian Pharmacopoeia, we assist Indian (and other international) manufacturers in compiling their WHO-GMP-certified documentation to streamline the AFDA registration process.

• Export License Applicants: Providing the necessary technical validation summaries and GMP documentation required to obtain the company's registration certificate and subsequent product-specific import licenses.

• Companies Seeking First-Time AFDA Registration: Guidance on structuring the dossier according to AFDA's specific list of required technical and administrative documents.

🛠️ Our Validation Services for AFDA Compliance

We provide robust, internationally accepted (WHO-GMP compliant) validation documentation ready for AFDA submission.

ServiceAFDA / WHO-GMP FocusWHO-GMP VMP & PVDevelopment of a Validation Master Plan (VMP) and Process Validation documentation aligned with WHO guidelines to support GMP certification.Analytical Method Validation (AMV)Execution and reporting of Method Validation studies (ICH Q2 principles) for all QC tests, ensuring alignment with recognized pharmacopoeias (e.g., IP, BP, USP).Cleaning ValidationDesigning and executing Cleaning Validation protocols to prevent cross-contamination, a key component of GMP compliance.Documentation ReviewReview of existing GMP and validation documents to ensure they meet the specific AFDA requirements for foreign product registration.

🤝 Next Step: Secure AFDA Product Registration

Ensure your manufacturing site's GMP and validation status is clearly documented to support your product registration and importation efforts in Afghanistan.

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

• Product: Active Pharmaceutical Ingredient (API) or Finished Formulation

• Status: First-time registration / Renewal

• Current GMP Certification: (e.g., WHO-GMP, EU GMP, FDA)

• Timeline: Target submission date for AFDA